Inhalable Drug Delivery Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

Pages: 173 Published: June 24, 2022 Report Code: GDME1393EPD

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 which are in progress.

What is the territory outlook in the inhalable drug delivery pipeline products market?

The US, Europe, China, India, Canada, South Korea, Thailand, the UK, Vietnam, Taiwan, Singapore, Malaysia, Australia, Brazil, Indonesia, Israel, Japan, Kosovo, Lebanon, Macau, Malawi, Iran, Iraq, Andorra, Greece, Hong Kong, Germany, Malta, Montenegro, Morocco, New Zealand, North Macedonia, Oman, Philippines, Russia, Serbia, and Zambia have products in the pipeline. As of June 2022, the US has the highest number of products in the pipeline out of them all.

Inhalable drug delivery pipeline products market, by territory

Inhalable drug delivery pipeline products market, by territory

For more territory insights, download a free report sample

What are the key segments in the inhalable drug delivery pipeline products market?

The key segments in the inhalable drug delivery pipeline products market are nebulizer systems and aqueous systems. Nebulizer systems dominate the market.

Inhalable drug delivery pipeline products market, by key segments

Inhalable drug delivery pipeline products market, by key segments

For more key segment insights, download a free report sample

What are the regulatory paths for the inhalable drug delivery pipeline products market?

Some of the regulatory path followed by the inhalable drug delivery pipeline products are 510(k), CE, NMPA, ICAC, MDITAC, MDL, Ninsho, MDA, ANVISA, and BOPA. The majority of products follow the 510(k) pathway to enter the market.

Inhalable drug delivery pipeline products market, by regulatory path

Inhalable drug delivery pipeline products market, by regulatory path

For more regulatory path insights, download a free report sample

What are the key companies in the inhalable drug delivery pipeline products market?

Some of the key companies in the inhalable drug delivery market are Acerus Pharmaceuticals Corp, Acorda Therapeutics Inc, Aerami Therapeutics Inc, Actervis GmbH, Aerophase Inc, Alexza Pharmaceuticals Inc, Baxter International Inc, Bellerophon Therapeutics Inc, Breath Therapeutics Holding BV, and California Northstate University College of Medicine.

Acerus Pharmaceuticals Corp

Acerus Pharmaceuticals Corp (Acerus) develops, manufactures, markets, and distributes novel innovative branded products. It focuses on the therapeutic areas of women’s health. The company sells products through its salesforce in Canada and licensed distributors in the US and other countries. The company is headquartered in Mississauga, Ontario, Canada.

Acorda Therapeutics Inc

Acorda Therapeutics Inc (Acorda) is a biopharmaceutical company that discovers, develops, and markets therapies for treating patients with neurological disorders. The company sells its products through wholesale pharmaceutical distributors to retail pharmacies and specialty pharmacy providers. It has subsidiaries in the US and Europe. Acorda is headquartered in Ardsley, New York, the US.

Aerami Therapeutics Inc

Aerami Therapeutics Inc (Aerami) is a biotechnology company that develops inhaled insulin products to treat diabetes patients. The company develops liquid formulation of insulin based on the vibrating mesh micropump technology developed and commercialized by Aerogen. Aerami is headquartered in San Francisco, California, the US.

Market report scope

Key territories The US, Europe, China, India, Canada, South Korea, Thailand, the UK, Vietnam, Taiwan, Singapore, Malaysia, Australia, Brazil, Indonesia, Israel, Japan, Kosovo, Lebanon, Macau, Malawi, Iran, Iraq, Andorra, Greece, Hong Kong, Germany, Malta, Montenegro, Morocco, New Zealand, North Macedonia, Oman, Philippines, Russia, Serbia, and Zambia
Key segments Nebulizer Systems and Aqueous Systems
Key regulatory paths 510(k), CE, NMPA, ICAC, MDITAC, MDL, Ninsho, MDA, ANVISA, and BOPA
Key companies Acerus Pharmaceuticals Corp, Acorda Therapeutics Inc, Aerami Therapeutics Inc, Actervis GmbH, Aerophase Inc, Alexza Pharmaceuticals Inc, Baxter International Inc, Bellerophon Therapeutics Inc, Breath Therapeutics Holding BV, and California Northstate University College of Medicine

This report provides:

  • Extensive coverage of the Inhalable drug delivery under development.
  • Details of major pipeline products which includes product description, licensing, and collaboration details and other developmental activities.
  • Reviews of the major players involved in the development of Inhalable drug delivery and lists all their pipeline projects.
  • The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage.
  • 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 portfolio and create effective counterstrategies 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.

