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

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Inhalable Drug Delivery Pipeline Market Report Overview

An inhalable drug delivery device is meant to administer medications that are to be inhaled deeply into the lungs. Drugs are delivered either by the nasal or oral respiratory route.

The Inhalable Drug Delivery pipeline market research report provides comprehensive information about the inhalable drug delivery pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials that are in progress.

Key Segments ·        Nebulizer Systems

·        Aqueous Systems

Key Territories ·        The US

·        Europe

·        China

·        Canada

·        Australia

·        Singapore

·        South Korea

·        Taiwan

·        Thailand

·        Malaysia

Key Regulatory Paths ·        510(k)

·        CE

·        NMPA

·        MDL

·        TGA

·        HAS

·        ICAC

·        MDA

·        BOPA

·        MDITAC

Leading Companies ·        Ablynx NV

·        Acorda Therapeutics Inc

·        Actervis GmbH

·        Aeon Research & Technology

·        Aerami Therapeutics Inc

·        Aerophase Inc

·        AFT Pharmaceuticals Ltd

·        Alexza Pharmaceuticals Inc

·        Ayuda Medical LLC

·        Baby’s Breath Ltd

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Inhalable Drug Delivery Pipeline Market by Segments

The key segments in the inhalable drug delivery pipeline market are nebulizer systems and aqueous systems. As of September 2023, the nebulizer system has a higher number of pipeline products.

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

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

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Inhalable Drug Delivery Pipeline Market Segmentation by Territories

Some of the key territories in the inhalable drug delivery market are the US, Europe, China, Canada, Australia, Singapore, South Korea, Taiwan, Thailand, and Malaysia. As of September 2023, the US has the highest number of pipeline products.

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

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

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Inhalable Drug Delivery Pipeline Market Segmentation by Regulatory Paths

Some of the key regulatory paths in the inhalable drug delivery pipeline market are 510(k), CE, NMPA, MDL, TGA, HSA, ICAC, MDA, BOPA, and MDITAC. As of September 2023, 510(k) is the most followed pathway for pipeline products in the market.

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

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

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Inhalable Drug Delivery Pipeline Market – Competitive Landscape

Some of the key companies in the inhalable drug delivery pipeline market are Ablynx NV, Acorda Therapeutics Inc, Actervis GmbH, Aeon Research & Technology, Aerami Therapeutics Inc, Aerophase Inc, AFT Pharmaceuticals Ltd, Alexza Pharmaceuticals Inc, Ayuda Medical LLC, and Baby’s Breath Ltd.

Ablynx NV: It is a biopharmaceutical company that focuses on developing Nanobodies, proprietary therapeutic proteins based on single-domain antibody fragments. The company’s proprietary Nanobody platform allows the rapid generation and large-scale production of novel biological therapeutics that have the potential to be used in a wide range of human diseases. The company has research collaborations and significant partnerships with key pharmaceutical companies including Merck, Novartis, and Boehringer Ingelheim. Ablynx is headquartered in Ghent, Belgium.

Acorda Therapeutics Inc: It is a biopharmaceutical company that discovers, develops, and markets therapies for treating patients with neurological disorders. The company’s portfolio encompasses marketed products for the treatment of multiple sclerosis (MS) and for the intermittent treatment of people with Parkinson’s taking levodopa or carbidopa who experience off episodes. Acorda is headquartered in Ardsley, New York, the US.

Inhalable Drug Delivery Pipeline Market Analysis by Companies, 2023

Inhalable Drug Delivery Pipeline Market Analysis by Companies, 2023

Buy Full Report for More Company Insights into the Inhalable Drug Delivery Pipeline Market

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Segments Covered in the Report

Inhalable Drug Delivery Pipeline Market Segments Outlook

  • Nebulizer Systems
  • Aqueous Systems

Inhalable Drug Delivery Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • Canada
  • Australia
  • Singapore
  • South Korea
  • Taiwan
  • Thailand
  • Malaysia

Inhalable Drug Delivery Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE
  • NMPA
  • MDL
  • TGA
  • HAS
  • ICAC
  • MDA
  • BOPA
  • MDITAC

Scope

This report provides:

  • Extensive coverage of the inhalable drug delivery under development.
  • Details of major pipeline products which include product description, licensing and collaboration details and other developmental activities.
  • Reviews of major players involved in the development of inhalable drug delivery and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Provides key clinical trial data of ongoing clinical 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 portfolio and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of inhalable 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.

