Inhalers Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Inhalers Pipeline Market Report Overview

Inhalers deliver medication to the lungs. The inhalers pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Segment ·        Dry Powder Inhaler Devices
Key Territories ·        The US

·        Europe

·        Australia

·        Israel

·        China

Key Regulatory Paths ·        510(k)

·        CE

·        TGA

·        NMPA

·        Ninsho

Leading Companies ·        Acorda Therapeutics Inc

·        Advent Pharmaceuticals Pty Ltd

·        Cambridge Healthcare Innovations Ltd

·        Cipla Ltd

·        Drexel University

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Inhalers Pipeline Market by Segments

The only segment in the inhalers pipeline market is the dry powder inhaler.

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Inhalers Pipeline Market Segmentation by Territories

A few of the key territories for the inhalers pipeline market are the US, Europe, China, Australia, and Israel among others. As of December 2023, the US accounted for the highest number of pipeline products.

Inhalers Pipeline Market Analysis by Territories, 2023 (%)

Inhalers Pipeline Market Analysis by Territories, 2023 (%)

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Inhalers Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the inhalers pipeline market are 510(k), CE, TGA, NMPA, and Ninsho among others. As of December 2023, 510(k) was the most followed pathway for pipeline products in the market.

Inhalers Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Inhalers Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Inhalers Pipeline Market – Competitive Landscape

A few of the key companies associated with the inhalers pipeline market are Acorda Therapeutics Inc, Advent Pharmaceuticals Pty Ltd, Cambridge Healthcare Innovations Ltd, Cipla Ltd, and Drexel University among others.

Acorda Therapeutics Inc: Acorda is headquartered in Ardsley, New York, the US. The company is a biopharmaceutical company that discovers, develops, and markets therapies for treating patients with neurological disorders.

Advent Pharmaceuticals Pty Ltd: Advent Pharmaceuticals Pty Ltd is headquartered in Australia. The company is a pharmaceutical company that develops, registers, and manufactures inhaled medicines.

Inhalers Pipeline Market Analysis by Companies, 2023

Inhalers Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Inhalers Pipeline Market Segments Outlook

  • Dry Powder Inhaler Devices

Inhalers Pipeline Market Territories Outlook

  • The US
  • Europe
  • Australia
  • Israel

Inhalers Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE
  • TGA
  • NMPA

Scope

This report provides:

  • Extensive coverage of the inhalers under development.
  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of Inhalers and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

The report will enable 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 inhalers under development.
  • Develop market-entry and market-expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • Carry out In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

1nhaler Ltd
Acorda Therapeutics Inc
Advent Pharmaceuticals Pty Ltd
Aerami Therapeutics Inc
Aespira Ltd.
AKELA Pharma Inc. (Inactive)
AsMedic Ltd.
Bayer AG
Bellerophon Therapeutics Inc
Cambridge Healthcare Innovations Ltd
Cipla Ltd
Covinhaler LLP
Creare LLC
De Motu Cordis Pty Ltd
DMK Pharmaceuticals Corp
Drexel University
Eli Lilly and Co
Engage Therapeutics Inc
Findair Sp zoo
FocusStart LLC
Glenmark Pharmaceuticals Ltd
GSK plc
Hovione Technology Ltd
Iconovo AB
Lupin Pharmaceuticals Inc
MannKind Corp
Medihale Ltd (Inactive)
Monash University
Nektar Therapeutics
North Carolina State University
Novartis AG
Ology Bioservices Inc
OPKO Health Inc
OtiTopic Inc
Pai Life Sciences Inc
Phargentis SA
Pharmaxis Ltd
Pneuma Respiratory Inc
Pure Scientific Technologies Inc
PureIMS BV
Quench Medical Inc
Resolve Digital Health Inc
Respira Therapeutics Inc
Respirent Pharmaceuticals Co Ltd
Rhinomed Ltd
Sandoz International GmbH
Seng Vital International GmbH
Sheffield Hallam University
Shin Nippon Biomedical Laboratories Ltd
Sinsin Pharmaceutical Co Ltd
Softhale NV
Spyryx Biosciences Inc (Inactive)
Teva Pharmaceutical Industries Ltd
Transpire Bio Inc
University of Kansas
University of Sydney
University of Texas Medical Branch at Galveston
Uscom Ltd
Vectura Group Plc
Veoli Ltd
Verona Pharma Plc
Virginia Commonwealth University

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 8

|1.2 List of Figures 14

2 Introduction 15

2.1 Inhalers Overview 15

3 Products under Development 16

3.1 Inhalers – Pipeline Products by Stage of Development 16

3.2 Inhalers – Pipeline Products by Segment 17

3.3 Inhalers – Pipeline Products by Territory 18

3.4 Inhalers – Pipeline Products by Regulatory Path 20

3.5 Inhalers – Pipeline Products by Estimated Approval Date 21

3.6 Inhalers – Ongoing Clinical Trials 22

4 Inhalers – Pipeline Products under Development by Companies 23

4.1 Inhalers Companies – Pipeline Products by Stage of Development 23

4.2 Inhalers – Pipeline Products by Stage of Development 26

5 Inhalers Companies and Product Overview 29

5.1 1nhaler Ltd Company Overview 29

5.1.1 1nhaler Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

5.2 Acorda Therapeutics Inc Company Overview 30

5.2.1 Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.3 Advent Pharmaceuticals Pty Ltd Company Overview 34