Key Players

Acorda Therapeutics Inc

Actervis GmbH

Aerami Therapeutics Inc

Aerophase Inc

Alexza Pharmaceuticals Inc

Atossa Therapeutics Inc

Baxter International Inc

Bellerophon Therapeutics Inc

Breath Therapeutics Holding BV

California Northstate University College of Medicine

Canigma A.L LTD

Edixomed Ltd

Engage Therapeutics Inc

iDTx Systems, Inc.

Impel NeuroPharma Inc

Inhalation Sciences Sweden AB

InhaleRx Ltd

Invero Pharma LLC

Jupiter Research LLC

Kanabo Research Ltd

Mallinckrodt Plc

Medical Developments International Ltd

Medspray BV

Monash University

Nemera La Verpilliere

Next Safety, Inc.

Nobilis Therapeutics Inc

OncoSec Medical Inc

Parnell Pharmaceuticals Inc

Pharmosa Biopharm Inc

Rhinomed Limited

Rutgers Cancer Institute of New Jersey

Sandoz International GmbH

Seng Vital International GmbH

Shenzhen Smoore Technology Ltd

Technology Commercialization Partners LLC

Tetra Bio-Pharma Inc

Teva Pharmaceutical Industries Ltd

Texas Tech University Health Sciences Center

Third Pole Inc

Tiziana Life Sciences PLC

Torrent Pharmaceuticals Ltd

University Hospital Southampton NHS Foundation Trust

University of Texas Health Science Center at Houston

Vectura Group Plc

Veoli Ltd

Vero Biotech LLC

Via Therapeutics LLC

Virpax Pharmaceuticals Inc

VistaGen Therapeutics Inc

VitalMIST

Windtree Therapeutics Inc

Table of Contents

1 Table of Contents 3

|1.1 List of Tables 7

|1.2 List of Figures 13

2 Introduction 14

2.1 Inhalable Drug Delivery Overview 14

3 Products under Development 15

3.1 Inhalable Drug Delivery – Pipeline Products by Stage of Development 15

3.2 Inhalable Drug Delivery – Pipeline Products by Segment 16

3.3 Inhalable Drug Delivery – Pipeline Products by Territory 17

3.4 Inhalable Drug Delivery – Pipeline Products by Regulatory Path 19

3.5 Inhalable Drug Delivery – Pipeline Products by Estimated Approval Date 20

3.6 Inhalable Drug Delivery – Ongoing Clinical Trials 21

4 Inhalable Drug Delivery – Pipeline Products under Development by Companies 22

4.1 Inhalable Drug Delivery Companies – Pipeline Products by Stage of Development 22

4.2 Inhalable Drug Delivery – Pipeline Products by Stage of Development 25

5 Inhalable Drug Delivery Companies and Product Overview 28

5.1 Acerus Pharmaceuticals Corp Company Overview 28

5.1.1 Acerus Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 28

5.2 Acorda Therapeutics Inc Company Overview 29

5.2.1 Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 29

5.3 Actervis GmbH Company Overview 30

5.3.1 Actervis GmbH Pipeline Products & Ongoing Clinical Trials Overview 30

5.4 Aerami Therapeutics Inc Company Overview 31

5.4.1 Aerami Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.5 Aerophase Inc Company Overview 32

5.5.1 Aerophase Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.6 Alexza Pharmaceuticals Inc Company Overview 33

5.6.1 Alexza Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.7 Baxter International Inc Company Overview 34

5.7.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.8 Bellerophon Therapeutics Inc Company Overview 35

5.8.1 Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.9 Breath Therapeutics Holding BV Company Overview 39