Ablynx NV
Acorda Therapeutics Inc
Actervis GmbH
Aeon Research & Technology
Aerami Therapeutics Inc
Aerophase Inc
AFT Pharmaceuticals Ltd
Alexza Pharmaceuticals Inc
Ayuda Medical LLC
Baby's Breath Ltd
Baxter International Inc
Bellerophon Therapeutics Inc
Breath Therapeutics Holding BV
Bridgesource Medical Corp
California Northstate University College of Medicine
Canigma A.L LTD
Cognigenics Inc
Creare LLC
Cybin Inc
Department of Biomedical Engineering Columbia University
DesignWise Medical Inc (Inactive)
Edixomed Ltd
HCmed Innovations Co Ltd
HOLLO Medical Inc
iDTx Systems, Inc.
Impel Pharmaceuticals Inc
Inhalation Sciences Sweden AB
Invero Pharma LLC
Jupiter Research LLC
KAER Biotherapeutics Corp
Kanabo Research Ltd
Lupin Pharmaceuticals Inc
Mallinckrodt Plc
Marquette University
Medspray BV
Monash University
Nemera La Verpilliere
Next Safety, Inc.
Nob Hill Therapeutics Inc
Nobilis Therapeutics Inc
Omron Healthcare Co Ltd
Omron Healthcare Inc
OncoSec Medical Inc
PARI GmbH
Parion Sciences Inc
Pharmosa Biopharm Inc
Respira Technologies Inc
Rhinomed Ltd
Risproly
RMIT University
Rutgers Cancer Institute of New Jersey
Sandoz International GmbH
Shenzhen Smoore Technology Ltd
Sino Biopharmaceutical Ltd
SolAeroMed Inc
Stevanato Group
Stirling Pharma Inc
Suzhou Wulian Medical Technology Co Ltd
Technology Commercialization Partners LLC
Teleflex Inc
Tetra Bio-Pharma Inc
Teva Pharmaceutical Industries Ltd
Texas Tech University Health Sciences Center
Third Pole Inc
Tiziana Life Sciences PLC
University Hospital Southampton NHS Foundation Trust
University of California San Diego
University of Texas Health Science Center at Houston
University of Texas Medical Branch at Galveston
Vectura Group Plc
Veoli Ltd
Vero Biotech LLC
Verona Pharma Plc
Via Therapeutics LLC
Vincent Medical Holdings Ltd
Virpax Pharmaceuticals Inc
VistaGen Therapeutics Inc
VitalMIST
Wellfully Ltd
Wellinks Inc
Windtree Therapeutics Inc

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 7

|1.2 List of Figures 14

2 Introduction 15

2.1 Inhalable Drug Delivery Overview 15

3 Products under Development 16

3.1 Inhalable Drug Delivery – Pipeline Products by Stage of Development 16

3.2 Inhalable Drug Delivery – Pipeline Products by Segment 17

3.3 Inhalable Drug Delivery – Pipeline Products by Territory 18

3.4 Inhalable Drug Delivery – Pipeline Products by Regulatory Path 20

3.5 Inhalable Drug Delivery – Pipeline Products by Estimated Approval Date 21

3.6 Inhalable Drug Delivery – Ongoing Clinical Trials 22

4 Inhalable Drug Delivery – Pipeline Products under Development by Companies 23

4.1 Inhalable Drug Delivery Companies – Pipeline Products by Stage of Development 23

4.2 Inhalable Drug Delivery – Pipeline Products by Stage of Development 27

5 Inhalable Drug Delivery Companies and Product Overview 30

5.1 Ablynx NV Company Overview 30

5.1.1 Ablynx NV Pipeline Products & Ongoing Clinical Trials Overview 30

5.2 Acorda Therapeutics Inc Company Overview 31

5.2.1 Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.3 Actervis GmbH Company Overview 32

5.3.1 Actervis GmbH Pipeline Products & Ongoing Clinical Trials Overview 32

5.4 Aeon Research & Technology Company Overview 33

5.4.1 Aeon Research & Technology Pipeline Products & Ongoing Clinical Trials Overview 33

5.5 Aerami Therapeutics Inc Company Overview 34

5.5.1 Aerami Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.6 Aerophase Inc Company Overview 35

5.6.1 Aerophase Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.7 AFT Pharmaceuticals Ltd Company Overview 36

5.7.1 AFT Pharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

5.8 Alexza Pharmaceuticals Inc Company Overview 39

5.8.1 Alexza Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.9 Ayuda Medical LLC Company Overview 40

5.9.1 Ayuda Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 40

5.10 Baby’s Breath Ltd Company Overview 41

5.10.1 Baby’s Breath Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

5.11 Baxter International Inc Company Overview 42

5.11.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 42

5.12 Bellerophon Therapeutics Inc Company Overview 43

5.12.1 Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.13 Breath Therapeutics Holding BV Company Overview 48

5.13.1 Breath Therapeutics Holding BV Pipeline Products & Ongoing Clinical Trials Overview 48

5.14 Bridgesource Medical Corp Company Overview 52

5.14.1 Bridgesource Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 52

5.15 California Northstate University College of Medicine Company Overview 53

5.15.1 California Northstate University College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 53

5.16 Canigma A.L LTD Company Overview 54

5.16.1 Canigma A.L LTD Pipeline Products & Ongoing Clinical Trials Overview 54

5.17 Cognigenics Inc Company Overview 55

5.17.1 Cognigenics Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.18 Creare LLC Company Overview 56

5.18.1 Creare LLC Pipeline Products & Ongoing Clinical Trials Overview 56

5.19 Cybin Inc Company Overview 57

5.19.1 Cybin Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.20 Department of Biomedical Engineering Columbia University Company Overview 58

