Transmucosal Drug Delivery Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Transmucosal Drug Delivery Pipeline Market Report Overview

A Transmucosal drug delivery device is intended for the localized delivery of medications through a mucous membrane. The transmucosal drug delivery pipeline market research report provides comprehensive information about the transmucosal drug delivery pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Key Segment ·       Nasal

·       Vaginal

·       Buccal Delivery

·       Rectal

Key Territories ·       The US

·       Europe

·       China

·       India

·       Japan

Key Regulatory Paths ·       510(k)

·       CE

·       NMPA

·       TGA

·       Ninsho

Leading Companies ·       AcelRx Pharmaceuticals Inc

·       AFYX Therapeutics A/S

·       Albert Einstein College of Medicine

·       Allergan Ltd

·       Altamira Medica AG

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Transmucosal Drug Delivery Pipeline Market Segments

Some of the key segments in the transmucosal drug delivery market are nasal, vaginal, buccal delivery, and rectal. The nasal segment is leading the market in 2023.

Transmucosal Drug Delivery Pipeline Market Analysis, by Segments, 2023 (%)

Transmucosal Drug Delivery Pipeline Market Analysis, by Segments, 2023 (%)

For more segments insights into the transmucosal drug delivery pipeline market, download a free report sample

Transmucosal Drug Delivery Pipeline Market Segmentation by Territories

Some of the key territories in the transmucosal drug delivery market are the US, Europe, China, India, and Japan among others. As of June 2023, the US had the highest number of pipeline products.

Transmucosal Drug Delivery Pipeline Market Analysis, by Territories, 2023 (%)

Transmucosal Drug Delivery Pipeline Market Analysis, by Territories, 2023 (%)

or more territory insights into the transmucosal drug delivery pipeline market, download a free report sample

Transmucosal Drug Delivery Pipeline Market Segmentation by Regulatory Paths

Some of the regulatory paths in the transmucosal drug delivery pipeline market are 510(k), NMPA, TGA, CE, and Ninsho among others. As of June 2023, 510(k) was the most followed pathway for pipeline products.

Transmucosal Drug Delivery Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

Transmucosal Drug Delivery Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

For more regulatory path insights into the transmucosal drug delivery pipeline market, download a free report sample

Transmucosal Drug Delivery Pipeline Market – Competitive Landscape

Some of the key companies in the transmucosal drug delivery pipeline market are AcelRx Pharmaceuticals Inc, AFYX Therapeutics A/S, Albert Einstein College of Medicine, Allergan Ltd, and Altamira Medica AG among others.

AcelRx Pharmaceuticals Inc: AcelRx Pharmaceuticals Inc (AcelRx), is a specialty pharmaceutical company that develops and commercializes drugs for the treatment of pain. The company’s lead product candidate, Dsuvia (known as Dzuveo in Europe), is a single sufentanil sublingual tablet for treating moderate-to-severe acute pain. Its pipeline also includes Zalviso (for the US market), a drug and device combination product for the management of moderate to severe acute pain in adults. AcelRx developed a proprietary, non-invasive, sublingual formulation technology to deliver its highly lipophilic drugs. The company commercializes its EC-approved Zalviso under a license agreement with Grunenthal in Europe and Australia. AcelRx is headquartered in Hayward, California, the US.

Segments Covered in the Report

Transmucosal Drug Delivery Pipeline Market Segments Outlook

  • Nasal
  • Vaginal
  • Buccal delivery
  • Rectal

Transmucosal Drug Delivery Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • India
  • Japan

Transmucosal Drug Delivery Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE
  • NMPA
  • TGA
  • Ninsho

Scope

  • Extensive coverage of the transmucosal drug delivery under development
  • Reviews details of major pipeline products which include, product description, licensing and collaboration details, and other developmental activities
  • Reviews the major players involved in the development of transmucosal drug delivery and list all their pipeline projects
  • The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
  • The report provides key clinical trial data of ongoing trials specific to pipeline products
  • Recent developments in the segment/industry

Reasons to Buy

The report enables you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage
  • Identify and understand important and diverse types of transmucosal drug delivery under development
  • Develop market-entry and market expansion strategies
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date

AcelRx Pharmaceuticals Inc
AFYX Therapeutics A/S
Albert Einstein College of Medicine
Allergan Ltd
Altamira Medica AG
Anelleo Inc
Aquestive Therapeutics Inc
Arovella Therapeutics Ltd
ARS Pharmaceuticals, Inc.
Atossa Therapeutics Inc
Auris Medical AG
Auritec Pharmaceuticals Inc
BeFree!
Bespak Europe Ltd
Biorings LLC
BioXcel Therapeutics Inc
Birmingham Biotech Ltd
Bryn Pharma LLC
Callitas Therapeutics Inc
Chulalongkorn University
Combinent BioMedical Systems Inc
Conrad
Covidrops LLP
Dare Bioscience Inc
Eledon Pharmaceuticals Inc
Emergent BioSolutions Inc
EmphyCorp Inc
Ena Respiratory Pty Ltd
Eureka Therapeutics Inc
Eveon SAS
Evestra Inc
Evofem Biosciences Inc
Ferring Pharmaceuticals AS
Firebrick Pharma Pty Ltd
GeneOne Life Science Inc
Ghent University
Glenmark Pharmaceuticals Ltd
Grasses of Eden Ltd
Grunenthal Ltd
Halberd Corp
Harm Reduction Therapeutics Inc
Hebrew University of Jerusalem
Hikma Pharmaceuticals Plc
Imbed Biosciences Inc
Institute for Research and Innovation in Health
Insys Therapeutics Inc (Inactive)
IntelGenx Corp
International Partnership For Microbicides
ITC Life Sciences and Technology Centre
ITF Pharma Inc
Janssen Sciences Ireland UC
Kane Biotech Inc
Karessa Pharma AB
Karp Lab
Kiora Pharmaceuticals Inc
Kytogenics Pharmaceuticals Inc
Laboratoire HRA Pharma SAS
Lachesis Biosciences Ltd
Leyden Laboratories BV
Lobe Sciences Ltd
Lyra Therapeutics Inc
Magee-Womens Research Institute
MassBiologics
McNeil AB
Medlab Clinical Ltd
Merck & Co Inc
Merck Serono SA
Mucommune LLC
Mycrodose Therapeutics Inc
Mystic Pharmaceuticals Inc
Nanosys Inc
Nasus Medical Inc
Nasus Pharma Ltd
Nemera La Verpilliere
NorInvent AB
Novlead Biotechnology Co Ltd
Olfax LLC
Opiant Pharmaceuticals Inc
OptiNose AS
OptiNose Inc
Organon Pharma (UK) Ltd
Orion Biotechnology Canada Ltd
Orphanse Healthcare SAS
Oyster Point Pharma Inc
P&B Group
Palette Life Sciences AB
Parnell Pharmaceuticals Inc
Phoenix Life Sciences International Ltd
pHOXBIO Ltd
Pocket Naloxone Corp
Polyrizon Ltd
RDD Pharma Ltd (Inactive)
Receptor Life Sciences Inc
Renown Pharmaceuticals Pvt Ltd
Rhinomed Ltd
Sanotize Research and Development Corp
Scientus Pharma Inc
Seelos Therapeutics, Inc.
Shin Nippon Biomedical Laboratories Ltd
SipNose Ltd
South Valley University
Starpharma Holdings Ltd
The Population Council Inc
Therakind Ltd
Union Therapeutics AS
University of California Davis
University of Erlangen-Nurnberg
University of Kentucky
University of Louisville
University of Melbourne
University of North Carolina at Chapel Hill
University of Pittsburgh
University of South Florida
University of Texas at Austin
University of the Witwatersrand
University of Waterloo
Virpax Pharmaceuticals Inc
VistaGen Therapeutics Inc
Washington University in St Louis
Wellfully Ltd
Xlear Inc
Zydus Healthcare Ltd