5.9.1 Breath Therapeutics Holding BV Pipeline Products & Ongoing Clinical Trials Overview 39

5.10 California Northstate University College of Medicine Company Overview 43

5.10.1 California Northstate University College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 43

5.11 Canigma A.L LTD Company Overview 44

5.11.1 Canigma A.L LTD Pipeline Products & Ongoing Clinical Trials Overview 44

5.12 Cipla Ltd Company Overview 45

5.12.1 Cipla Ltd Pipeline Products & Ongoing Clinical Trials Overview 45

5.13 Department of Biomedical Engineering Columbia University Company Overview 47

5.13.1 Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 47

5.14 Edixomed Ltd Company Overview 48

5.14.1 Edixomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

5.15 Engage Therapeutics Inc Company Overview 49

5.15.1 Engage Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.16 iDTx Systems, Inc. Company Overview 50

5.16.1 iDTx Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50

5.17 Impel Pharmaceuticals Inc Company Overview 51

5.17.1 Impel Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.18 Inhalation Sciences Sweden AB Company Overview 55

5.18.1 Inhalation Sciences Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 55

5.19 Invero Pharma LLC Company Overview 59

5.19.1 Invero Pharma LLC Pipeline Products & Ongoing Clinical Trials Overview 59

5.20 Jupiter Research LLC Company Overview 62

5.20.1 Jupiter Research LLC Pipeline Products & Ongoing Clinical Trials Overview 62

5.21 Kanabo Research Ltd Company Overview 63

5.21.1 Kanabo Research Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

5.22 Lupin Pharmaceuticals Inc Company Overview 67

5.22.1 Lupin Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 67

5.23 Mallinckrodt Plc Company Overview 68

5.23.1 Mallinckrodt Plc Pipeline Products & Ongoing Clinical Trials Overview 68

5.24 Medical Developments International Ltd Company Overview 69

5.24.1 Medical Developments International Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

5.25 Medspray BV Company Overview 75

5.25.1 Medspray BV Pipeline Products & Ongoing Clinical Trials Overview 75

5.26 Monash University Company Overview 78

5.26.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 78

5.27 Nemera La Verpilliere Company Overview 79

5.27.1 Nemera La Verpilliere Pipeline Products & Ongoing Clinical Trials Overview 79

5.28 Next Safety, Inc. Company Overview 80

5.28.1 Next Safety, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80

5.29 Nobilis Therapeutics Inc Company Overview 81

5.29.1 Nobilis Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 81

5.30 OncoSec Medical Inc Company Overview 84

5.30.1 OncoSec Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 84

5.31 Pharmosa Biopharm Inc Company Overview 85

5.31.1 Pharmosa Biopharm Inc Pipeline Products & Ongoing Clinical Trials Overview 85

5.32 Rhinomed Ltd Company Overview 89

5.32.1 Rhinomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

5.33 Risproly Company Overview 92

5.33.1 Risproly Pipeline Products & Ongoing Clinical Trials Overview 92

5.34 Rutgers Cancer Institute of New Jersey Company Overview 95

5.34.1 Rutgers Cancer Institute of New Jersey Pipeline Products & Ongoing Clinical Trials Overview 95

5.35 Sandoz International GmbH Company Overview 96

5.35.1 Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 96

5.36 Seng Vital International GmbH Company Overview 97

5.36.1 Seng Vital International GmbH Pipeline Products & Ongoing Clinical Trials Overview 97

5.37 Shenzhen Smoore Technology Ltd Company Overview 99

5.37.1 Shenzhen Smoore Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

5.38 Sino Biopharmaceutical Ltd Company Overview 100

5.38.1 Sino Biopharmaceutical Ltd Pipeline Products & Ongoing Clinical Trials Overview 100

5.39 Technology Commercialization Partners LLC Company Overview 104

5.39.1 Technology Commercialization Partners LLC Pipeline Products & Ongoing Clinical Trials Overview 104

5.40 Tetra Bio-Pharma Inc Company Overview 105

5.40.1 Tetra Bio-Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 105

5.41 Teva Pharmaceutical Industries Ltd Company Overview 106

5.41.1 Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

5.42 Texas Tech University Health Sciences Center Company Overview 108

5.42.1 Texas Tech University Health Sciences Center Pipeline Products & Ongoing Clinical Trials Overview 108

5.43 Third Pole Inc Company Overview 110

5.43.1 Third Pole Inc Pipeline Products & Ongoing Clinical Trials Overview 110