5.20.1 Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 58

5.21 DesignWise Medical Inc (Inactive) Company Overview 59

5.21.1 DesignWise Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 59

5.22 Edixomed Ltd Company Overview 60

5.22.1 Edixomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

5.23 HCmed Innovations Co Ltd Company Overview 61

5.23.1 HCmed Innovations Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 61

5.24 HOLLO Medical Inc Company Overview 62

5.24.1 HOLLO Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.25 iDTx Systems, Inc. Company Overview 63

5.25.1 iDTx Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63

5.26 Impel Pharmaceuticals Inc Company Overview 64

5.26.1 Impel Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.27 Inhalation Sciences Sweden AB Company Overview 68

5.27.1 Inhalation Sciences Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 68

5.28 Invero Pharma LLC Company Overview 71

5.28.1 Invero Pharma LLC Pipeline Products & Ongoing Clinical Trials Overview 71

5.29 Jupiter Research LLC Company Overview 72

5.29.1 Jupiter Research LLC Pipeline Products & Ongoing Clinical Trials Overview 72

5.30 KAER Biotherapeutics Corp Company Overview 73

5.30.1 KAER Biotherapeutics Corp Pipeline Products & Ongoing Clinical Trials Overview 73

5.31 Kanabo Research Ltd Company Overview 74

5.31.1 Kanabo Research Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

5.32 Lupin Pharmaceuticals Inc Company Overview 78

5.32.1 Lupin Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 78

5.33 Mallinckrodt Plc Company Overview 79

5.33.1 Mallinckrodt Plc Pipeline Products & Ongoing Clinical Trials Overview 79

5.34 Marquette University Company Overview 80

5.34.1 Marquette University Pipeline Products & Ongoing Clinical Trials Overview 80

5.35 Medspray BV Company Overview 81

5.35.1 Medspray BV Pipeline Products & Ongoing Clinical Trials Overview 81

5.36 Monash University Company Overview 84

5.36.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 84

5.37 Nemera La Verpilliere Company Overview 86

5.37.1 Nemera La Verpilliere Pipeline Products & Ongoing Clinical Trials Overview 86

5.38 Next Safety, Inc. Company Overview 87

5.38.1 Next Safety, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87

5.39 Nob Hill Therapeutics Inc Company Overview 88

5.39.1 Nob Hill Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 88

5.40 Nobilis Therapeutics Inc Company Overview 89

5.40.1 Nobilis Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.41 Omron Healthcare Co Ltd Company Overview 90

5.41.1 Omron Healthcare Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

5.42 Omron Healthcare Inc Company Overview 91

5.42.1 Omron Healthcare Inc Pipeline Products & Ongoing Clinical Trials Overview 91

5.43 OncoSec Medical Inc Company Overview 92

5.43.1 OncoSec Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.44 PARI GmbH Company Overview 93

5.44.1 PARI GmbH Pipeline Products & Ongoing Clinical Trials Overview 93

5.45 Parion Sciences Inc Company Overview 94

5.45.1 Parion Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.46 Pharmosa Biopharm Inc Company Overview 95

5.46.1 Pharmosa Biopharm Inc Pipeline Products & Ongoing Clinical Trials Overview 95

5.47 Respira Technologies Inc Company Overview 99

5.47.1 Respira Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 99

5.48 Rhinomed Ltd Company Overview 100

5.48.1 Rhinomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 100

5.49 Risproly Company Overview 102

5.49.1 Risproly Pipeline Products & Ongoing Clinical Trials Overview 102

5.50 RMIT University Company Overview 104

5.50.1 RMIT University Pipeline Products & Ongoing Clinical Trials Overview 104

5.51 Rutgers Cancer Institute of New Jersey Company Overview 105

5.51.1 Rutgers Cancer Institute of New Jersey Pipeline Products & Ongoing Clinical Trials Overview 105

5.52 Sandoz International GmbH Company Overview 106

5.52.1 Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 106

5.53 Shenzhen Smoore Technology Ltd Company Overview 107

5.53.1 Shenzhen Smoore Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

5.54 Sino Biopharmaceutical Ltd Company Overview 108

5.54.1 Sino Biopharmaceutical Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

5.55 SolAeroMed Inc Company Overview 111

5.55.1 SolAeroMed Inc Pipeline Products & Ongoing Clinical Trials Overview 111

5.56 Stevanato Group Company Overview 112

5.56.1 Stevanato Group Pipeline Products & Ongoing Clinical Trials Overview 112

5.57 Stirling Pharma Inc Company Overview 113

5.57.1 Stirling Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 113

