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