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 9

|1.2 List of Figures 19

2 Introduction 20

2.1 Transmucosal Drug Delivery Overview 20

3 Products under Development 21

3.1 Transmucosal Drug Delivery – Pipeline Products by Stage of Development 21

3.2 Transmucosal Drug Delivery – Pipeline Products by Segment 22

3.3 Transmucosal Drug Delivery – Pipeline Products by Territory 23

3.4 Transmucosal Drug Delivery – Pipeline Products by Regulatory Path 25

3.5 Transmucosal Drug Delivery – Pipeline Products by Estimated Approval Date 26

3.6 Transmucosal Drug Delivery – Ongoing Clinical Trials 27

4 Transmucosal Drug Delivery – Pipeline Products under Development by Companies 28

4.1 Transmucosal Drug Delivery Companies – Pipeline Products by Stage of Development 28

4.2 Transmucosal Drug Delivery – Pipeline Products by Stage of Development 33

5 Transmucosal Drug Delivery Companies and Product Overview 37

5.1 AcelRx Pharmaceuticals Inc Company Overview 37

5.1.1 AcelRx Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 37

5.2 AFYX Therapeutics A/S Company Overview 41

5.2.1 AFYX Therapeutics A/S Pipeline Products & Ongoing Clinical Trials Overview 41

5.3 Albert Einstein College of Medicine Company Overview 42

5.3.1 Albert Einstein College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 42

5.4 Allergan Ltd Company Overview 43

5.4.1 Allergan Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

5.5 Altamira Medica AG Company Overview 44

5.5.1 Altamira Medica AG Pipeline Products & Ongoing Clinical Trials Overview 44

5.6 Anelleo Inc Company Overview 47

5.6.1 Anelleo Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.7 Aquestive Therapeutics Inc Company Overview 48

5.7.1 Aquestive Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.8 Arovella Therapeutics Ltd Company Overview 49

5.8.1 Arovella Therapeutics Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

5.9 ARS Pharmaceuticals, Inc. Company Overview 50

5.9.1 ARS Pharmaceuticals, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50

5.10 Atossa Therapeutics Inc Company Overview 51

5.10.1 Atossa Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.11 Auris Medical AG Company Overview 52

5.11.1 Auris Medical AG Pipeline Products & Ongoing Clinical Trials Overview 52

5.12 Auritec Pharmaceuticals Inc Company Overview 54

5.12.1 Auritec Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 54

5.13 BeFree! Company Overview 64

5.13.1 BeFree! Pipeline Products & Ongoing Clinical Trials Overview 64

5.14 Bespak Europe Ltd Company Overview 65

5.14.1 Bespak Europe Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

5.15 Biorings LLC Company Overview 67

5.15.1 Biorings LLC Pipeline Products & Ongoing Clinical Trials Overview 67

5.16 BioXcel Therapeutics Inc Company Overview 68

5.16.1 BioXcel Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.17 Birmingham Biotech Ltd Company Overview 72

5.17.1 Birmingham Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

5.18 Bryn Pharma LLC Company Overview 73

5.18.1 Bryn Pharma LLC Pipeline Products & Ongoing Clinical Trials Overview 73

5.19 Callitas Therapeutics Inc Company Overview 74

5.19.1 Callitas Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 74

5.20 Chulalongkorn University Company Overview 75

5.20.1 Chulalongkorn University Pipeline Products & Ongoing Clinical Trials Overview 75

5.21 Combinent BioMedical Systems Inc Company Overview 76

5.21.1 Combinent BioMedical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 76

5.22 Conrad Company Overview 77

5.22.1 Conrad Pipeline Products & Ongoing Clinical Trials Overview 77

5.23 Covidrops LLP Company Overview 80

5.23.1 Covidrops LLP Pipeline Products & Ongoing Clinical Trials Overview 80

5.24 Dare Bioscience Inc Company Overview 81

5.24.1 Dare Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 81

5.25 Eledon Pharmaceuticals Inc Company Overview 86

5.25.1 Eledon Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.26 Emergent BioSolutions Inc Company Overview 87

5.26.1 Emergent BioSolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.27 EmphyCorp Inc Company Overview 90

5.27.1 EmphyCorp Inc Pipeline Products & Ongoing Clinical Trials Overview 90

5.28 Ena Respiratory Pty Ltd Company Overview 91

5.28.1 Ena Respiratory Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

5.29 Eureka Therapeutics Inc Company Overview 94

5.29.1 Eureka Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.30 Eveon SAS Company Overview 95

5.30.1 Eveon SAS Pipeline Products & Ongoing Clinical Trials Overview 95

5.31 Evestra Inc Company Overview 96

5.31.1 Evestra Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.32 Evofem Biosciences Inc Company Overview 100

5.32.1 Evofem Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 100

5.33 Ferring Pharmaceuticals AS Company Overview 102

5.33.1 Ferring Pharmaceuticals AS Pipeline Products & Ongoing Clinical Trials Overview 102

5.34 Firebrick Pharma Pty Ltd Company Overview 104

5.34.1 Firebrick Pharma Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 104

5.35 GeneOne Life Science Inc Company Overview 108

5.35.1 GeneOne Life Science Inc Pipeline Products & Ongoing Clinical Trials Overview 108

5.36 Ghent University Company Overview 109

5.36.1 Ghent University Pipeline Products & Ongoing Clinical Trials Overview 109

5.37 Glenmark Pharmaceuticals Ltd Company Overview 110

5.37.1 Glenmark Pharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

5.38 Grasses of Eden Ltd Company Overview 114

5.38.1 Grasses of Eden Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

5.39 Grunenthal Ltd Company Overview 117

5.39.1 Grunenthal Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

5.40 Halberd Corp Company Overview 119

5.40.1 Halberd Corp Pipeline Products & Ongoing Clinical Trials Overview 119

5.41 Harm Reduction Therapeutics Inc Company Overview 120

5.41.1 Harm Reduction Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 120

5.42 Hebrew University of Jerusalem Company Overview 121

5.42.1 Hebrew University of Jerusalem Pipeline Products & Ongoing Clinical Trials Overview 121

5.43 Hikma Pharmaceuticals Plc Company Overview 122

5.43.1 Hikma Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 122

5.44 Imbed Biosciences Inc Company Overview 124

5.44.1 Imbed Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 124

5.45 Institute for Research and Innovation in Health Company Overview 125

5.45.1 Institute for Research and Innovation in Health Pipeline Products & Ongoing Clinical Trials Overview 125

5.46 Insys Therapeutics Inc (Inactive) Company Overview 126

5.46.1 Insys Therapeutics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 126

5.47 IntelGenx Corp Company Overview 128

5.47.1 IntelGenx Corp Pipeline Products & Ongoing Clinical Trials Overview 128

5.48 International Partnership For Microbicides Company Overview 131

5.48.1 International Partnership For Microbicides Pipeline Products & Ongoing Clinical Trials Overview 131

5.49 ITC Life Sciences and Technology Centre Company Overview 134

5.49.1 ITC Life Sciences and Technology Centre Pipeline Products & Ongoing Clinical Trials Overview 134

5.50 ITF Pharma Inc Company Overview 135

5.50.1 ITF Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 135