5.44 Tiziana Life Sciences PLC Company Overview 112

5.44.1 Tiziana Life Sciences PLC Pipeline Products & Ongoing Clinical Trials Overview 112

5.45 Torrent Pharmaceuticals Ltd Company Overview 113

5.45.1 Torrent Pharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 113

5.46 University Hospital Southampton NHS Foundation Trust Company Overview 114

5.46.1 University Hospital Southampton NHS Foundation Trust Pipeline Products & Ongoing Clinical Trials Overview 114

5.47 University of Texas Health Science Center at Houston Company Overview 117

5.47.1 University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 117

5.48 Vectura Group Plc Company Overview 118

5.48.1 Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 118

5.49 Veoli Ltd Company Overview 123

5.49.1 Veoli Ltd Pipeline Products & Ongoing Clinical Trials Overview 123

5.50 Vero Biotech LLC Company Overview 124

5.50.1 Vero Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 124

5.51 Via Therapeutics LLC Company Overview 127

5.51.1 Via Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 127

5.52 Virpax Pharmaceuticals Inc Company Overview 128

5.52.1 Virpax Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 128

5.53 VistaGen Therapeutics Inc Company Overview 129

5.53.1 VistaGen Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 129

5.54 VitalMIST Company Overview 133

5.54.1 VitalMIST Pipeline Products & Ongoing Clinical Trials Overview 133

5.55 Wellfully Ltd Company Overview 134

5.55.1 Wellfully Ltd Pipeline Products & Ongoing Clinical Trials Overview 134

5.56 Windtree Therapeutics Inc Company Overview 135

5.56.1 Windtree Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 135

6 Inhalable Drug Delivery- Recent Developments 138

6.1 Jun 20, 2022: Appointment of Ms Susanne Williamson as Chief Philanthropy Officer of Monash University 138

6.2 Jun 13, 2022: Hephai appoints Armelle Roussac as head of sales 138

6.3 Jun 09, 2022: Inhalation Sciences and RISE collaborate successfully on first proposal for global project on antibiotic resistance 139

6.4 Jun 08, 2022: Baxter to Host Second-Quarter 2022 Financial Results Conference Call for Investors 139

6.5 May 25, 2022: Baxter Highlights Business Strategies and Innovation at 2022 Investor Conference 139

6.6 May 12, 2022: AstraZeneca joins Accumulus Synergy as a sponsor to accelerate the delivery of medicines to patients 140

6.7 May 11, 2022: Bellerophon Provides Clinical Program Update and Reports First Quarter 2022 Financial Results 140

6.8 May 10, 2022: Baxter to Host 2022 Investor Conference 142

6.9 May 09, 2022: Impel Pharmaceuticals to Report First Quarter 2022 Financial Results on Monday, May 16, 2022 142

6.10 Apr 28, 2022: Catalent expands nasal drug development and manufacturing capabilities at Morrisville, North Carolina, Facility 143

6.11 Apr 26, 2022: Harvard Bioscience introduces SmartStudy: First of kind, next generation inhalation system capability improves precision and drives growth 143

6.12 Apr 01, 2022: Inhalation Sciences signs IRS contract worth 491,000 SEK with returning nanotechnology client 144

6.13 Mar 31, 2022: Bellerophon Provides Clinical Program Update and Reports Full-Year 2021 Financial Results 144

6.14 Mar 24, 2022: Impel NeuroPharma Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update 146

6.15 Mar 23, 2022: AstraZeneca Notice of AGM 147

6.16 Mar 18, 2022: Catalent to Present at the KeyBanc Life Sciences & MedTech Investor Forum 148

6.17 Feb 22, 2022: Honeywell teams with Astrazeneca to develop next-generation respiratory inhalers that use near-zero global warming potential propellant 149

6.18 Feb 10, 2022: Baxter to Present at Citi’s 2022 Virtual Healthcare Conference 150

6.19 Feb 10, 2022: AstraZeneca announces Full year and Q4 2021 results 150

6.20 Jan 06, 2022: Baxter to Host Fourth-Quarter 2021 Financial Results Conference Call for Investors 152

6.21 Jan 05, 2022: Catalent Announces Plan for Alessandro Maselli to Become New CEO Effective July 1, 2022 153

6.22 Nov 24, 2021: Inhalation Sciences Sweden AB (publ) releases Q3 Report 2021 153

6.23 Nov 15, 2021: Bellerophon Provides Clinical Program Update and Reports Third Quarter 2021 Financial Results 154

6.24 Nov 15, 2021: Impel NeuroPharma Announces Third Quarter 2021 Financial Results and Provides Corporate Update 155

6.25 Nov 11, 2021: Baxter announces $100 million investment in BioPharma solutions Halle/Westfalen, Germany Sterile fill/finish manufacturing facility 157