5.58 Suzhou Wulian Medical Technology Co Ltd Company Overview 114

5.58.1 Suzhou Wulian Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

5.59 Technology Commercialization Partners LLC Company Overview 115

5.59.1 Technology Commercialization Partners LLC Pipeline Products & Ongoing Clinical Trials Overview 115

5.60 Teleflex Inc Company Overview 116

5.60.1 Teleflex Inc Pipeline Products & Ongoing Clinical Trials Overview 116

5.61 Tetra Bio-Pharma Inc Company Overview 117

5.61.1 Tetra Bio-Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 117

5.62 Teva Pharmaceutical Industries Ltd Company Overview 118

5.62.1 Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 118

5.63 Texas Tech University Health Sciences Center Company Overview 120

5.63.1 Texas Tech University Health Sciences Center Pipeline Products & Ongoing Clinical Trials Overview 120

5.64 Third Pole Inc Company Overview 121

5.64.1 Third Pole Inc Pipeline Products & Ongoing Clinical Trials Overview 121

5.65 Tiziana Life Sciences PLC Company Overview 123

5.65.1 Tiziana Life Sciences PLC Pipeline Products & Ongoing Clinical Trials Overview 123

5.66 University Hospital Southampton NHS Foundation Trust Company Overview 124

5.66.1 University Hospital Southampton NHS Foundation Trust Pipeline Products & Ongoing Clinical Trials Overview 124

5.67 University of California San Diego Company Overview 127

5.67.1 University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 127

5.68 University of Texas Health Science Center at Houston Company Overview 128

5.68.1 University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 128

5.69 University of Texas Medical Branch at Galveston Company Overview 129

5.69.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 129

5.70 Vectura Group Plc Company Overview 130

5.70.1 Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 130

5.71 Veoli Ltd Company Overview 135

5.71.1 Veoli Ltd Pipeline Products & Ongoing Clinical Trials Overview 135

5.72 Vero Biotech LLC Company Overview 136

5.72.1 Vero Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 136

5.73 Verona Pharma Plc Company Overview 139

5.73.1 Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 139

5.74 Via Therapeutics LLC Company Overview 141

5.74.1 Via Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 141

5.75 Vincent Medical Holdings Ltd Company Overview 142

5.75.1 Vincent Medical Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 142

5.76 Virpax Pharmaceuticals Inc Company Overview 143

5.76.1 Virpax Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 143

5.77 VistaGen Therapeutics Inc Company Overview 144

5.77.1 VistaGen Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 144

5.78 VitalMIST Company Overview 148

5.78.1 VitalMIST Pipeline Products & Ongoing Clinical Trials Overview 148

5.79 Wellfully Ltd Company Overview 149

5.79.1 Wellfully Ltd Pipeline Products & Ongoing Clinical Trials Overview 149

5.80 Wellinks Inc Company Overview 150

5.80.1 Wellinks Inc Pipeline Products & Ongoing Clinical Trials Overview 150

5.81 Windtree Therapeutics Inc Company Overview 153

5.81.1 Windtree Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 153

6 Inhalable Drug Delivery- Recent Developments 156

6.1 Aug 29, 2023: Inhalation Sciences Releases Q2 Report 2023 156

6.2 Aug 07, 2023: Windtree Therapeutics Reports Second Quarter 2023 Financial Results and Provides Key Business Updates 159

6.3 Aug 03, 2023: Monash pharmacy Educator Steps into New Leadership Roles 160

6.4 Jun 28, 2023: Inhalation Sciences Wins New Purchase Order From Asian Distributor Worth 94,000 USD 161

6.5 May 12, 2023: Impel Pharmaceuticals announces first quarter 2023 financial results and provides business update 161

6.6 Apr 12, 2023: Impel Pharmaceuticals Announces Appointment of Darren Cline to the Board of Directors 163

6.7 Apr 11, 2023: Inhalation Sciences releases Annual Report 2022 including Audit Report 163

6.8 Mar 31, 2023: Bellerophon Provides Clinical Program Update and Reports Full-Year 2022 Financial Results 163

6.9 Mar 29, 2023: Baxter to Host Annual Meeting of Stockholders in Virtual Format 165

6.10 Mar 24, 2023: Impel Pharmaceuticals Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update 165

6.11 Mar 17, 2023: Impel Pharmaceuticals to Report Fourth Quarter and Full Year 2022 Financial Results on Friday, March 24, 2023 167

6.12 Mar 07, 2023: AstraZeneca Notice of AGM 167

6.13 Mar 06, 2023: Catalent Appoints Sridhar Krishnan to Lead New Global Operational Excellence Strategy, “The Catalent Way” 168

6.14 Feb 15, 2023: Syqe Medical Announces Agreement with Israeli Ministry of Defence to Provide the SyqeAir Technology to Veterans 169