5.3.1 Advent Pharmaceuticals Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 34

5.4 Aerami Therapeutics Inc Company Overview 35

5.4.1 Aerami Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.5 Aespira Ltd. Company Overview 36

5.5.1 Aespira Ltd. Pipeline Products & Ongoing Clinical Trials Overview 36

5.6 AKELA Pharma Inc. (Inactive) Company Overview 37

5.6.1 AKELA Pharma Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 37

5.7 AsMedic Ltd. Company Overview 38

5.7.1 AsMedic Ltd. Pipeline Products & Ongoing Clinical Trials Overview 38

5.8 Bayer AG Company Overview 39

5.8.1 Bayer AG Pipeline Products & Ongoing Clinical Trials Overview 39

5.9 Bellerophon Therapeutics Inc Company Overview 41

5.9.1 Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.10 Cambridge Healthcare Innovations Ltd Company Overview 42

5.10.1 Cambridge Healthcare Innovations Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

5.11 Cipla Ltd Company Overview 43

5.11.1 Cipla Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

5.12 Covinhaler LLP Company Overview 45

5.12.1 Covinhaler LLP Pipeline Products & Ongoing Clinical Trials Overview 45

5.13 Creare LLC Company Overview 46

5.13.1 Creare LLC Pipeline Products & Ongoing Clinical Trials Overview 46

5.14 De Motu Cordis Pty Ltd Company Overview 47

5.14.1 De Motu Cordis Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

5.15 DMK Pharmaceuticals Corp Company Overview 50

5.15.1 DMK Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 50

5.16 Drexel University Company Overview 51

5.16.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview 51

5.17 Eli Lilly and Co Company Overview 52

5.17.1 Eli Lilly and Co Pipeline Products & Ongoing Clinical Trials Overview 52

5.18 Engage Therapeutics Inc Company Overview 53

5.18.1 Engage Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.19 Findair Sp zoo Company Overview 54

5.19.1 Findair Sp zoo Pipeline Products & Ongoing Clinical Trials Overview 54

5.20 FocusStart LLC Company Overview 57

5.20.1 FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 57

5.21 Glenmark Pharmaceuticals Ltd Company Overview 58

5.21.1 Glenmark Pharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 58

5.22 GSK plc Company Overview 59

5.22.1 GSK plc Pipeline Products & Ongoing Clinical Trials Overview 59

5.23 Hovione Technology Ltd Company Overview 60

5.23.1 Hovione Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

5.24 Iconovo AB Company Overview 61

5.24.1 Iconovo AB Pipeline Products & Ongoing Clinical Trials Overview 61

5.25 Lupin Pharmaceuticals Inc Company Overview 69

5.25.1 Lupin Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 69

5.26 MannKind Corp Company Overview 71

5.26.1 MannKind Corp Pipeline Products & Ongoing Clinical Trials Overview 71

5.27 Medihale Ltd (Inactive) Company Overview 76

5.27.1 Medihale Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 76

5.28 Monash University Company Overview 77

5.28.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 77

5.29 Nektar Therapeutics Company Overview 78

5.29.1 Nektar Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 78

5.30 North Carolina State University Company Overview 79

5.30.1 North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 79

5.31 Novartis AG Company Overview 80

5.31.1 Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 80

5.32 Ology Bioservices Inc Company Overview 86

5.32.1 Ology Bioservices Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.33 OPKO Health Inc Company Overview 88

5.33.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 88

5.34 OtiTopic Inc Company Overview 89

5.34.1 OtiTopic Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.35 Pai Life Sciences Inc Company Overview 92

5.35.1 Pai Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.36 Phargentis SA Company Overview 93

5.36.1 Phargentis SA Pipeline Products & Ongoing Clinical Trials Overview 93

5.37 Pharmaxis Ltd Company Overview 95

5.37.1 Pharmaxis Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

5.38 Pneuma Respiratory Inc Company Overview 96

5.38.1 Pneuma Respiratory Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.39 Pure Scientific Technologies Inc Company Overview 97