5.51 Janssen Sciences Ireland UC Company Overview 136

5.51.1 Janssen Sciences Ireland UC Pipeline Products & Ongoing Clinical Trials Overview 136

5.52 Kane Biotech Inc Company Overview 139

5.52.1 Kane Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 139

5.53 Karessa Pharma AB Company Overview 140

5.53.1 Karessa Pharma AB Pipeline Products & Ongoing Clinical Trials Overview 140

5.54 Karp Lab Company Overview 143

5.54.1 Karp Lab Pipeline Products & Ongoing Clinical Trials Overview 143

5.55 Kiora Pharmaceuticals Inc Company Overview 144

5.55.1 Kiora Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 144

5.56 Kytogenics Pharmaceuticals Inc Company Overview 146

5.56.1 Kytogenics Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 146

5.57 Laboratoire HRA Pharma SAS Company Overview 147

5.57.1 Laboratoire HRA Pharma SAS Pipeline Products & Ongoing Clinical Trials Overview 147

5.58 Lachesis Biosciences Ltd Company Overview 148

5.58.1 Lachesis Biosciences Ltd Pipeline Products & Ongoing Clinical Trials Overview 148

5.59 Leyden Laboratories BV Company Overview 149

5.59.1 Leyden Laboratories BV Pipeline Products & Ongoing Clinical Trials Overview 149

5.60 Lobe Sciences Ltd Company Overview 150

5.60.1 Lobe Sciences Ltd Pipeline Products & Ongoing Clinical Trials Overview 150

5.61 Lyra Therapeutics Inc Company Overview 151

5.61.1 Lyra Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 151

5.62 Magee-Womens Research Institute Company Overview 156

5.62.1 Magee-Womens Research Institute Pipeline Products & Ongoing Clinical Trials Overview 156

5.63 MassBiologics Company Overview 157

5.63.1 MassBiologics Pipeline Products & Ongoing Clinical Trials Overview 157

5.64 McNeil AB Company Overview 158

5.64.1 McNeil AB Pipeline Products & Ongoing Clinical Trials Overview 158

5.65 Medlab Clinical Ltd Company Overview 159

5.65.1 Medlab Clinical Ltd Pipeline Products & Ongoing Clinical Trials Overview 159

5.66 Merck & Co Inc Company Overview 162

5.66.1 Merck & Co Inc Pipeline Products & Ongoing Clinical Trials Overview 162

5.67 Merck Serono SA Company Overview 163

5.67.1 Merck Serono SA Pipeline Products & Ongoing Clinical Trials Overview 163

5.68 Mucommune LLC Company Overview 164

5.68.1 Mucommune LLC Pipeline Products & Ongoing Clinical Trials Overview 164

5.69 Mycrodose Therapeutics Inc Company Overview 167

5.69.1 Mycrodose Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 167

5.70 Mystic Pharmaceuticals Inc Company Overview 168

5.70.1 Mystic Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 168

5.71 Nanosys Inc Company Overview 170

5.71.1 Nanosys Inc Pipeline Products & Ongoing Clinical Trials Overview 170

5.72 Nasus Medical Inc Company Overview 171

5.72.1 Nasus Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 171

5.73 Nasus Pharma Ltd Company Overview 172

5.73.1 Nasus Pharma Ltd Pipeline Products & Ongoing Clinical Trials Overview 172

5.74 Nemera La Verpilliere Company Overview 173

5.74.1 Nemera La Verpilliere Pipeline Products & Ongoing Clinical Trials Overview 173

5.75 NorInvent AB Company Overview 174

5.75.1 NorInvent AB Pipeline Products & Ongoing Clinical Trials Overview 174

5.76 Novlead Biotechnology Co Ltd Company Overview 175

5.76.1 Novlead Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

5.77 Olfax LLC Company Overview 176

5.77.1 Olfax LLC Pipeline Products & Ongoing Clinical Trials Overview 176

5.78 Opiant Pharmaceuticals Inc Company Overview 177

5.78.1 Opiant Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 177

5.79 OptiNose AS Company Overview 181

5.79.1 OptiNose AS Pipeline Products & Ongoing Clinical Trials Overview 181

5.80 OptiNose Inc Company Overview 185

5.80.1 OptiNose Inc Pipeline Products & Ongoing Clinical Trials Overview 185

5.81 Organon Pharma (UK) Ltd Company Overview 186

5.81.1 Organon Pharma (UK) Ltd Pipeline Products & Ongoing Clinical Trials Overview 186

5.82 Orion Biotechnology Canada Ltd Company Overview 187

5.82.1 Orion Biotechnology Canada Ltd Pipeline Products & Ongoing Clinical Trials Overview 187

5.83 Orphanse Healthcare SAS Company Overview 188

5.83.1 Orphanse Healthcare SAS Pipeline Products & Ongoing Clinical Trials Overview 188

5.84 Oyster Point Pharma Inc Company Overview 189

5.84.1 Oyster Point Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 189

5.85 P&B Group Company Overview 190

5.85.1 P&B Group Pipeline Products & Ongoing Clinical Trials Overview 190

5.86 Palette Life Sciences AB Company Overview 193

5.86.1 Palette Life Sciences AB Pipeline Products & Ongoing Clinical Trials Overview 193

5.87 Parnell Pharmaceuticals Inc Company Overview 194

5.87.1 Parnell Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 194

5.88 Phoenix Life Sciences International Ltd Company Overview 195

5.88.1 Phoenix Life Sciences International Ltd Pipeline Products & Ongoing Clinical Trials Overview 195

5.89 pHOXBIO Ltd Company Overview 198

5.89.1 pHOXBIO Ltd Pipeline Products & Ongoing Clinical Trials Overview 198

5.90 Pocket Naloxone Corp Company Overview 201

5.90.1 Pocket Naloxone Corp Pipeline Products & Ongoing Clinical Trials Overview 201

5.91 Polyrizon Ltd Company Overview 202

5.91.1 Polyrizon Ltd Pipeline Products & Ongoing Clinical Trials Overview 202

5.92 RDD Pharma Ltd (Inactive) Company Overview 203

5.92.1 RDD Pharma Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 203

5.93 Receptor Life Sciences Inc Company Overview 204

5.93.1 Receptor Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 204

5.94 Renown Pharmaceuticals Pvt Ltd Company Overview 205

5.94.1 Renown Pharmaceuticals Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 205

5.95 Rhinomed Ltd Company Overview 206

5.95.1 Rhinomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 206

5.96 Sanotize Research and Development Corp Company Overview 207

5.96.1 Sanotize Research and Development Corp Pipeline Products & Ongoing Clinical Trials Overview 207

5.97 Scientus Pharma Inc Company Overview 210

5.97.1 Scientus Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 210

5.98 Seelos Therapeutics, Inc. Company Overview 211

5.98.1 Seelos Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 211

5.99 Shin Nippon Biomedical Laboratories Ltd Company Overview 214

5.99.1 Shin Nippon Biomedical Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 214

5.100 SipNose Ltd Company Overview 215

5.100.1 SipNose Ltd Pipeline Products & Ongoing Clinical Trials Overview 215

5.101 South Valley University Company Overview 217

5.101.1 South Valley University Pipeline Products & Ongoing Clinical Trials Overview 217

5.102 Starpharma Holdings Ltd Company Overview 218

5.102.1 Starpharma Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 218

5.103 The Population Council Inc Company Overview 219

5.103.1 The Population Council Inc Pipeline Products & Ongoing Clinical Trials Overview 219

5.104 Therakind Ltd Company Overview 220

5.104.1 Therakind Ltd Pipeline Products & Ongoing Clinical Trials Overview 220

5.105 Union Therapeutics AS Company Overview 221

5.105.1 Union Therapeutics AS Pipeline Products & Ongoing Clinical Trials Overview 221

5.106 University of California Davis Company Overview 222

5.106.1 University of California Davis Pipeline Products & Ongoing Clinical Trials Overview 222