6.26 Nov 03, 2021: EyePoint Pharmaceuticals Reports Third Quarter 2021 Financial Results and Highlights Recent Corporate Developments 157

6.27 Nov 02, 2021: Baxter to Present at Evercore ISI 4th Annual HealthCONx Conference 159

6.28 Oct 13, 2021: Baxter to Present at Credit Suisse 30th Annual Virtual Healthcare Conference 159

6.29 Sep 27, 2021: AstraZeneca COVID-19 and RSV presentations at IDWeek 2021 will showcase scientific progress in infectious diseases 27 September 2021 159

6.30 Sep 27, 2021: Baxter to Host Third-Quarter 2021 Financial Results Conference Call for Investors 160

6.31 Sep 21, 2021: AstraZeneca to invest $360m in advanced manufacturing facility in Ireland 160

6.32 Aug 16, 2021: Impel NeuroPharma Announces Second Quarter 2021 Financial Results and Provides Corporate Update 161

6.33 Aug 03, 2021: Impel NeuroPharma to Present at the 2021 Wedbush Pacgrow Virtual Healthcare Conference 162

6.34 Jul 29, 2021: AstraZeneca announces H1 2021 results 162

6.35 Jul 29, 2021: Baxter Reports Second-Quarter 2021 Results 165

6.36 Jul 29, 2021: Baxter to Present at UBS Genomics

2.0 and MedTech Innovations Summit 168

6.37 Jul 28, 2021: EyePoint Pharmaceuticals to Report Second Quarter 2021 Financial Results on August 4, 2021 168

6.38 Jul 07, 2021: Windtree to Present at the Ladenburg Thalmann 2021 Healthcare Conference (Virtual) 168

6.39 Jul 07, 2021: Virpax Pharmaceuticals provides progress update on product candidates 169

7 Appendix 170

7.1 Methodology 170

7.2 About GlobalData 172

7.3 Contact Us 173

7.4 Disclaimer 173

List of Tables

Inhalable Drug Delivery – Pipeline Products by Stage of Development 15

Inhalable Drug Delivery – Pipeline Products by Segment 16

Inhalable Drug Delivery – Pipeline Products by Territory 17

Inhalable Drug Delivery – Pipeline Products by Regulatory Path 19

Inhalable Drug Delivery – Pipeline Products by Estimated Approval Date 20

Inhalable Drug Delivery – Ongoing Clinical Trials 21

Inhalable Drug Delivery Companies – Pipeline Products by Stage of Development 22

Inhalable Drug Delivery – Pipeline Products by Stage of Development 25

Acerus Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 28

No-Touch Applicator Device – Product Status 28

No-Touch Applicator Device – Product Description 28

Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 29

Drug Delivery Device – Neonatal Respiratory Distress Syndrome (RDS) – Product Status 29

Drug Delivery Device – Neonatal Respiratory Distress Syndrome (RDS) – Product Description 29

Actervis GmbH Pipeline Products & Ongoing Clinical Trials Overview 30

Inhaluxe – Product Status 30

Inhaluxe – Product Description 30

Aerami Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 31

FOX Mesh Nebulizer – Pulmonary Arterial Hypertension – Product Status 31

FOX Mesh Nebulizer – Pulmonary Arterial Hypertension – Product Description 31

Aerophase Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Aerosol-Delivery System – Lung Cancer – Product Status 32

Aerosol-Delivery System – Lung Cancer – Product Description 32

Alexza Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Staccato Fentanyl Inhalation System – Product Status 33

Staccato Fentanyl Inhalation System – Product Description 33

Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 34

ProMaxx Microsphere – Product Status 34

ProMaxx Microsphere – Product Description 34

Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 35

INOpulse – Product Status 35

INOpulse – Product Description 35

Bellerophon Therapeutics Inc – Ongoing Clinical Trials Overview 36

INOpulse – A Randomized, Double-Blind, Placebo-Controlled Dose Escalation and Verification Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects at Risk of Pulmonary Hypertension Associated with Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2) – REBUILD 37