6.15 Feb 09, 2023: Baxter Reports Fourth-Quarter and Full-Year 2022 Results 169

6.16 Feb 09, 2023: AstraZeneca Announces Final Results 172

6.17 Dec 30, 2022: AstraZeneca : Director/PDMR Shareholding 172

6.18 Dec 26, 2022: Sunovion Plans To Lay Off 360 Employees in 2023 173

6.19 Dec 23, 2022: Inhalation Sciences signs R&D order worth 257,000 SEK with major generic pharma company 173

6.20 Nov 14, 2022: Bellerophon Provides Clinical Program Update and Reports Third Quarter 2022 Financial Results 174

6.21 Sep 30, 2022: AstraZeneca announces Remuneration committee chair appointment 175

6.22 Sep 21, 2022: Windtree to Present at the Ladenburg Thalmann Healthcare Conference 176

6.23 Sep 19, 2022: Catalent Appoints Karen Santiago as Vice President and Chief Accounting Officer 176

7 Appendix 177

7.1 Methodology 177

7.2 About GlobalData 180

7.3 Contact Us 180

7.4 Disclaimer 180

Table

Inhalable Drug Delivery – Pipeline Products by Stage of Development 16

Inhalable Drug Delivery – Pipeline Products by Segment 17

Inhalable Drug Delivery – Pipeline Products by Territory 18

Inhalable Drug Delivery – Pipeline Products by Regulatory Path 20

Inhalable Drug Delivery – Pipeline Products by Estimated Approval Date 21

Inhalable Drug Delivery – Ongoing Clinical Trials 22

Inhalable Drug Delivery Companies – Pipeline Products by Stage of Development 23

Inhalable Drug Delivery – Pipeline Products by Stage of Development 27

Ablynx NV Pipeline Products & Ongoing Clinical Trials Overview 30

Customised Infant Inhalation Device – Product Status 30

Customised Infant Inhalation Device – Product Description 30

Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 31

Drug Delivery Device – Neonatal Respiratory Distress Syndrome (RDS) – Product Status 31

Drug Delivery Device – Neonatal Respiratory Distress Syndrome (RDS) – Product Description 31

Actervis GmbH Pipeline Products & Ongoing Clinical Trials Overview 32

Inhaluxe – Product Status 32

Inhaluxe – Product Description 32

Aeon Research & Technology Pipeline Products & Ongoing Clinical Trials Overview 33

LYNX Nebulizer – Product Status 33

LYNX Nebulizer – Product Description 33

Aerami Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 34

FOX Mesh Nebulizer – Product Status 34

FOX Mesh Nebulizer – Product Description 34

Aerophase Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Aerosol-Delivery System – Lung Cancer – Product Status 35

Aerosol-Delivery System – Lung Cancer – Product Description 35

AFT Pharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

NasoSURF – Product Status 36

NasoSURF – Product Description 36

AFT Pharmaceuticals Ltd – Ongoing Clinical Trials Overview 37

NasoSURF – Pharmacokinetics and Pharmacodynamics of Midazolam Administered Intranasally Using the Nasosurf Device to Healthy Volunteers 38

Alexza Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Staccato Fentanyl Inhalation System – Product Status 39

Staccato Fentanyl Inhalation System – Product Description 39

Ayuda Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 40

Dual Sensor Regional Oximeter – Product Status 40

Dual Sensor Regional Oximeter – Product Description 40

Baby’s Breath Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

WiseAir – Product Status 41

WiseAir – Product Description 41

Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 42

ProMaxx Microsphere – Product Status 42

ProMaxx Microsphere – Product Description 42

Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 43

INOpulse – Product Status 43

INOpulse – Product Description 43

Bellerophon Therapeutics Inc – Ongoing Clinical Trials Overview 44

INOpulse – A Phase 3 Study to INOpulse for the Treatment of Fibrotic Interstitial Lung Disease 45

INOpulse – A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2) 45

INOpulse – An Open-label Long-term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO Therapy 45

INOpulse – Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension 46

INOpulse – INOvation-2 Clinical Study of INOpulse Device 46

INOpulse – Phase IIb Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects in Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease (PH-COPD) 46

INOpulse – Pivotal Phase 3 Study Evaluate the INOpulse for the Treatment of Pulmonary Hypertension Associated with Pulmonary Fibrosis 47

Breath Therapeutics Holding BV Pipeline Products & Ongoing Clinical Trials Overview 48

Lung-Targeted BOS Device – Product Status 48

Lung-Targeted BOS Device – Product Description 48

Breath Therapeutics Holding BV – Ongoing Clinical Trials Overview 49

Lung-Targeted BOS Device – A Phase IIa Multi-center, Randomized, Single-blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation 50

Lung-Targeted BOS Device – A Phase III Clinical Trial to Demonstrate Efficacy / Safety of Liposomal Cyclosporine A + Standard of Care (SoC) vs SoC Alone in Treating Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans in Patients Post Double Lung Transplant 50

Lung-Targeted BOS Device – A Phase III Clinical Trial to Demonstrate Efficacy / Safety of Liposomal Cyclosporine A + Standard of Care (SoC) vs SoC Alone in Treating Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans in Patients Post Single Lung Transplant 50