5.107 University of Erlangen-Nurnberg Company Overview 223

5.107.1 University of Erlangen-Nurnberg Pipeline Products & Ongoing Clinical Trials Overview 223

5.108 University of Kentucky Company Overview 224

5.108.1 University of Kentucky Pipeline Products & Ongoing Clinical Trials Overview 224

5.109 University of Louisville Company Overview 227

5.109.1 University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 227

5.110 University of Melbourne Company Overview 228

5.110.1 University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview 228

5.111 University of North Carolina at Chapel Hill Company Overview 231

5.111.1 University of North Carolina at Chapel Hill Pipeline Products & Ongoing Clinical Trials Overview 231

5.112 University of Pittsburgh Company Overview 233

5.112.1 University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 233

5.113 University of South Florida Company Overview 234

5.113.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 234

5.114 University of Texas at Austin Company Overview 235

5.114.1 University of Texas at Austin Pipeline Products & Ongoing Clinical Trials Overview 235

5.115 University of the Witwatersrand Company Overview 236

5.115.1 University of the Witwatersrand Pipeline Products & Ongoing Clinical Trials Overview 236

5.116 University of Waterloo Company Overview 237

5.116.1 University of Waterloo Pipeline Products & Ongoing Clinical Trials Overview 237

5.117 Virpax Pharmaceuticals Inc Company Overview 238

5.117.1 Virpax Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 238

5.118 VistaGen Therapeutics Inc Company Overview 240

5.118.1 VistaGen Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 240

5.119 Washington University in St Louis Company Overview 244

5.119.1 Washington University in St Louis Pipeline Products & Ongoing Clinical Trials Overview 244

5.120 Wellfully Ltd Company Overview 245

5.120.1 Wellfully Ltd Pipeline Products & Ongoing Clinical Trials Overview 245

5.121 Xlear Inc Company Overview 246

5.121.1 Xlear Inc Pipeline Products & Ongoing Clinical Trials Overview 246

5.122 Zydus Healthcare Ltd Company Overview 249

5.122.1 Zydus Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 249

6 Transmucosal Drug Delivery- Recent Developments 250

6.1 May 12, 2023: Impel Pharmaceuticals announces first quarter 2023 financial results and provides business update 250

6.2 May 10, 2023: AcelRx Pharmaceuticals reports first quarter 2023 financial results and provides corporate update 251

6.3 May 04, 2023: Daré Bioscience to host Q1 2023 financial results and company update conference call and webcast on May 11, 2023 252

6.4 Apr 28, 2023: Candace Matthews elected independent chairperson of Aptar’s board of directors 253

6.5 Apr 12, 2023: Impel Pharmaceuticals Announces Appointment of Darren Cline to the Board of Directors 253

6.6 Mar 31, 2023: Daré Bioscience Reports First Quarter 2023 Financial Results and Provides a Company Update 254

6.7 Mar 30, 2023: Daré Bioscience Reports Full Year 2022 Financial Results and Provides a Company Update 256

6.8 Mar 24, 2023: Impel Pharmaceuticals Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update 259

6.9 Mar 17, 2023: Impel Pharmaceuticals to Report Fourth Quarter and Full Year 2022 Financial Results on Friday, March 24, 2023 260

6.10 Feb 16, 2023: Marinomed Biotech announces preliminary revenue for 2022 with double-digit growth for Carragelose 261

6.11 Dec 02, 2022: Neurelis to present nine posters at the 76th American Epilepsy Society Annual Meeting 261

6.12 Nov 30, 2022: Optinose announces corporate updates and Presentation at the 34th Annual Piper Sandler Healthcare Conference 263

6.13 Nov 30, 2022: Recipharm invests in its single dose nasal platform capabilities 264

6.14 Nov 22, 2022: Distinguished Cancer and Stem Cell Biologist Ulrich Steidl M.D. Ph.D. Appointed Chair of Cell Biology at Albert Einstein College of Medicine 265

6.15 Nov 14, 2022: AcelRx Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update 266

6.16 Nov 10, 2022: Dare Bioscience Reports Third Quarter 2022 Financial Results and Provides a Company Update 266

6.17 Nov 10, 2022: Aptar Mumbai announces new facility construction 269

6.18 Nov 04, 2022: Avanir files WARN notice for 100+ layoffs from California as merger with parent Otsuka looms 270

6.19 Nov 01, 2022: Cognitive Research Corp. Appoints Jeff Williams as Executive Chairman Following Growth Equity Transaction 270

6.20 Nov 01, 2022: New study confirms ColdZyme stops viruses causing Covid-19 from adhering to human respiratory cells 271

6.21 Oct 31, 2022: Aptar Pharma completes first phase of global injectables expansion program 271

6.22 Oct 18, 2022: Aptar Digital Health announces strategic partnership with the Chiesi Group 272

6.23 Oct 11, 2022: Aptar Digital Health launches new disease management platform 273

6.24 Aug 15, 2022: Impel Pharmaceuticals Announces Second Quarter 2022 Financial Results and Provides Corporate Update 274

6.25 Aug 12, 2022: AcelRx Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update 275

6.26 Jul 28, 2022: Cosmo reports strong half-year 2022 financial results delivering record revenues and reaffirms 2022 full-year guidance 277

6.27 Jul 13, 2022: Sonoma Pharmaceuticals Reports Fiscal Year and Fourth Quarter 2022 Financial Results 279

6.28 Jul 12, 2022: Aspire & USF Pass $10M in ticket & donation revenue 280

7 Appendix 281

7.1 Methodology 281

7.2 About GlobalData 284

7.3 Contact Us 284

7.4 Disclaimer 284

Table

Transmucosal Drug Delivery – Pipeline Products by Stage of Development 21

Transmucosal Drug Delivery – Pipeline Products by Segment 22

Transmucosal Drug Delivery – Pipeline Products by Territory 23

Transmucosal Drug Delivery – Pipeline Products by Regulatory Path 25

Transmucosal Drug Delivery – Pipeline Products by Estimated Approval Date 26

Transmucosal Drug Delivery – Ongoing Clinical Trials 27

Transmucosal Drug Delivery Companies – Pipeline Products by Stage of Development 28

Transmucosal Drug Delivery – Pipeline Products by Stage of Development 33

AcelRx Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 37

Zalviso – Product Status 37

Zalviso – Product Description 38

AcelRx Pharmaceuticals Inc – Ongoing Clinical Trials Overview 39

Zalviso – Treatment of Acute Post-operative Pain in Patients Undergoing Laparoscopic Colon Resections 40

AFYX Therapeutics A/S Pipeline Products & Ongoing Clinical Trials Overview 41

Rivelin – CLO Patch – Product Status 41

Rivelin – CLO Patch – Product Description 41

Albert Einstein College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 42

Drug-Impregnated Intravaginal Ring – Product Status 42

Drug-Impregnated Intravaginal Ring – Product Description 42

Allergan Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

Vaginal Ring – Product Status 43

Vaginal Ring – Product Description 43

Altamira Medica AG Pipeline Products & Ongoing Clinical Trials Overview 44

Bentrio – Viral Infections – Product Status 44

Bentrio – Viral Infections – Product Description 44

Altamira Medica AG – Ongoing Clinical Trials Overview 45

Bentrio – Viral Infections – A Randomized, Placebo-controlled Clinical Study to Evaluate the Ability of Bentrio Nasal Spray in COVID-19 Patients: COVAMID 46