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 37

INOpulse – Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension 37

INOpulse – INOvation-2 Clinical Study of INOpulse Device 38

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) 38

INOpulse – Pivotal Phase 3 Study Evaluate the INOpulse for the Treatment of Pulmonary Hypertension Associated with Pulmonary Fibrosis 38

Breath Therapeutics Holding BV Pipeline Products & Ongoing Clinical Trials Overview 39

Lung-Targeted BOS Device – Product Status 39

Lung-Targeted BOS Device – Product Description 39

Breath Therapeutics Holding BV – Ongoing Clinical Trials Overview 40

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 41

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 41

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 41

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 42

California Northstate University College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 43

Drug Delivery System – PAH – Product Status 43

Drug Delivery System – PAH – Product Description 43

Canigma A.L LTD Pipeline Products & Ongoing Clinical Trials Overview 44

Vaporiser Device – Product Status 44

Vaporiser Device – Product Description 44

Cipla Ltd Pipeline Products & Ongoing Clinical Trials Overview 45

Complex Inhaler – Product Status 45

Complex Inhaler – Product Description 45

Smart Inhaler – Product Status 46

Smart Inhaler – Product Description 46

Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 47

Hava – Product Status 47

Hava – Product Description 47

Edixomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

NOx System – VAP – Product Status 48

NOx System – VAP – Product Description 48

Engage Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 49

Staccato Alprazolam – Product Status 49

Staccato Alprazolam – Product Description 49

iDTx Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50

GoPilot – Product Status 50

GoPilot – Product Description 50

Impel Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 51

INP105 – Product Status 51

INP105 – Product Description 51

POD Device – Product Status 52

POD Device – Product Description 52

Impel Pharmaceuticals Inc – Ongoing Clinical Trials Overview 53

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 with Autism Spectrum Disorder 54

Inhalation Sciences Sweden AB Pipeline Products & Ongoing Clinical Trials Overview 55

PreciseInhale System – Product Status 55

PreciseInhale System – Product Description 56

Inhalation Sciences Sweden AB – Ongoing Clinical Trials Overview 57

PreciseInhale System – A Clinical Validation Study of PreciseInhale System in Healthy Volunteers 58

Invero Pharma LLC Pipeline Products & Ongoing Clinical Trials Overview 59

XENEX – Product Status 59

XENEX – Product Description 59

Invero Pharma LLC – Ongoing Clinical Trials Overview 60

XENEX – Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome: XePOHCAS 61

Jupiter Research LLC Pipeline Products & Ongoing Clinical Trials Overview 62

Liquid9 – Product Status 62

Liquid9 – Product Description 62

Kanabo Research Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

Next Generation Smart VapePod MD Vaporizer – Product Status 63

Next Generation Smart VapePod MD Vaporizer – Product Description 63

VapePod – Product Status 64

VapePod – Product Description 64

Kanabo Research Ltd – Ongoing Clinical Trials Overview 65

VapePod – Study to Evaluate the Bioavailability and Efficacy for Kanabo’s Cannabis Inhalation Formulas in Conjunction with VapePod 66

Lupin Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 67

Soft-Mist Inhalation Device – Product Status 67

Soft-Mist Inhalation Device – Product Description 67

Mallinckrodt Plc Pipeline Products & Ongoing Clinical Trials Overview 68

Next Generation Inomax Evolve – Product Status 68

Next Generation Inomax Evolve – Product Description 68

Medical Developments International Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

Penthrox Inhaler – Product Status 70

Penthrox Inhaler – Product Description 71

Penthrox Inhaler – Paediatric – Product Status 71

Penthrox Inhaler – Paediatric – Product Description 71

Medical Developments International Ltd – Ongoing Clinical Trials Overview 72

Penthrox Inhaler – An Open-Label Study to Assess the Efficacy and Safety of Low Dose Methoxyflurane (Penthrox) for Pain Control During Outpatient Aesthetic Surgeries and Facial Filler Injections 73

Penthrox Inhaler – Methoxyflurane at Moderate High Altitudes for Pain Management: A Randomized, Double-blind, Cross-over Study 73

Penthrox Inhaler – Prospective, Multicenter Trial of Methoxyflurane for Acute Trauma-related Pain in Helicopter Emergency Medical Systems and Hostile Environments: METEORA 73

Penthrox Inhaler – Reduction of Anterior Shoulder Dislocation Facilitated by Inhaled Low Dose Methoxyflurane – A Pilot Study 74