5.39.1 Pure Scientific Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 97

5.40 PureIMS BV Company Overview 98

5.40.1 PureIMS BV Pipeline Products & Ongoing Clinical Trials Overview 98

5.41 Quench Medical Inc Company Overview 103

5.41.1 Quench Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 103

5.42 Resolve Digital Health Inc Company Overview 104

5.42.1 Resolve Digital Health Inc Pipeline Products & Ongoing Clinical Trials Overview 104

5.43 Respira Therapeutics Inc Company Overview 106

5.43.1 Respira Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 106

5.44 Respirent Pharmaceuticals Co Ltd Company Overview 107

5.44.1 Respirent Pharmaceuticals Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

5.45 Rhinomed Ltd Company Overview 110

5.45.1 Rhinomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

5.46 Sandoz International GmbH Company Overview 113

5.46.1 Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 113

5.47 Seng Vital International GmbH Company Overview 115

5.47.1 Seng Vital International GmbH Pipeline Products & Ongoing Clinical Trials Overview 115

5.48 Sheffield Hallam University Company Overview 116

5.48.1 Sheffield Hallam University Pipeline Products & Ongoing Clinical Trials Overview 116

5.49 Shin Nippon Biomedical Laboratories Ltd Company Overview 117

5.49.1 Shin Nippon Biomedical Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

5.50 Sinsin Pharmaceutical Co Ltd Company Overview 118

5.50.1 Sinsin Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 118

5.51 Softhale NV Company Overview 120

5.51.1 Softhale NV Pipeline Products & Ongoing Clinical Trials Overview 120

5.52 Spyryx Biosciences Inc (Inactive) Company Overview 121

5.52.1 Spyryx Biosciences Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 121

5.53 Teva Pharmaceutical Industries Ltd Company Overview 122

5.53.1 Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 122

5.54 Transpire Bio Inc Company Overview 129

5.54.1 Transpire Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 129

5.55 University of Kansas Company Overview 134

5.55.1 University of Kansas Pipeline Products & Ongoing Clinical Trials Overview 134

5.56 University of Sydney Company Overview 135

5.56.1 University of Sydney Pipeline Products & Ongoing Clinical Trials Overview 135

5.57 University of Texas Medical Branch at Galveston Company Overview 136

5.57.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 136

5.58 Uscom Ltd Company Overview 137

5.58.1 Uscom Ltd Pipeline Products & Ongoing Clinical Trials Overview 137

5.59 Vectura Group Plc Company Overview 138

5.59.1 Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 138

5.60 Veoli Ltd Company Overview 141

5.60.1 Veoli Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

5.61 Verona Pharma Plc Company Overview 142

5.61.1 Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 142

5.62 Virginia Commonwealth University Company Overview 143

5.62.1 Virginia Commonwealth University Pipeline Products & Ongoing Clinical Trials Overview 143

6 Inhalers- Recent Developments 145

6.1 Nov 09, 2023: 3M Announces Leadership Changes 145

6.2 Nov 07, 2023: Teva appoints new CEO for Teva api, its Active Pharmaceutical Ingredients Business 145

6.3 Nov 02, 2023: Qualcomm Reports Q4 and Fiscal 2023 Results 146

6.4 Oct 31, 2023: United Therapeutics Announces First Patient Enrolled in Phase 3 TETON PPF Study of Nebulized Tyvaso in Patients with Progressive Pulmonary Fibrosis 146

6.5 Oct 30, 2023: Chiesi Announces New Senior Level Changes to Leadership Team 147

6.6 Oct 27, 2023: Cipla Announces Unaudited Consolidated Financial Results for Quarter Ended September 30th, 2023 147

6.7 Oct 24, 2023: 3M Reports Third Quarter 2023 Results; Company Increases Full Year Adjusted Earnings and Cash Flow Expectations 148

6.8 Oct 19, 2023: DMK Pharmaceuticals Restructures Executive Team to Support Next Phase of Growth 149

6.9 Oct 16, 2023: Orion publishes Interim Report for January–September 2023 on Thursday 26 October 2023 149

6.10 Oct 15, 2023: Qualcomm To Layoff 1,258 Employees In Two Locations, Experts State That U.S. Efforts To Suppress China Backfired And Is Affecting Firms 150

6.11 Oct 13, 2023: Qualcomm to Lay Off 1,258 Employees in California 150

6.12 Oct 12, 2023: Qualcomm to Cut Roughly 1258 Jobs in California 150

6.13 Sep 28, 2023: Teva Announces Changes to Executive Management Team 150

6.14 Sep 27, 2023: Milestone Pharmaceuticals Announces Etripamil AFib-RVR Study is Selected for Featured Science Presentation at the AHA Scientific Sessions 2023 151

6.15 Sep 05, 2023: MannKind Announces Participation at Upcoming Conferences 151

6.16 Aug 28, 2023: Novartis to Let Go 100 Employees in Latest Round of Layoffs 152

6.17 Aug 23, 2023: 3M Appoints Carrie Cox as Chairman of the Board of Directors of the Independent Health Care Company 152

6.18 Aug 22, 2023: Bryan Hanson Named CEO of 3M’s Health Care Business Group 152

6.19 Aug 18, 2023: Qualcomm to Reportedly Cut 200 Jobs in Taiwan 153

6.20 Aug 17, 2023: Iconovo Receives Additional Development Contract From Kiox Pharma For New Inhalable Treatment Against Rare Disease 153

6.21 Aug 17, 2023: Ziccum to present at Investor Conference BioFuture 2023 in New York 154

6.22 Aug 03, 2023: Qualcomm Announces Third Quarter Fiscal 2023 Results 154

6.23 Aug 01, 2023: MannKind Announces Participation in the 2023 Wedbush PacGrow Healthcare Conference 155

6.24 Jul 31, 2023: Viatris Announces Launch of Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the First FDA-Approved Generic Version of Symbicort for People with Asthma and Chronic Obstructive Pulmonary Disease, in Partnership with Kindeva 155