Lung-Targeted BOS Device – A Phase III, Extension Clinical Trial to Demonstrate Efficacy and Safety of Liposomal Cyclosprine A Via the PARI Investigational eFlow Device and SoC in Treating Bronchiolitis Obliterans in Patients Post Single or Double Lung Transplant 51

Bridgesource Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 52

Breath-Adaptive Nebulizer – Product Status 52

Breath-Adaptive Nebulizer – Product Description 52

California Northstate University College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 53

Drug Delivery System – PAH – Product Status 53

Drug Delivery System – PAH – Product Description 53

Canigma A.L LTD Pipeline Products & Ongoing Clinical Trials Overview 54

Vaporiser Device – Product Status 54

Vaporiser Device – Product Description 54

Cognigenics Inc Pipeline Products & Ongoing Clinical Trials Overview 55

CRISPR/Cas9 Delivery System – Product Status 55

CRISPR/Cas9 Delivery System – Product Description 55

Creare LLC Pipeline Products & Ongoing Clinical Trials Overview 56

DDC-Based Nebulizer – Product Status 56

DDC-Based Nebulizer – Product Description 56

Cybin Inc Pipeline Products & Ongoing Clinical Trials Overview 57

Drug Delivery Device – Product Status 57

Drug Delivery Device – Product Description 57

Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 58

Hava – Product Status 58

Hava – Product Description 58

DesignWise Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 59

Self-Contained Nebulizer System – Product Status 59

Self-Contained Nebulizer System – Product Description 59

Edixomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

NOx System – VAP – Product Status 60

NOx System – VAP – Product Description 60

HCmed Innovations Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 61

AdheResp – Product Status 61

AdheResp – Product Description 61

HOLLO Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 62

Inhaler Spacer – Product Status 62

Inhaler Spacer – Product Description 62

iDTx Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63

GoPilot – Product Status 63

GoPilot – Product Description 63

Impel Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 64

INP105 – Product Status 64

INP105 – Product Description 64

INP107 – Product Status 65

INP107 – Product Description 65

Impel Pharmaceuticals Inc – Ongoing Clinical Trials Overview 66

INP105 – A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Single Dose, 2-Way, 2-Period Crossover Safety and Exploratory Efficacy Study of INP105 (POD-OLZ) for the Acute Treatment of Agitation in Adolescents and Young Adults With Autism Spectrum Disorder 67

Inhalation Sciences Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 68

PreciseInhale System – Product Status 68

PreciseInhale System – Product Description 68

Inhalation Sciences Sweden AB – Ongoing Clinical Trials Overview 69

PreciseInhale System – A Clinical Validation Study of PreciseInhale System in Healthy Volunteers 70

Invero Pharma LLC Pipeline Products & Ongoing Clinical Trials Overview 71

XENEX – Product Status 71

XENEX – Product Description 71

Jupiter Research LLC Pipeline Products & Ongoing Clinical Trials Overview 72

Jupiter Liquid9 Vaporizer – Product Status 72

Jupiter Liquid9 Vaporizer – Product Description 72

KAER Biotherapeutics Corp Pipeline Products & Ongoing Clinical Trials Overview 73

SUPRAER-Mini – Product Status 73

SUPRAER-Mini – Product Description 73

Kanabo Research Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

Next Generation Smart VapePod MD Vaporizer – Product Status 74

Next Generation Smart VapePod MD Vaporizer – Product Description 74

VapePod – Product Status 75

VapePod – Product Description 75

Kanabo Research Ltd – Ongoing Clinical Trials Overview 76

VapePod – Study to Evaluate the Bioavailability and Efficacy for Kanabo’s Cannabis Inhalation Formulas in Conjunction with VapePod 77