Bentrio – Viral Infections – Study Evaluating the Efficacy of Bentrio Nasal Spray for Protection Against Airborne Viruses and Allergens in India 46

Anelleo Inc Pipeline Products & Ongoing Clinical Trials Overview 47

AnelleO PRO – Product Status 47

AnelleO PRO – Product Description 47

Aquestive Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 48

Anaphylm – Product Status 48

Anaphylm – Product Description 48

Arovella Therapeutics Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

ArTiMist – Product Status 49

ArTiMist – Product Description 49

ARS Pharmaceuticals, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50

Neffy – Product Status 50

Neffy – Product Description 50

Atossa Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 51

AT-301 Nasal Spray – Product Status 51

AT-301 Nasal Spray – Product Description 51

Auris Medical AG Pipeline Products & Ongoing Clinical Trials Overview 52

AM-125 Betahistine Nasal Spray – Product Status 52

AM-125 Betahistine Nasal Spray – Product Description 52

AM-201 Betahistine Nasal Spray – Product Status 53

AM-201 Betahistine Nasal Spray – Product Description 53

Auritec Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 54

BUP Pod-IVR – Product Status 54

BUP Pod-IVR – Product Description 55

NuvaRing – Product Status 55

NuvaRing – Product Description 55

pod-IVR – Product Status 56

pod-IVR – Product Description 56

Versa Intravaginal Ring – Acromegaly – Product Status 56

Versa Intravaginal Ring – Acromegaly – Product Description 57

Versa Intravaginal Ring – Alzheimer’s Disease – Product Status 57

Versa Intravaginal Ring – Alzheimer’s Disease – Product Description 57

Versa Intravaginal Ring – Breast Cancer – Product Status 58

Versa Intravaginal Ring – Breast Cancer – Product Description 58

Versa Intravaginal Ring – Endometriosis – Product Status 58

Versa Intravaginal Ring – Endometriosis – Product Description 59

Versa Intravaginal Ring – Herpes – Product Status 59

Versa Intravaginal Ring – Herpes – Product Description 59

Versa Intravaginal Ring – HIV Prophylaxis – Product Status 60

Versa Intravaginal Ring – HIV Prophylaxis – Product Description 60

Versa Intravaginal Ring – Pain And Addiction – Product Status 60

Versa Intravaginal Ring – Pain And Addiction – Product Description 61

Versa Intravaginal Ring – Parkinson’s Disease – Product Status 61

Versa Intravaginal Ring – Parkinson’s Disease – Product Description 61

Versa Intravaginal Ring – Type II Diabetes – Product Status 62

Versa Intravaginal Ring – Type II Diabetes – Product Description 62

Versa Intravaginal Ring – Uterine Fibroids – Product Status 62

Versa Intravaginal Ring – Uterine Fibroids – Product Description 63

BeFree! Pipeline Products & Ongoing Clinical Trials Overview 64

Vaginal Drug Delivery System – Product Status 64

Vaginal Drug Delivery System – Product Description 64

Bespak Europe Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

NAS010 – Nasal Drug Delivery Device – Product Status 65

NAS010 – Nasal Drug Delivery Device – Product Description 65

NAS020 – Unidose Nasal Drug Delivery Device – Product Status 66

NAS020 – Unidose Nasal Drug Delivery Device – Product Description 66

NAS030 Nasal Device – Product Status 66

NAS030 Nasal Device – Product Description 66

Biorings LLC Pipeline Products & Ongoing Clinical Trials Overview 67

Vaginal Ring – Product Status 67

Vaginal Ring – Product Description 67

BioXcel Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 68

BXCL501 Sublingual Film – Product Status 68

BXCL501 Sublingual Film – Product Description 69

BioXcel Therapeutics Inc – Ongoing Clinical Trials Overview 70

BXCL501 Sublingual Film – A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects with Agitation Associated with Dementia 71

BXCL501 Sublingual Film – A Study to Evaluate the BXCL501 for At-home Use in Patients with Bipolar Disorder or Schizophrenia 71

Birmingham Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

BHM Anti-Viral Nasal Spray – Product Status 72

BHM Anti-Viral Nasal Spray – Product Description 72

Bryn Pharma LLC Pipeline Products & Ongoing Clinical Trials Overview 73

BRYN-NDS1C – Product Status 73

BRYN-NDS1C – Product Description 73

Callitas Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 74

CannaMint Strip – Product Status 74

CannaMint Strip – Product Description 74

Chulalongkorn University Pipeline Products & Ongoing Clinical Trials Overview 75

AntiCov Nasal Spray – Product Status 75

AntiCov Nasal Spray – Product Description 75

Combinent BioMedical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 76

Multi-Segmented Vaginal Ring – Product Status 76

Multi-Segmented Vaginal Ring – Product Description 76

Conrad Pipeline Products & Ongoing Clinical Trials Overview 77

Topical Dual-Compartment Insert – Product Status 77

Topical Dual-Compartment Insert – Product Description 77

Triple Protection Vaginal Ring – Product Status 78

Triple Protection Vaginal Ring – Product Description 78

Vaginal Ring – HIV Protection – Product Status 78

Vaginal Ring – HIV Protection – Product Description 79

Covidrops LLP Pipeline Products & Ongoing Clinical Trials Overview 80

Nasal Spray – COVID-19 – Product Status 80

Nasal Spray – COVID-19 – Product Description 80

Dare Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 81

DARE-FRT1 Intravaginal Ring – Product Status 81

DARE-FRT1 Intravaginal Ring – Product Description 81

DARE-HRT1 Intravaginal Ring – Product Status 82

DARE-HRT1 Intravaginal Ring – Product Description 82

DARE-OAB1 – Product Status 82

DARE-OAB1 – Product Description 83

DARE-VVA1 Intravaginal Ring – Product Status 83

DARE-VVA1 Intravaginal Ring – Product Description 83

Dare Bioscience Inc – Ongoing Clinical Trials Overview 84

DARE-HRT1 Intravaginal Ring – A Phase 1/2, Open-label, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of DARE-HRT1 (80ug Estradiol/4 Mg Progesterone and 160ug Estradiol/8 Mg Progesterone Intravaginal Rings) Over 12 Weeks in Healthy Postmenopausal Women 85

Eledon Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 86

OP0201 – Product Status 86

OP0201 – Product Description 86

Emergent BioSolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 87

SIAN – Product Status 87

SIAN – Product Description 87

Emergent BioSolutions Inc – Ongoing Clinical Trials Overview 88

SIAN – Phase 1, Open Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Stabilized Isoamyl Nitrite (SIAN) Nasal Spray in Healthy Adults 89

EmphyCorp Inc Pipeline Products & Ongoing Clinical Trials Overview 90

N115 Non-Steroidal Nasal Spray – Product Status 90

N115 Non-Steroidal Nasal Spray – Product Description 90

Ena Respiratory Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

INNA-051 Nasal Spray – Product Status 91

INNA-051 Nasal Spray – Product Description 91

Ena Respiratory Pty Ltd – Ongoing Clinical Trials Overview 92

INNA-051 Nasal Spray – A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending, Intranasal INNA-051 Doses in Healthy Adults 93