6.25 Jul 31, 2023: MannKind to Hold 2023 Second Quarter Financial Results Conference Call on August 7, 2023 156

6.26 Jul 21, 2023: Teva UK Launches New Goresp Digihaler System in UK 156

6.27 Jul 07, 2023: Alessandro Chiesi appointed Chair of the Chiesi Group Maria Paola Chiesi becomes the Vice Chair 156

6.28 Jul 05, 2023: Teva to Host Conference Call to Discuss Second Quarter 2023 Financial Results at 8 a.m. ET on August 2, 2 157

6.29 Jul 04, 2023: Orion Publishes Half-year Financial Report for January – June 2023 157

6.30 Jun 19, 2023: Iconovo Initiates Feasibility Study With Affilogic for Development of Inhalable Nanofitin-Based Biotherapies 158

6.31 Jun 06, 2023: Phil and Teva Pharmaceuticals Launch New Program to Improve Access to the Digihaler Family of Inhalers to Support Asthma Management 158

6.32 Jun 02, 2023: Ziccum appoints senior biopharma executive as new CFO 159

6.33 May 24, 2023: Ziccum: Bulletin from the Annual General Meeting 160

6.34 May 24, 2023: Dr. Burkhard Blank joins MannKind as executive vice president of research & development and chief medical officer 161

6.35 May 22, 2023: Milestone Pharmaceuticals announces analysis of etripamil nasal spray in patients experiencing atrial fibrillation with rapid ventricular rate 161

6.36 May 15, 2023: Savara reports first quarter financial results and provides business update 163

6.37 May 15, 2023: Adamis Pharmaceuticals reports Q1 2023 financial results and provides corporate update 163

6.38 May 12, 2023: Cipla announces audited consolidated financial results for year ended 31st march 2023 165

6.39 May 11, 2023: Iconovo’s partner Monash University has initiated a phase I clinical trial on inhaled oxytocin in ICOone 165

6.40 May 09, 2023: 3M annual meeting highlights business portfolio, innovation, and actions to drive future performance 165

6.41 May 09, 2023: Mannkind reports 2023 first quarter financial results 166

6.42 May 08, 2023: Acorda Therapeutics and Chance Pharmaceuticals announce agreement to commercialize INBRIJA in China 167

6.43 May 08, 2023: Adamis Pharmaceuticals schedules Q1 2023 financial results conference call and corporate update 168

6.44 May 03, 2023: Hovione and H&T Presspart extend partnership to advance high efficiency device technology for Dry Powder Inhalation formulation delivery 168

6.45 May 02, 2023: MannKind Corp. to hold 2023 first quarter financial results conference call on May 9, 2023 169

6.46 Apr 28, 2023: Cipla announces earning conference call 169

6.47 Apr 28, 2023: Iconovo Publishes Annual Report for 2022 169

6.48 Apr 28, 2023: Iconovo Announces Interim Report January – March 2023 169

6.49 Apr 26, 2023: Ziccum announces releases of interim report Q1 2023 170

6.50 Apr 25, 2023: OPKO Health to report Q1 2023 financial results on May 3, 2023 172

6.51 Apr 25, 2023: 3M announces more layoffs 172

6.52 Apr 25, 2023: Introducing the Copley Impactor Genie IG 200i, a two-in-one solution for quicker, more efficient inhaled product testing 172

6.53 Apr 20, 2023: Iconovo announces notice to the annual general meeting 173

6.54 Apr 13, 2023: Orion publishes Interim Report for January–March 2023 on Thursday 27 April 2023 175

6.55 Apr 04, 2023: PureIMS secures funding to develop inhalation product 176

6.56 Mar 31, 2023: Arcede Pharma AB: Funding received from Swelife for the development of a new treatment for COPD and severe asthma 176

6.57 Mar 31, 2023: Bellerophon Provides Clinical Program Update and Reports Full-Year 2022 Financial Results 177

6.58 Mar 30, 2023: Savara Reports Fourth Quarter Year-End 2022 Financial Results and Provides Business Update 179

6.59 Mar 27, 2023: Lauren Sabella Joins Mannkind as Executive Vice President, Chief Operating Officer 180

6.60 Mar 14, 2023: Adamis Pharmaceuticals Schedules Fourth Quarter and Full Year 2022 Financial Results Conference Call and Corporate Update 181

6.61 Mar 10, 2023: GSK publishes Annual Report 2022 181

6.62 Mar 06, 2023: Savara to Present at the Oppenheimer 33rd Annual Healthcare Conference 182

6.63 Feb 28, 2023: Orion Group Announces Financial Statement documents 2022, Corporate Governance Statement and Remuneration Report published 182