Lupin Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 78

Soft-Mist Inhalation Device – Product Status 78

Soft-Mist Inhalation Device – Product Description 78

Mallinckrodt Plc Pipeline Products & Ongoing Clinical Trials Overview 79

Next Generation Inomax Evolve – Product Status 79

Next Generation Inomax Evolve – Product Description 79

Marquette University Pipeline Products & Ongoing Clinical Trials Overview 80

Human Powered Nebulizer – Product Status 80

Human Powered Nebulizer – Product Description 80

Medspray BV Pipeline Products & Ongoing Clinical Trials Overview 81

Device 0075 – Product Status 81

Device 0075 – Product Description 81

Product 0070 – Product Status 82

Product 0070 – Product Description 82

Product 0077 – Product Status 82

Product 0077 – Product Description 83

Monash University Pipeline Products & Ongoing Clinical Trials Overview 84

High-Flow Nebuliser – Product Status 84

High-Flow Nebuliser – Product Description 84

Nebuliser – Product Status 85

Nebuliser – Product Description 85

Nemera La Verpilliere Pipeline Products & Ongoing Clinical Trials Overview 86

CUPIDO – Product Status 86

CUPIDO – Product Description 86

Next Safety, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87

Pulmonary Drug Delivery Device – Product Status 87

Pulmonary Drug Delivery Device – Product Description 87

Nob Hill Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 88

DryNeb – Product Status 88

DryNeb – Product Description 88

Nobilis Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 89

Zephyrus – Product Status 89

Zephyrus – Product Description 89

Omron Healthcare Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

Avt – Product Status 90

Avt – Product Description 90

Omron Healthcare Inc Pipeline Products & Ongoing Clinical Trials Overview 91

Neko Cat – Product Status 91

Neko Cat – Product Description 91

OncoSec Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 92

NeoPulse – Skin Cancer – Product Status 92

NeoPulse – Skin Cancer – Product Description 92

PARI GmbH Pipeline Products & Ongoing Clinical Trials Overview 93

Vibrating Mesh Nebulizer For RespiraClear – Product Status 93

Vibrating Mesh Nebulizer For RespiraClear – Product Description 93

Parion Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 94

tPAD Device – Product Status 94

tPAD Device – Product Description 94

Pharmosa Biopharm Inc Pipeline Products & Ongoing Clinical Trials Overview 95

L606 Inhalation System – Product Status 95

L606 Inhalation System – Product Description 95

L608 Inhalation System – Product Status 96

L608 Inhalation System – Product Description 96

Pharmosa Biopharm Inc – Ongoing Clinical Trials Overview 97

L606 Inhalation System – A Phase 3, 2-Part, Open-Label Study to Evaluate the Safety and Tolerability of Liposomal Treprostinil Inhalation Suspension (L606) in Subjects With Pulmonary Arterial Hypertension or Pulmonary Hypertension Associated With Interstitial Lung Disease 98

Respira Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 99

RespiRx – Nicotine Replacement Therapy (NRT) – Product Status 99

RespiRx – Nicotine Replacement Therapy (NRT) – Product Description 99

Rhinomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 100

Pronto Anxiety – Product Status 100

Pronto Anxiety – Product Description 100

Pronto Migraine – Product Status 101

Pronto Migraine – Product Description 101

Pronto Sleep Plus – Product Status 101

Pronto Sleep Plus – Product Description 101

Risproly Pipeline Products & Ongoing Clinical Trials Overview 102

Drug Delivery Device – Asthma – Product Status 102

Drug Delivery Device – Asthma – Product Description 102

Drug Delivery Device – CNS Disease – Product Status 103

Drug Delivery Device – CNS Disease – Product Description 103

Drug Delivery Device – COPD – Product Status 103

Drug Delivery Device – COPD – Product Description 103

RMIT University Pipeline Products & Ongoing Clinical Trials Overview 104

UAS Nebulizer – Product Status 104

UAS Nebulizer – Product Description 104

Rutgers Cancer Institute of New Jersey Pipeline Products & Ongoing Clinical Trials Overview 105

Pulmonary Drug Delivery System – Product Status 105

Pulmonary Drug Delivery System – Product Description 105

Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 106

FreePath Drug Delivery System – Product Status 106

FreePath Drug Delivery System – Product Description 106

Shenzhen Smoore Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

Inhalation Delivery Device – Product Status 107

Inhalation Delivery Device – Product Description 107

Sino Biopharmaceutical Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

SFT-1001 – Product Status 108

SFT-1001 – Product Description 108

SFT-1002 – Product Status 109

SFT-1002 – Product Description 109

SFT-1003 – Product Status 109

SFT-1003 – Product Description 110

SFT-1004 – Product Status 110

SFT-1004 – Product Description 110

SolAeroMed Inc Pipeline Products & Ongoing Clinical Trials Overview 111

S1226 Neublizer System – Product Status 111

S1226 Neublizer System – Product Description 111

Stevanato Group Pipeline Products & Ongoing Clinical Trials Overview 112

Alba Integrated PFSI – Product Status 112

Alba Integrated PFSI – Product Description 112

Stirling Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 113

High Density Aerosol Drug Delivery Device – Product Status 113

High Density Aerosol Drug Delivery Device – Product Description 113

Suzhou Wulian Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

Nebulization Drug Delivery Device – Product Status 114

Nebulization Drug Delivery Device – Product Description 114

Technology Commercialization Partners LLC Pipeline Products & Ongoing Clinical Trials Overview 115

iNO Delivery System – Product Status 115

iNO Delivery System – Product Description 115

Teleflex Inc Pipeline Products & Ongoing Clinical Trials Overview 116

Turbomist – Product Status 116

Turbomist – Product Description 116

Tetra Bio-Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 117

CAUMZ-Kit – Product Status 117

CAUMZ-Kit – Product Description 117

Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 118

Digihaler – Product Status 118

Digihaler – Product Description 118

QVAR Digihaler – Product Status 119

QVAR Digihaler – Product Description 119

Texas Tech University Health Sciences Center Pipeline Products & Ongoing Clinical Trials Overview 120