Medspray BV Pipeline Products & Ongoing Clinical Trials Overview 75

Device 0075 – Product Status 75

Device 0075 – Product Description 75

Product 0070 – Product Status 76

Product 0070 – Product Description 76

Product 0077 – Product Status 76

Product 0077 – Product Description 77

Monash University Pipeline Products & Ongoing Clinical Trials Overview 78

Nebuliser – Product Status 78

Nebuliser – Product Description 78

Nemera La Verpilliere Pipeline Products & Ongoing Clinical Trials Overview 79

CUPIDO – Product Status 79

CUPIDO – Product Description 79

Next Safety, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80

Pulmonary Drug Delivery Device – Product Status 80

Pulmonary Drug Delivery Device – Product Description 80

Nobilis Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 81

Zephyrus – Product Status 81

Zephyrus – Product Description 81

Nobilis Therapeutics Inc – Ongoing Clinical Trials Overview 82

Zephyrus – A Double-blind, Randomized, Placebo-controlled Trial of Xenon Inhalation for Treatment of Patients with Panic Disorder 83

Zephyrus – A Double-blind, Randomized, Placebo-controlled Trial of Xenon Inhalation for Treatment of Patients with Posttraumatic Stress Disorder 83

OncoSec Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 84

NeoPulse – Skin Cancer – Product Status 84

NeoPulse – Skin Cancer – Product Description 84

Pharmosa Biopharm Inc Pipeline Products & Ongoing Clinical Trials Overview 85

L606 Inhalation System – Product Status 85

L606 Inhalation System – Product Description 85

L608 Inhalation System – Product Status 86

L608 Inhalation System – Product Description 86

Pharmosa Biopharm Inc – Ongoing Clinical Trials Overview 87

L606 Inhalation System – A Phase 3, 2-Part, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Liposomal Treprostinil Inhalation Suspension (L606) in Subjects with Pulmonary Arterial Hypertension Previously Stabilized on Inhaled Treprostinil Products 88

Rhinomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

Pronto Anxiety – Product Status 89

Pronto Anxiety – Product Description 89

Pronto Migraine – Product Status 90

Pronto Migraine – Product Description 90

Pronto Sleep Plus – Product Status 90

Pronto Sleep Plus – Product Description 91

Risproly Pipeline Products & Ongoing Clinical Trials Overview 92

Drug Delivery Device – Asthma – Product Status 92

Drug Delivery Device – Asthma – Product Description 92

Drug Delivery Device – CNS Disease – Product Status 93

Drug Delivery Device – CNS Disease – Product Description 93

Drug Delivery Device – COPD – Product Status 93

Drug Delivery Device – COPD – Product Description 94

Rutgers Cancer Institute of New Jersey Pipeline Products & Ongoing Clinical Trials Overview 95

Pulmonary Drug Delivery System – Product Status 95

Pulmonary Drug Delivery System – Product Description 95

Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 96

FreePath Drug Delivery System – Product Status 96

FreePath Drug Delivery System – Product Description 96

Seng Vital International GmbH Pipeline Products & Ongoing Clinical Trials Overview 97

Medihale 2 – Product Status 97

Medihale 2 – Product Description 97

Medihale Slim Line 1 – Product Status 98

Medihale Slim Line 1 – Product Description 98

Shenzhen Smoore Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

Inhalation Delivery Device – Product Status 99

Inhalation Delivery Device – Product Description 99

Sino Biopharmaceutical Ltd Pipeline Products & Ongoing Clinical Trials Overview 100

SFT-1001 – Product Status 100

SFT-1001 – Product Description 101

SFT-1002 – Product Status 101

SFT-1002 – Product Description 101

SFT-1003 – Product Status 102

SFT-1003 – Product Description 102

SFT-1004 – Product Status 102

SFT-1004 – Product Description 103

Technology Commercialization Partners LLC Pipeline Products & Ongoing Clinical Trials Overview 104

iNO Delivery System – Product Status 104

iNO Delivery System – Product Description 104

Tetra Bio-Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 105

CAUMZ-kit – Product Status 105

CAUMZ-kit – Product Description 105

Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

Digihaler – Product Status 106

Digihaler – Product Description 106

QVAR Digihaler – Product Status 107

QVAR Digihaler – Product Description 107

Texas Tech University Health Sciences Center Pipeline Products & Ongoing Clinical Trials Overview 108