6.64 Feb 23, 2023: MannKind Corp. Reports 2022 Fourth Quarter and Full Year Financial Results 182

6.65 Feb 22, 2023: Novo Nordisk Notice for the Annual General Meeting 184

6.66 Feb 17, 2023: ZICCUM releases Annual Report 2022 185

6.67 Feb 16, 2023: OPKO Health to Report Fourth Quarter 2022 Financial Results on February 23, 2023 185

6.68 Feb 16, 2023: MannKind Corp. to Hold 2022 Fourth Quarter and Full Year Financial Results Conference Call on February 23, 2023 185

6.69 Feb 15, 2023: The Access to Advanced Health Institute announces $3M award to develop an intranasal pan-viral countermeasure against respiratory viruses 185

6.70 Feb 14, 2023: Savara Announces New Leadership Appointments 186

6.71 Feb 13, 2023: Adherium exhibiting at AAAAI 2023 Annual Meeting 187

6.72 Feb 09, 2023: Orion Group Announces Financial Statement Release 2022 187

6.73 Feb 08, 2023: Iconovo Announces Financial Statement 1 January to 31 December 2022 192

6.74 Feb 01, 2023: Novartis Announces Annual Report 2022 194

6.75 Jan 30, 2023: Chiesi appoints Giuseppe Accogli as new Group CEO 195

6.76 Jan 29, 2023: Two global innovative compound preparation products of the group for the treatment of asthma were officially included in the national medical insurance catalog 196

6.77 Jan 26, 2023: Iconovo receives approval of new European patent for its single-use inhaler ICOone 197

6.78 Jan 26, 2023: Orion publishes Financial Statement Release for 2022 on Thursday 9 February 2023 198

6.79 Jan 25, 2023: Pulmatrix to host key opinion leader webinar “PUR3100 for the treatment of acute migraine: Unlocking the potential of DHE treatment” 198

6.80 Jan 25, 2023: Cipla announces Q3FY23 results 199

6.81 Jan 25, 2023: Brand new state-of-the-art Nemera manufacturing facility inaugurated in Poland 199

6.82 Jan 24, 2023: 3M Reports Fourth-Quarter and Full-Year 2022 Results 200

6.83 Jan 24, 2023: 3M Lays off 2500 employees 202

6.84 Jan 18, 2023: Adherium awarded UK National Health Service’s SBRI Healthcare Monitoring Project 202

6.85 Jan 12, 2023: Teva to Host Conference Call to Discuss Fourth Quarter and Full Year 2022 Financial Results and 2023 Financial Guidance at 8 a.m. ET on February 8, 2023 203

6.86 Jan 11, 2023: Cipla Announces Earning Conference call schedule on 25th January 2023 11th Jan 2023 203

6.87 Jan 09, 2023: Pneuma Respiratory shares improvements to digital soft mist inhaler at J.P Morgan Healthcare Conference 204

6.88 Dec 26, 2022: Sunovion Plans To Lay Off 360 Employees in 2023 204

6.89 Dec 15, 2022: Iconovo appoints Henrik Damkjær Simonsen as Chief Financial Officer 204

6.90 Dec 13, 2022: Rapid Therapeutic Science Laboratories updates Patents 205

6.91 Dec 07, 2022: Iconovo’s ICOone inhaler platform receives new patent approval in the US 205

7 Appendix 206

7.1 Methodology 206

7.2 About GlobalData 209

7.3 Contact Us 209

7.4 Disclaimer 209

Table

Inhalers – Pipeline Products by Stage of Development 16

Inhalers – Pipeline Products by Segment 17

Inhalers – Pipeline Products by Territory 18

Inhalers – Pipeline Products by Regulatory Path 20

Inhalers – Pipeline Products by Estimated Approval Date 21

Inhalers – Ongoing Clinical Trials 22

Inhalers Companies – Pipeline Products by Stage of Development 23

Inhalers – Pipeline Products by Stage of Development 26

1nhaler Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

Single-Use Dry Powder Inhaler – Product Status 29

Single-Use Dry Powder Inhaler – Product Description 29

Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 30

INBRIJA – Product Status 30

INBRIJA – Product Description 30

PLUMIAZ Nasal Spray Device – Product Status 31

PLUMIAZ Nasal Spray Device – Product Description 31

Acorda Therapeutics Inc – Ongoing Clinical Trials Overview 32

INBRIJA – Usability of Levodopa Cyclops Compared to INBRIJA During an Off Episode in Parkinson’s Disease Patients 33

Advent Pharmaceuticals Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 34

g60 Dry Powder Inhaler – Product Status 34

g60 Dry Powder Inhaler – Product Description 34

Aerami Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 35

AFINA Smart Inhaler – Product Status 35

AFINA Smart Inhaler – Product Description 35

Aespira Ltd. Pipeline Products & Ongoing Clinical Trials Overview 36

resQhaler – Product Status 36

resQhaler – Product Description 36

AKELA Pharma Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 37

Fentanyl TAIFUN Inhaler – Product Status 37

Fentanyl TAIFUN Inhaler – Product Description 37

AsMedic Ltd. Pipeline Products & Ongoing Clinical Trials Overview 38

Reusable Inhaler – Product Status 38

Reusable Inhaler – Product Description 38

Bayer AG Pipeline Products & Ongoing Clinical Trials Overview 39

Ciprofloxacin Dry Powder Inhaler – Product Status 39

Ciprofloxacin Dry Powder Inhaler – Product Description 40

Claricare – Product Status 40

Claricare – Product Description 40

Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Mark2 Device – Product Status 41