Eureka Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 94

InvisiMask Nasal Spray – Product Status 94

InvisiMask Nasal Spray – Product Description 94

Eveon SAS Pipeline Products & Ongoing Clinical Trials Overview 95

Dropper System – Product Status 95

Dropper System – Product Description 95

Evestra Inc Pipeline Products & Ongoing Clinical Trials Overview 96

EVE112 – Vaginal Ring – Product Status 96

EVE112 – Vaginal Ring – Product Description 96

EVE116 – Vaginal Ring – Product Status 97

EVE116 – Vaginal Ring – Product Description 97

EVE120 – Vaginal Ring – Product Status 97

EVE120 – Vaginal Ring – Product Description 98

EVE122 – Vaginal Ring – Product Status 98

EVE122 – Vaginal Ring – Product Description 98

Vaginal Ring For Preterm Labor – Product Status 99

Vaginal Ring For Preterm Labor – Product Description 99

Evofem Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 100

Amphora/QGriffithsin Fast-Dissolving Vaginal Insert – Product Status 100

Amphora/QGriffithsin Fast-Dissolving Vaginal Insert – Product Description 101

Ferring Pharmaceuticals AS Pipeline Products & Ongoing Clinical Trials Overview 102

C-Vad Vaginal Insert – Product Status 102

C-Vad Vaginal Insert – Product Description 102

Premis Vaginal Insert – Product Status 103

Premis Vaginal Insert – Product Description 103

Firebrick Pharma Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 104

Nasodine Nasal Spray – Adult – Product Status 104

Nasodine Nasal Spray – Adult – Product Description 104

Nasodine Nasal Spray – Junior – Product Status 105

Nasodine Nasal Spray – Junior – Product Description 105

Firebrick Pharma Pty Ltd – Ongoing Clinical Trials Overview 106

Nasodine Nasal Spray – Adult – Confirmatory Phase III study of Nasodine Nasal Spray (Povidone-iodine 0.5%) as a Symptomatic Treatment for Early Stage Common Cold in the Natural Setting 107

Nasodine Nasal Spray – Adult – Reduction of Nasal Shedding of SARS-CoV-2 in COVID-19 Positive Patients by the Use of Nasodine (Povidone-iodine 0.5%) Nasal Spray 107

GeneOne Life Science Inc Pipeline Products & Ongoing Clinical Trials Overview 108

GLS-1200 Nasal Spray – Product Status 108

GLS-1200 Nasal Spray – Product Description 108

Ghent University Pipeline Products & Ongoing Clinical Trials Overview 109

Vaginal DL-Lactic Acid Releasing Ring – Product Status 109

Vaginal DL-Lactic Acid Releasing Ring – Product Description 109

Glenmark Pharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

Ryaltris Nasal Spray – Product Status 111

Ryaltris Nasal Spray – Product Description 111

Glenmark Pharmaceuticals Ltd – Ongoing Clinical Trials Overview 112

Ryaltris Nasal Spray – A Phase III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ryaltris Compound Nasal Spray for the Treatment of Allergic Rhinitis or Rhinoconjunctivitis Symptoms in Patients 113

Grasses of Eden Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

Nasal Spray Device – Product Status 114

Nasal Spray Device – Product Description 114

Grasses of Eden Ltd – Ongoing Clinical Trials Overview 115

Nasal Spray Device – A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Lavandula Angustifolia Containing Nasal Spray Medical Device in Preventing Deterioration of COVID-19 in Symptomatic Patients 116

Grunenthal Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

Estradiol + Progesterone Vaginal Ring – Product Status 117

Estradiol + Progesterone Vaginal Ring – Product Description 117

Fertiring – Product Status 118

Fertiring – Product Description 118

Halberd Corp Pipeline Products & Ongoing Clinical Trials Overview 119

Halberd Nasal Spray – Product Status 119

Halberd Nasal Spray – Product Description 119

Harm Reduction Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 120

Rivive – Product Status 120

Rivive – Product Description 120

Hebrew University of Jerusalem Pipeline Products & Ongoing Clinical Trials Overview 121

Buccal Drug Delivery Device – Oral Cavity Disorders – Product Status 121

Buccal Drug Delivery Device – Oral Cavity Disorders – Product Description 121

Hikma Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 122

Buprenorphine/Naloxone Sublingual Spray – Product Status 122

Buprenorphine/Naloxone Sublingual Spray – Product Description 122

EpiPen – Product Status 123

EpiPen – Product Description 123

Imbed Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 124

Nasal Spray – Product Status 124

Nasal Spray – Product Description 124

Institute for Research and Innovation in Health Pipeline Products & Ongoing Clinical Trials Overview 125

TFV/EFV Nanoparticle Vaginal Delivery System – Product Status 125

TFV/EFV Nanoparticle Vaginal Delivery System – Product Description 125

Insys Therapeutics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 126

Buprenorphine Sublingual Spray Device – Product Status 126

Buprenorphine Sublingual Spray Device – Product Description 126

Naloxone Sublingual Spray – Product Status 127

Naloxone Sublingual Spray – Product Description 127

Ondansetron Sublingual Spray – Product Status 127

Ondansetron Sublingual Spray – Product Description 127

IntelGenx Corp Pipeline Products & Ongoing Clinical Trials Overview 128

Montelukast VersaFilm – Product Status 128

Montelukast VersaFilm – Product Description 128

IntelGenx Corp – Ongoing Clinical Trials Overview 129

Montelukast VersaFilm – A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Use of Montelukast Versafilm for the Treatment of Parkinson’s Disease (PD) 130

Montelukast VersaFilm – A Randomized Phase IIa, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety, Feasibility, Tolerability, and Efficacy of a New Buccal Film of Montelukast in Patients with Mild to Moderate Alzheimer’s Disease 130

International Partnership For Microbicides Pipeline Products & Ongoing Clinical Trials Overview 131

Dapivirine-Contraceptive Ring – Product Status 131

Dapivirine-Contraceptive Ring – Product Description 131

International Partnership For Microbicides – Ongoing Clinical Trials Overview 132

Dapivirine-Contraceptive Ring – A Phase I, Open-label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 Mg Dapivirine Vaginal Ring 004 Inserted Every 30 Days and the 100 Mg Dapivirine Vaginal Ring 008 Inserted for 90 Days in Healthy Female Participants 133

Dapivirine-Contraceptive Ring – A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated With 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel 133

ITC Life Sciences and Technology Centre Pipeline Products & Ongoing Clinical Trials Overview 134

Savlon Nasal Spray – Product Status 134

Savlon Nasal Spray – Product Description 134

ITF Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 135

Progesterone Vaginal Ring – Luteal Support – Product Status 135

Progesterone Vaginal Ring – Luteal Support – Product Description 135

Janssen Sciences Ireland UC Pipeline Products & Ongoing Clinical Trials Overview 136

Dapivirine Ring – Product Status 136

Dapivirine Ring – Product Description 136

Janssen Sciences Ireland UC – Ongoing Clinical Trials Overview 137

Dapivirine Ring – Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA Use in Pregnancy 138

Kane Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 139

Nasal Spray – Chronic Sinusitis – Product Status 139

Nasal Spray – Chronic Sinusitis – Product Description 139

Karessa Pharma AB Pipeline Products & Ongoing Clinical Trials Overview 140

K-01 – Product Status 140

K-01 – Product Description 140

K-02 – Product Status 141

K-02 – Product Description 141

K-03 – Product Status 141

K-03 – Product Description 142

K-21 – Product Status 142

K-21 – Product Description 142

Karp Lab Pipeline Products & Ongoing Clinical Trials Overview 143

Nasal Spray – SARS-CoV-2 – Product Status 143

Nasal Spray – SARS-CoV-2 – Product Description 143

Kiora Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 144

EyeGate II Delivery System – Product Status 144

EyeGate II Delivery System – Product Description 145

Kytogenics Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 146

Drug Delivery Device – Intestinal Cystitis – Product Status 146

Drug Delivery Device – Intestinal Cystitis – Product Description 146

Laboratoire HRA Pharma SAS Pipeline Products & Ongoing Clinical Trials Overview 147