Inhalable Nanoparticle System – Product Status 108

Inhalable Nanoparticle System – Product Description 109

Third Pole Inc Pipeline Products & Ongoing Clinical Trials Overview 110

eNOcare – Product Status 110

eNOcare – Product Description 110

eNOfit – Product Status 111

eNOfit – Product Description 111

Tiziana Life Sciences PLC Pipeline Products & Ongoing Clinical Trials Overview 112

Nasal Drug Delivery Device – Product Status 112

Nasal Drug Delivery Device – Product Description 112

Torrent Pharmaceuticals Ltd Pipeline Products & Ongoing Clinical Trials Overview 113

Mecobalamine Nasal Spray – Product Status 113

Mecobalamine Nasal Spray – Product Description 113

University Hospital Southampton NHS Foundation Trust Pipeline Products & Ongoing Clinical Trials Overview 114

Covsurf Drug Delivery System – Product Status 114

Covsurf Drug Delivery System – Product Description 114

University Hospital Southampton NHS Foundation Trust – Ongoing Clinical Trials Overview 115

Covsurf Drug Delivery System – A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19 116

University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 117

Pedinap – Product Status 117

Pedinap – Product Description 117

Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 118

FOX Vibrating Mesh Nebulizer – Product Status 118

FOX Vibrating Mesh Nebulizer – Product Description 118

VR475 Combination Device – Product Status 119

VR475 Combination Device – Product Description 119

VR647 – Product Status 119

VR647 – Product Description 120

Vectura Group Plc – Ongoing Clinical Trials Overview 121

VR647 – A Phase I Clinical Study of VR-647 122

VR647 – A Phase I Clinical Study of VR-647 in Adult Asthma Subjects 122

VR647 – Phase II Pharmacokinetic Study of VR-647 in Children 122

VR647 – Phase III Study of VR-647 122

Veoli Ltd Pipeline Products & Ongoing Clinical Trials Overview 123

Cannabis Inhaler Device – Product Status 123

Cannabis Inhaler Device – Product Description 123

Vero Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 124

GeNOsyl Acute DS – Product Status 124

GeNOsyl Acute DS – Product Description 124

GeNOSYL Chronic DS – Product Status 125

GeNOSYL Chronic DS – Product Description 125

NITROSYL System – Product Status 125

NITROSYL System – Product Description 126

Via Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 127

Inhaled Delivery System – Product Status 127

Inhaled Delivery System – Product Description 127

Virpax Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 128

NES100 – Product Status 128

NES100 – Product Description 128

VistaGen Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 129

PH94B Neuroactive Nasal Spray – Product Status 129

PH94B Neuroactive Nasal Spray – Product Description 130

VistaGen Therapeutics Inc – Ongoing Clinical Trials Overview 131

PH94B Neuroactive Nasal Spray – A Phase IIa Double-blind, Placebo-controlled, Parallel Study of PH94B Nasal Spray in the Treatment of Adjustment Disorder with Anxiety 132

PH94B Neuroactive Nasal Spray – A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects with Social Anxiety Disorder 132

VitalMIST Pipeline Products & Ongoing Clinical Trials Overview 133

VitalMIST – Product Status 133

VitalMIST – Product Description 133

Wellfully Ltd Pipeline Products & Ongoing Clinical Trials Overview 134

Nebulizer – Product Status 134

Nebulizer – Product Description 134

Windtree Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 135

Aerosol Drug Delivery Device – Acute Lung Injury – Product Status 135

Aerosol Drug Delivery Device – Acute Lung Injury – Product Description 135

AEROSURF – Product Status 136

AEROSURF – Product Description 136

Capillary Aerosol Generator (CAG) – Product Status 137

Capillary Aerosol Generator (CAG) – Product Description 137

Glossary 172

List of Figures

Inhalable Drug Delivery – Pipeline Products by Stage of Development 15

Inhalable Drug Delivery – Pipeline Products by Segment 16

Inhalable Drug Delivery – Pipeline Products by Territory 17

Inhalable Drug Delivery – Pipeline Products by Regulatory Path 19

Inhalable Drug Delivery – Pipeline Products by Estimated Approval Date 20

Inhalable Drug Delivery – Ongoing Clinical Trials 21

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