Mark2 Device – Product Description 41

Cambridge Healthcare Innovations Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

aeolus Dry-Powder Inhaler (DPI) – Product Status 42

aeolus Dry-Powder Inhaler (DPI) – Product Description 42

Cipla Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

Complex Inhaler – Product Status 43

Complex Inhaler – Product Description 43

Smart Inhaler – Product Status 44

Smart Inhaler – Product Description 44

Covinhaler LLP Pipeline Products & Ongoing Clinical Trials Overview 45

Pocket Inhaler – COVID-19 – Product Status 45

Pocket Inhaler – COVID-19 – Product Description 45

Creare LLC Pipeline Products & Ongoing Clinical Trials Overview 46

Intranasal Dry Powder Inhaler – Product Status 46

Intranasal Dry Powder Inhaler – Product Description 46

De Motu Cordis Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

DMC Inhaler – Product Status 47

DMC Inhaler – Product Description 47

De Motu Cordis Pty Ltd – Ongoing Clinical Trials Overview 48

DMC Inhaler – A Phase 1, 2-Part Study in Healthy Male and Female Participants; Part 1 – A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose-Escalation Study of Inhaled DMC-IH1; Part 2 – An Open-Label, 3-Arm Study Assessing the Carryover Effects of Inhaled (DMC-IH1) and Intramuscular (EpiPen) Epinephrine 49

DMK Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 50

APC-4000 Fluticasone Dry Powder Inhaler – Product Status 50

APC-4000 Fluticasone Dry Powder Inhaler – Product Description 50

Drexel University Pipeline Products & Ongoing Clinical Trials Overview 51

BREATHE Inhaler – Product Status 51

BREATHE Inhaler – Product Description 51

Eli Lilly and Co Pipeline Products & Ongoing Clinical Trials Overview 52

Nasal Glucagon Delivery System – Product Status 52

Nasal Glucagon Delivery System – Product Description 52

Engage Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Staccato Alprazolam – Product Status 53

Staccato Alprazolam – Product Description 53

Findair Sp zoo Pipeline Products & Ongoing Clinical Trials Overview 54

FindAir ONE Smart Inhaler – Product Status 54

FindAir ONE Smart Inhaler – Product Description 54

Findair Sp zoo – Ongoing Clinical Trials Overview 55

FindAir ONE Smart Inhaler – Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease 56

FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 57

Smart Inhaler – Product Status 57

Smart Inhaler – Product Description 57

Glenmark Pharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 58

Tiogiva – Product Status 58

Tiogiva – Product Description 58

GSK plc Pipeline Products & Ongoing Clinical Trials Overview 59

Gemini Multi-Dose Combination Inhaler – Product Status 59

Gemini Multi-Dose Combination Inhaler – Product Description 59

Hovione Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

Papillon DPI – Product Status 60

Papillon DPI – Product Description 60

Iconovo AB Pipeline Products & Ongoing Clinical Trials Overview 61

ICOcap – Product Status 61

ICOcap – Product Description 61

ICOone – Product Status 62

ICOone – Product Description 62

ICOone – Oxytocin – Product Status 62

ICOone – Oxytocin – Product Description 63

ICOpre – Product Status 63

ICOpre – Product Description 63

ICOres – Product Status 64

ICOres – Product Description 64

Multi-Dose Delivery Device – Product Status 64

Multi-Dose Delivery Device – Product Description 65

Iconovo AB – Ongoing Clinical Trials Overview 66

ICOone – A Feasibility Study with Affilogic for the Development of Inhalable Nanofitin-based Biotherapies 67

ICOone – Oxytocin – A Randomized, Single-Center, Partially Single-Blind Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Single and Repeated Doses of Oxytocin Administered via Inhalation or Intravenous or Intramuscular Administration in Healthy Female Participants 68

Lupin Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 69

Dry Powder Inhaler 1 – Product Status 69

Dry Powder Inhaler 1 – Product Description 69

Dry Powder Inhaler 2 – Product Status 70

Dry Powder Inhaler 2 – Product Description 70

Tiotropium DPI – Product Status 70

Tiotropium DPI – Product Description 70

MannKind Corp Pipeline Products & Ongoing Clinical Trials Overview 71

Afrezza – Pediatric Use – Product Status 71

Afrezza – Pediatric Use – Product Description 72

Afrezza Inhaler – Product Status 72

Afrezza Inhaler – Product Description 72

Treprostinil Technosphere – Product Status 73

Treprostinil Technosphere – Product Description 73

MannKind Corp – Ongoing Clinical Trials Overview 74

Afrezza Inhaler – INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined with Insulin Degludec Versus Usual Care in Adults with Type 1 Diabetes 75