Inhalable Nanoparticle System – Product Status 120

Inhalable Nanoparticle System – Product Description 120

Third Pole Inc Pipeline Products & Ongoing Clinical Trials Overview 121

eNOcare – Product Status 121

eNOcare – Product Description 121

eNOfit – Product Status 122

eNOfit – Product Description 122

Tiziana Life Sciences PLC Pipeline Products & Ongoing Clinical Trials Overview 123

Nasal Drug Delivery Device – Product Status 123

Nasal Drug Delivery Device – Product Description 123

University Hospital Southampton NHS Foundation Trust Pipeline Products & Ongoing Clinical Trials Overview 124

Covsurf Drug Delivery System – Product Status 124

Covsurf Drug Delivery System – Product Description 124

University Hospital Southampton NHS Foundation Trust – Ongoing Clinical Trials Overview 125

Covsurf Drug Delivery System – A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19 126

University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 127

Nebulizer – Product Status 127

Nebulizer – Product Description 127

University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 128

Pedinap – Product Status 128

Pedinap – Product Description 128

University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 129

Pulse Drug Nebulization System – Product Status 129

Pulse Drug Nebulization System – Product Description 129

Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 130

FOX Vibrating Mesh Nebulizer – Product Status 130

FOX Vibrating Mesh Nebulizer – Product Description 130

VR475 Combination Device – Product Status 131

VR475 Combination Device – Product Description 131

VR647 – Product Status 131

VR647 – Product Description 132

Vectura Group Plc – Ongoing Clinical Trials Overview 133

VR647 – A Phase I Clinical Study of VR-647 134

VR647 – A Phase I Clinical Study of VR-647 in Adult Asthma Subjects 134

VR647 – Phase II Pharmacokinetic Study of VR-647 in Children 134

VR647 – Phase III Study of VR-647 134

Veoli Ltd Pipeline Products & Ongoing Clinical Trials Overview 135

Cannabis Inhaler Device – Product Status 135

Cannabis Inhaler Device – Product Description 135

Vero Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 136

GeNOsyl Acute DS – Product Status 136

GeNOsyl Acute DS – Product Description 136

GeNOSYL Chronic DS – Product Status 137

GeNOSYL Chronic DS – Product Description 137

NITROSYL System – Product Status 137

NITROSYL System – Product Description 138

Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 139

Ensifentrine + LAMA Nebulizer – Product Status 139

Ensifentrine + LAMA Nebulizer – Product Description 139

RPL554 Nebulizer – Product Status 140

RPL554 Nebulizer – Product Description 140

Via Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 141

Inhaled Delivery System – Product Status 141

Inhaled Delivery System – Product Description 141

Vincent Medical Holdings Ltd Pipeline Products & Ongoing Clinical Trials Overview 142

Home Use Ultrasonic Nebulizer – Product Status 142

Home Use Ultrasonic Nebulizer – Product Description 142

Virpax Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 143

NES100 – Product Status 143

NES100 – Product Description 143

VistaGen Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 144

PH94B Neuroactive Nasal Spray – Product Status 144

PH94B Neuroactive Nasal Spray – Product Description 145

VistaGen Therapeutics Inc – Ongoing Clinical Trials Overview 146

PH94B Neuroactive Nasal Spray – A Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Tolerability of the Acute Administration of Fasedienol to Relieve Anxiety Symptoms in Adult Subjects with SAD 147

VitalMIST Pipeline Products & Ongoing Clinical Trials Overview 148

VitalMIST – Product Status 148

VitalMIST – Product Description 148

Wellfully Ltd Pipeline Products & Ongoing Clinical Trials Overview 149

Nebulizer – Product Status 149

Nebulizer – Product Description 149

Wellinks Inc Pipeline Products & Ongoing Clinical Trials Overview 150

Bluetooth Enabled Flyp Nebulizer – Product Status 150

Bluetooth Enabled Flyp Nebulizer – Product Description 150

Wellinks Inc – Ongoing Clinical Trials Overview 151

Bluetooth Enabled Flyp Nebulizer – POWER: Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions 152

Windtree Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 153

Aerosol Drug Delivery Device – COVID-19 Associated Lung Injury (KL4 Platform) – Product Status 153

Aerosol Drug Delivery Device – COVID-19 Associated Lung Injury (KL4 Platform) – Product Description 153

AEROSURF – Product Status 154

AEROSURF – Product Description 154

Capillary Aerosol Generator (CAG) – Product Status 155

Capillary Aerosol Generator (CAG) – Product Description 155

Glossary 179

Figures

Inhalable Drug Delivery – Pipeline Products by Stage of Development 16

Inhalable Drug Delivery – Pipeline Products by Segment 17

Inhalable Drug Delivery – Pipeline Products by Territory 18

Inhalable Drug Delivery – Pipeline Products by Regulatory Path 20

Inhalable Drug Delivery – Pipeline Products by Estimated Approval Date 21

Inhalable Drug Delivery – Ongoing Clinical Trials 22

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