UPA – CVR – Product Status 147

UPA – CVR – Product Description 147

Lachesis Biosciences Ltd Pipeline Products & Ongoing Clinical Trials Overview 148

Rivamist Nasal Spray – Product Status 148

Rivamist Nasal Spray – Product Description 148

Leyden Laboratories BV Pipeline Products & Ongoing Clinical Trials Overview 149

Liquid Nasal Spray – Product Status 149

Liquid Nasal Spray – Product Description 149

Lobe Sciences Ltd Pipeline Products & Ongoing Clinical Trials Overview 150

Nasal Mist Device – Product Status 150

Nasal Mist Device – Product Description 150

Lyra Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 151

LYR-210 Transmucosal Delivery System – Product Status 151

LYR-210 Transmucosal Delivery System – Product Description 151

LYR-220 – Product Status 152

LYR-220 – Product Description 152

Lyra Therapeutics Inc – Ongoing Clinical Trials Overview 153

LYR-210 Transmucosal Delivery System – ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults 154

LYR-210 Transmucosal Delivery System – ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults 154

LYR-220 – BEACON: A Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220 in Chronic Rhinosinusitis (CRS) Patients Who Have Had a Prior Ethmoidectomy 155

Magee-Womens Research Institute Pipeline Products & Ongoing Clinical Trials Overview 156

EFdA-P+Progestin Intravaginal Film – Product Status 156

EFdA-P+Progestin Intravaginal Film – Product Description 156

MassBiologics Pipeline Products & Ongoing Clinical Trials Overview 157

mAb 2C7+TDF IVR – Product Status 157

mAb 2C7+TDF IVR – Product Description 157

McNeil AB Pipeline Products & Ongoing Clinical Trials Overview 158

Antiviral Polymeric Nasal Spray – Product Status 158

Antiviral Polymeric Nasal Spray – Product Description 158

Medlab Clinical Ltd Pipeline Products & Ongoing Clinical Trials Overview 159

NanaBis – Product Status 159

NanaBis – Product Description 159

Medlab Clinical Ltd – Ongoing Clinical Trials Overview 160

NanaBis – An Observational Study Investigating and Auditing the Safety, Tolerability and Further Efficacy Characteristics of a Pharmaceutical Grade Cannabis Medicine (NanaBis) Prescribed to Eligible Patients for the Management of Cancer Related or Non-cancer Related Pain in General and Specialty Medical Practices 161

Merck & Co Inc Pipeline Products & Ongoing Clinical Trials Overview 162

ENG-CVR – Product Status 162

ENG-CVR – Product Description 162

Merck Serono SA Pipeline Products & Ongoing Clinical Trials Overview 163

MK-8342 Medicated IUS – Product Status 163

MK-8342 Medicated IUS – Product Description 163

Mucommune LLC Pipeline Products & Ongoing Clinical Trials Overview 164

HCA+VRC01+N6 IVR – Product Status 164

HCA+VRC01+N6 IVR – Product Description 164

LA-Releasing Intravaginal Ring – Product Status 165

LA-Releasing Intravaginal Ring – Product Description 165

Non-Hormonal Contraceptive Intravaginal Ring – Product Status 165

Non-Hormonal Contraceptive Intravaginal Ring – Product Description 166

Mycrodose Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 167

Sublingual Drug Delivery System – LSD – Product Status 167

Sublingual Drug Delivery System – LSD – Product Description 167

Mystic Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 168

MystiFen – Product Status 168

MystiFen – Product Description 168

MystiZof – Product Status 169

MystiZof – Product Description 169

Nanosys Inc Pipeline Products & Ongoing Clinical Trials Overview 170

Gecko-Inspired Drug Delivery Device – Product Status 170

Gecko-Inspired Drug Delivery Device – Product Description 170

Nasus Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 171

Catheter-Based Atomization Drug Delivery Device – Product Status 171

Catheter-Based Atomization Drug Delivery Device – Product Description 171

Nasus Pharma Ltd Pipeline Products & Ongoing Clinical Trials Overview 172

FMXIN001 Naloxone Powder-Based Nasal Spray – Product Status 172

FMXIN001 Naloxone Powder-Based Nasal Spray – Product Description 172

Nemera La Verpilliere Pipeline Products & Ongoing Clinical Trials Overview 173

Electronic Nasal Device – Product Status 173

Electronic Nasal Device – Product Description 173

NorInvent AB Pipeline Products & Ongoing Clinical Trials Overview 174

XtriG Drug Delivery Device – Product Status 174

XtriG Drug Delivery Device – Product Description 174

Novlead Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 175

iNOfirst Antiviral Spray – Product Status 175

iNOfirst Antiviral Spray – Product Description 175

Olfax LLC Pipeline Products & Ongoing Clinical Trials Overview 176

Intranasal Delivery Device – Product Status 176

Intranasal Delivery Device – Product Description 176

Opiant Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 177

OPNT001 Opioid Antagonist Nasal Spray – Product Status 177

OPNT001 Opioid Antagonist Nasal Spray – Product Description 177

OPNT002 Opioid Antagonist Nasal Spray – Product Status 178

OPNT002 Opioid Antagonist Nasal Spray – Product Description 178

Opiant Pharmaceuticals Inc – Ongoing Clinical Trials Overview 179

OPNT002 Opioid Antagonist Nasal Spray – Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Naltrexone Hydrochloride Nasal Spray on Alcohol Consumption in Alcohol Usse Disorder 180

OptiNose AS Pipeline Products & Ongoing Clinical Trials Overview 181

OptiNose Bi-Directional Breath Powered Orexin-A Delivery Device – Product Status 181

OptiNose Bi-Directional Breath Powered Orexin-A Delivery Device – Product Description 181

XHANCE – Product Status 182

XHANCE – Product Description 182

OptiNose AS – Ongoing Clinical Trials Overview 183

XHANCE – 16-Week Randomized Double-blind Placebo Controlled Parallel-Group Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 µg Twice a Day in Adolescents with Bilateral Nasal Polyps Followed with 12-Week Open-label Treatment Phase 184

OptiNose Inc Pipeline Products & Ongoing Clinical Trials Overview 185

Optinose Exhalation Delivery Device – Product Status 185

Optinose Exhalation Delivery Device – Product Description 185

Organon Pharma (UK) Ltd Pipeline Products & Ongoing Clinical Trials Overview 186

Etonogestrel + 17ß-Estradiol Vaginal Ring – Product Status 186

Etonogestrel + 17ß-Estradiol Vaginal Ring – Product Description 186

Orion Biotechnology Canada Ltd Pipeline Products & Ongoing Clinical Trials Overview 187

OB-002 IVR – Product Status 187

OB-002 IVR – Product Description 187

Orphanse Healthcare SAS Pipeline Products & Ongoing Clinical Trials Overview 188

ORH01 Drug Delivery Device – Product Status 188

ORH01 Drug Delivery Device – Product Description 188

Oyster Point Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 189

Tyrvaya Nasal Spray – Product Status 189

Tyrvaya Nasal Spray – Product Description 189

P&B Group Pipeline Products & Ongoing Clinical Trials Overview 190

ADW S-100 Ionized Water Nasal Spray – Product Status 190

ADW S-100 Ionized Water Nasal Spray – Product Description 190

P&B Group – Ongoing Clinical Trials Overview 191

ADW S-100 Ionized Water Nasal Spray – Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis: Randomized, Double-blind, Placebo-controlled Trial 192