Medihale Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 76

Toucan Multi-Dose Inhaler – Product Status 76

Toucan Multi-Dose Inhaler – Product Description 76

Monash University Pipeline Products & Ongoing Clinical Trials Overview 77

Aerosol Delivery System – Product Status 77

Aerosol Delivery System – Product Description 77

Nektar Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 78

NKTR-061 – Product Status 78

NKTR-061 – Product Description 78

North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 79

Smart Inhaler System – Product Status 79

Smart Inhaler System – Product Description 79

Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 80

Atectura Breezhaler – Product Status 80

Atectura Breezhaler – Product Description 81

Enerzair Breezhaler – Product Status 81

Enerzair Breezhaler – Product Description 81

Next Generation Breezhaler Inhaler – Product Status 82

Next Generation Breezhaler Inhaler – Product Description 82

Novartis AG – Ongoing Clinical Trials Overview 83

Enerzair Breezhaler – A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Enerzair (QVM149 150/50/80 µg o.d. and QVM149 150/50/160 µg o.d. Via Breezhaler) 84

Enerzair Breezhaler – A Double-dummy, Double-blind, Randomized, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. 84

Enerzair Breezhaler – Comparison of Enerziar and Trelegy, Single Inhaler Triple Therapy (SITT), in Asthma 84

Atectura Breezhaler – A 24-week Prospective, Open-label, Multicenter, Single-arm Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Atectura (QMF149 150/80 µg o.d., QMF149 150/160 µg o.d. and QMF149 150/320 µg o.d. Via Breezhaler) 85

Atectura Breezhaler – A Double-dummy, Double-blind, Randomized, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. 85

Ology Bioservices Inc Pipeline Products & Ongoing Clinical Trials Overview 86

GelVac Intranasal Powder Vaccine Delivery System – Product Status 86

GelVac Intranasal Powder Vaccine Delivery System – Product Description 86

NanoGENT – Product Status 87

NanoGENT – Product Description 87

OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 88

Inspiromatic – Product Status 88

Inspiromatic – Product Description 88

OtiTopic Inc Pipeline Products & Ongoing Clinical Trials Overview 89

ASPRIHALE – Product Status 89

ASPRIHALE – Product Description 89

OtiTopic Inc – Ongoing Clinical Trials Overview 90

ASPRIHALE – A Phase I, Single-dose, Open-label, Pilot Study to Compare the Pharmacodynamics and Pharmacokinetics of Acetylsalicylic Acid Inhalation Powder with Non-enteric-coated Chewable Aspirin in Healthy Adults 91

Pai Life Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 92

Inhaled Delivery System – Tuberculosis – Product Status 92

Inhaled Delivery System – Tuberculosis – Product Description 92

Phargentis SA Pipeline Products & Ongoing Clinical Trials Overview 93

Glide DPI – Product Status 93

Glide DPI – Product Description 93

Indacaterol/Glycopyrronium DPI – Product Status 94

Indacaterol/Glycopyrronium DPI – Product Description 94

Pharmaxis Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

Orbital Dry Powder Inhaler – Product Status 95

Orbital Dry Powder Inhaler – Product Description 95

Pneuma Respiratory Inc Pipeline Products & Ongoing Clinical Trials Overview 96

PNEUMAHALER – Product Status 96

PNEUMAHALER – Product Description 96

Pure Scientific Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 97

PST Closed Loop Heliox Inhaler – Product Status 97

PST Closed Loop Heliox Inhaler – Product Description 97

PureIMS BV Pipeline Products & Ongoing Clinical Trials Overview 98

Amikacin Cyclops – Product Status 98

Amikacin Cyclops – Product Description 98

Epinephrine Cyclops – Product Status 99

Epinephrine Cyclops – Product Description 99

Levodopa Cyclops – Product Status 99

Levodopa Cyclops – Product Description 100

Tobramycin Cyclops – Product Status 100

Tobramycin Cyclops – Product Description 100

PureIMS BV – Ongoing Clinical Trials Overview 101

Levodopa Cyclops – Usability of Levodopa Cyclops Compared to INBRIJA During an Off Episode in Parkinson’s Disease Patients 102

Quench Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 103

Dry Powder Inhaler – Product Status 103

Dry Powder Inhaler – Product Description 103

Resolve Digital Health Inc Pipeline Products & Ongoing Clinical Trials Overview 104

Resolve Go MD – Product Status 104

Resolve Go MD – Product Description 104

Resolve MD – Product Status 104

Resolve MD – Product Description 105

Resolve Mini MD – Product Status 105

Resolve Mini MD – Product Description 105

Respira Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 106

RT234 AOS DPI – Product Status 106

RT234 AOS DPI – Product Description 106

Respirent Pharmaceuticals Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

Flovent Diskus – Generic Version – Product Status 107

Flovent Diskus – Generic Version – Product Description 107

Respirent Pharmaceuticals Co Ltd – Ongoing Clinical Trials Overview 108

Flovent Diskus – Generic Version – A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals Vs. FLOVENT DISKUS 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers 109

Rhinomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

Pronto Allergy Relief – Product Status 110

Pronto Allergy Relief – Product Description 110

Pronto Focus – Product Status 111

Pronto Focus – Product Description 111

Pronto Nausea Relief – Product Status 111

Pronto Nausea Relief – Product Description 112

Pronto Sleep Performance – Product Status 112

Pronto Sleep Performance – Product Description 112

Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 113

Solis Multi-Dose Dry Powder Inhaler – Product Status 113

Solis Multi-Dose Dry Powder Inhaler – Product Description 113

Unit-Dose Dry Powder Inhaler – Product Status 114

Unit-Dose Dry Powder Inhaler – Product Description 114

Seng Vital International GmbH Pipeline Products & Ongoing Clinical Trials Overview 115

Cannamed – Product Status 115

Cannamed – Product Description 115

Sheffield Hallam University Pipeline Products & Ongoing Clinical Trials Overview 116

Dry Powder Inhaler – Product Status 116

Dry Powder Inhaler – Product Description 116

Shin Nippon Biomedical Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

STS101 Dry Powder Delivery Device – Product Status 117

STS101 Dry Powder Delivery Device – Product Description 117

Sinsin Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 118

BVA110 – Product Status 118

BVA110 – Product Description 118

DFA001 – Product Status 119

DFA001 – Product Description 119

Softhale NV Pipeline Products & Ongoing Clinical Trials Overview 120

Softhaler – Product Status 120

Softhaler – Product Description 120

Spyryx Biosciences Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 121

SPX-250 Dry Powder Inhaler – Product Status 121

SPX-250 Dry Powder Inhaler – Product Description 121

Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 122

AirDuo Digihaler – Product Status 122

AirDuo Digihaler – Product Description 123

ArmonAir Digihaler – Product Status 123

ArmonAir Digihaler – Product Description 123

Inhaler Device – Product Status 124

Inhaler Device – Product Description 124

ProAir Digihaler – Product Status 124

ProAir Digihaler – Product Description 125

Tidal Inhaler – Product Status 125

Tidal Inhaler – Product Description 125

Teva Pharmaceutical Industries Ltd – Ongoing Clinical Trials Overview 126

ProAir Digihaler – Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma 127

AirDuo Digihaler – Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma 128

Transpire Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 129

CNS Inhaler 1 – Product Status 129

CNS Inhaler 1 – Product Description 129

CNS Inhaler 2 – Product Status 130

CNS Inhaler 2 – Product Description 130

Dry Powder Inhaler (DPI) – Asthma COPD – Product Status 130

Dry Powder Inhaler (DPI) – Asthma COPD – Product Description 131

Dry Powder Inhaler (DPI) – COPD – Product Status 131

Dry Powder Inhaler (DPI) – COPD – Product Description 131

Oncology Inhaler – Product Status 132

Oncology Inhaler – Product Description 132

Soft Mist Inhaler (SMI) – COPD – Product Status 132

Soft Mist Inhaler (SMI) – COPD – Product Description 133

University of Kansas Pipeline Products & Ongoing Clinical Trials Overview 134

Dry Powder Inhaler – Product Status 134

Dry Powder Inhaler – Product Description 134

University of Sydney Pipeline Products & Ongoing Clinical Trials Overview 135

Dry Powder Inhaler – Product Status 135

Dry Powder Inhaler – Product Description 135

University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 136

Dry Powder Drug Delivery System – Product Status 136

Dry Powder Drug Delivery System – Product Description 136

Uscom Ltd Pipeline Products & Ongoing Clinical Trials Overview 137

Spirosonic SmartSpacer – Product Status 137

Spirosonic SmartSpacer – Product Description 137

Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 138

Digitally – Connected LOMI Device – Product Status 138

Digitally – Connected LOMI Device – Product Description 138

MRX006 – Multidose Combined DPI Inhaler – Product Status 139

MRX006 – Multidose Combined DPI Inhaler – Product Description 139

SKP-2075 – Product Status 139

SKP-2075 – Product Description 140

Veoli Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

Cannabis Inhaler Device – Product Status 141

Cannabis Inhaler Device – Product Description 141

Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 142

RPL554 – Dry Powder Inhaler – Product Status 142

RPL554 – Dry Powder Inhaler – Product Description 142

Virginia Commonwealth University Pipeline Products & Ongoing Clinical Trials Overview 143

Drug Delivery Device – Cystic Fibrosis – Product Status 143

Drug Delivery Device – Cystic Fibrosis – Product Description 143

Dry Powder Inhaler – Product Status 144

Dry Powder Inhaler – Product Description 144

Glossary 208

Figures

Inhalers – Pipeline Products by Stage of Development 15_x000D_

Inhalers – Pipeline Products by Segment 16_x000D_

Inhalers – Pipeline Products by Territory 17_x000D_

Inhalers – Pipeline Products by Regulatory Path 19_x000D_

Inhalers – Pipeline Products by Estimated Approval Date 20_x000D_

Inhalers – Ongoing Clinical Trials 21_x000D_

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