Palette Life Sciences AB Pipeline Products & Ongoing Clinical Trials Overview 193

Lidbree – Product Status 193

Lidbree – Product Description 193

Parnell Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 194

Nomovid Nasal Spray – Product Status 194

Nomovid Nasal Spray – Product Description 194

Phoenix Life Sciences International Ltd Pipeline Products & Ongoing Clinical Trials Overview 195

Phoenix Neuro – Product Status 195

Phoenix Neuro – Product Description 195

Phoenix Pain – Product Status 196

Phoenix Pain – Product Description 196

PHOENIX Sport Plus – Product Status 196

PHOENIX Sport Plus – Product Description 197

pHOXBIO Ltd Pipeline Products & Ongoing Clinical Trials Overview 198

pHOXWELL – Product Status 198

pHOXWELL – Product Description 198

pHOXBIO Ltd – Ongoing Clinical Trials Overview 199

pHOXWELL – A Phase I Study to Evaluate the Safety of pHOXWELL Nasal Spray in the Prevention of SARS-CoV-2 Infection 200

Pocket Naloxone Corp Pipeline Products & Ongoing Clinical Trials Overview 201

Intranasal Spray – Naloxone – Product Status 201

Intranasal Spray – Naloxone – Product Description 201

Polyrizon Ltd Pipeline Products & Ongoing Clinical Trials Overview 202

Intranasal Delivery System – Product Status 202

Intranasal Delivery System – Product Description 202

RDD Pharma Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 203

Capository – Product Status 203

Capository – Product Description 203

Receptor Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 204

RLS103 – Product Status 204

RLS103 – Product Description 204

Renown Pharmaceuticals Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 205

Sub-Lingual Apomorphine Spray – Product Status 205

Sub-Lingual Apomorphine Spray – Product Description 205

Rhinomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 206

Intranasal Drug Delivery Device – Acute Migraine – Product Status 206

Intranasal Drug Delivery Device – Acute Migraine – Product Description 206

Sanotize Research and Development Corp Pipeline Products & Ongoing Clinical Trials Overview 207

Fabispray – Product Status 207

Fabispray – Product Description 207

Sanotize Research and Development Corp – Ongoing Clinical Trials Overview 208

Fabispray – A Double-blinded, Placebo-controlled Parallel, Phase 3 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) to Treat and Prevent the Exacerbation of Infection in Individuals with Documented Asymptomatic or Mild COVID-19 209

Fabispray – A Phase III Study of SaNOtize Nitric Oxide Nasal Spray for the Early Treatment of Patients with COVID-19 and Its Variants 209

Scientus Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 210

RapidMist Buccal Delivery System – Product Status 210

RapidMist Buccal Delivery System – Product Description 210

Seelos Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 211

SLS-002 Intranasal Device – Product Status 211

SLS-002 Intranasal Device – Product Description 211

Seelos Therapeutics, Inc. – Ongoing Clinical Trials Overview 212

SLS-002 Intranasal Device – A 2-part Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) Administered to Adults with Major Depressive Disorder at Imminent Risk of Suicide 213

Shin Nippon Biomedical Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 214

µco System – Product Status 214

µco System – Product Description 214

SipNose Ltd Pipeline Products & Ongoing Clinical Trials Overview 215

Cribriform Targeted Device – Product Status 215

Cribriform Targeted Device – Product Description 216

South Valley University Pipeline Products & Ongoing Clinical Trials Overview 217

Ivermectin Nasal Spray – Product Status 217

Ivermectin Nasal Spray – Product Description 217

Starpharma Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 218

Viraleze Nasal Spray – Product Status 218

Viraleze Nasal Spray – Product Description 218

The Population Council Inc Pipeline Products & Ongoing Clinical Trials Overview 219

EEQ Intravaginal Ring – Product Status 219

EEQ Intravaginal Ring – Product Description 219

Therakind Ltd Pipeline Products & Ongoing Clinical Trials Overview 220

DriDose – Product Status 220

DriDose – Product Description 220

Union Therapeutics AS Pipeline Products & Ongoing Clinical Trials Overview 221

Niclosamide Nasal Spray – Product Status 221

Niclosamide Nasal Spray – Product Description 221

University of California Davis Pipeline Products & Ongoing Clinical Trials Overview 222

Copper Intravaginal Ring (Cu-IVR) – Product Status 222

Copper Intravaginal Ring (Cu-IVR) – Product Description 222

University of Erlangen-Nurnberg Pipeline Products & Ongoing Clinical Trials Overview 223

Carragelose Nasal Spray – Product Status 223

Carragelose Nasal Spray – Product Description 223

University of Kentucky Pipeline Products & Ongoing Clinical Trials Overview 224

Povidone-Iodine Nasal Spray – Product Status 224

Povidone-Iodine Nasal Spray – Product Description 224

University of Kentucky – Ongoing Clinical Trials Overview 225

Povidone-Iodine Nasal Spray – Povidone-Iodine Intranasal for Prophylaxis in Front-line Health-care Personnel and Inpatients During the Sars-CoV-2 Pandemic 226

University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 227

Q-Griffithsin Nasal Spray – Product Status 227

Q-Griffithsin Nasal Spray – Product Description 227

University of Melbourne Pipeline Products & Ongoing Clinical Trials Overview 228

At-Home Nasal Spray – COVID-19 – Product Status 228

At-Home Nasal Spray – COVID-19 – Product Description 228

University of Melbourne – Ongoing Clinical Trials Overview 229

At-Home Nasal Spray – COVID-19 – Study to Evaluate the Efficacy of At-Home Nasal Spray – COVID-19 in Patients with COVID-19 230

University of North Carolina at Chapel Hill Pipeline Products & Ongoing Clinical Trials Overview 231

Dapivirine + Pritelivir + Levonorgestrel 3D Printed IVR – Product Status 231

Dapivirine + Pritelivir + Levonorgestrel 3D Printed IVR – Product Description 231

Islatravir+Etonogestrel/Ethinyl Estradiol 3D Printed IVR – Product Status 232

Islatravir+Etonogestrel/Ethinyl Estradiol 3D Printed IVR – Product Description 232

University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 233

HerShield – Product Status 233

HerShield – Product Description 233

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 234

Drug Delivery Device – Ovarian Cancer – Product Status 234

Drug Delivery Device – Ovarian Cancer – Product Description 234

University of Texas at Austin Pipeline Products & Ongoing Clinical Trials Overview 235

Transmucosal Patch – Product Status 235

Transmucosal Patch – Product Description 235

University of the Witwatersrand Pipeline Products & Ongoing Clinical Trials Overview 236

Vagitab – Product Status 236

Vagitab – Product Description 236

University of Waterloo Pipeline Products & Ongoing Clinical Trials Overview 237

HIV Prevention Device – Product Status 237

HIV Prevention Device – Product Description 237

Virpax Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 238

AnQlar – Product Status 238

AnQlar – Product Description 238

MMS019 – Product Status 239

MMS019 – Product Description 239

VistaGen Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 240

PH10 Nasa

Figures

Transmucosal Drug Delivery – Pipeline Products by Stage of Development 20

Transmucosal Drug Delivery – Pipeline Products by Segment 21

Transmucosal Drug Delivery – Pipeline Products by Territory 22

Transmucosal Drug Delivery – Pipeline Products by Regulatory Path 24

Transmucosal Drug Delivery – Pipeline Products by Estimated Approval Date 25

Transmucosal Drug Delivery – Ongoing Clinical Trials 26

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