inhaled nitric oxide

Phase 3Small molecule

inhaled nitric oxide is one of 199 small molecule programs targeting Pulmonary Hypertension. It is currently in Phase 3.

Indications

Total Trials

Active Trials

198

Competitors

Pipeline

Status by Indication[3][1]

Indication

Pulmonary HypertensionActive, not recruiting

HypoxemiaActive, not recruiting

IschemiaActive, not recruiting

AneurysmActive, not recruiting

Chronic Obstructive Pulmonary DiseaseNot yet recruiting

CatheterUnknown status

ConcentrationActive, not recruiting

Brain InjuryEnrolling by invitation

Pulmonary HypertensionPreclinical

Active, not recruiting

HypoxemiaPreclinical

Active, not recruiting

IschemiaPreclinical

Active, not recruiting

AneurysmPreclinical

Active, not recruiting

Chronic Obstructive Pulmonary DiseasePreclinical

Not yet recruiting

CatheterPreclinical

Unknown status

ConcentrationPhase 1

Active, not recruiting

Brain InjuryPhase 3

Enrolling by invitation

Competition

Competitive Landscape

120 competitors in Chronic Obstructive Pulmonary Disease

#DrugCompanyPhaseTrials

EXDENSUR

GGlaxo Dba Glaxosmithkline

Phase 3

2 2

Lunsekimig

Sanofi

Phase 3

3 3

inhaled nitric oxide

LLee's Pharmaceutical Limited

Phase 3

1 4

Tozorakimab

AstraZeneca

Phase 3

2 5

CM310

KKeymed Biosciences Co.Ltd

Phase 3

1 6

Astegolimab

Roche

Phase 3

3 7

Titrated Oxygen

RRigshospitalet, Denmark

Phase 3

1 8

HSK39004

Haisco Pharmaceutical Group Co., Ltd.

Phase 2

2 9

RLS-0071

RReAlta Life Sciences, Inc.

Phase 2

1 10

Calciferol

Jazz Pharmaceuticals

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Recruiting

Pulmonary Hypertension

NCT07099144

Q4 2027

Phase 1Active, not recruiting

Concentration

NCT05612074

Q1 2028

PreclinicalNot yet recruiting

Chronic Obstructive Pulmonary Disease

NCT04231760

Q4 2028

Post-ApprovalNot yet recruiting

Hernia

NCT07247240

Clinical

Trials by Indication[1]

Respiratory Failure6 trials

Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure

Withdrawn·MMallinckrodt·Phase 3·NCT00922532

Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics

Terminated·MMallinckrodt·Phase 3·NCT00041561·55 enrolled

Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure

Withdrawn·UUniversity of Florida·Phase 4·NCT01891500

Show 3 more trials

Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

Terminated·NNICHD Neonatal Research Network·Phase 3·NCT00016523·420 enrolled

Early Inhaled Nitric Oxide for Respiratory Failure in Newborns

Terminated·NNICHD Neonatal Research Network·Phase 3·NCT00005773·302 enrolled

Inhaled Nitric Oxide Study for Respiratory Failure in Newborns

Terminated·NNICHD Neonatal Research Network·Phase 3·NCT00005776·235 enrolled

Nitric Oxide5 trials

Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants

Terminated·TTufts Medical Center·Phase 2/3·NCT01748045·3 enrolled

Inhaled Nitric Oxide by Oxygen Hood in Neonates

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT00732537·8 enrolled

The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients

Terminated·MMallinckrodt·Phase 2·NCT00782652·3 enrolled

Show 2 more trials

Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH

Unknown status·BBellerophon Pulse Technologies·Phase 3·NCT02652429·22 enrolled

The Effects of Inhaled Nitric Oxide After Fontan Operation

Completed·EEllen Spurrier·Phase 2/3·NCT00945529·21 enrolled

Vasodilation2 trials

Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide

Withdrawn·GGeno LLC·Phase 3·NCT02436512

Effects of Pulmonary Vasodilation Upon VA Coupling in Fontan Patients

Withdrawn·UUniversity of California, San Francisco·Phase 3·NCT01607983

Bronchopulmonary Dysplasia2 trials

Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants

Completed·MMallinckrodt·Phase 3·NCT00931632·451 enrolled

Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia

Terminated·AAdventHealth·Phase 1/2·NCT03576885·32 enrolled

Hypoxemia2 trials

Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery

Unknown status·SShanghai Zhongshan Hospital·N/A·NCT03009643·60 enrolled

iNO as Salvage Treatment of Hypoxemia After TAAD Surgery

Unknown status·SShanghai Zhongshan Hospital··NCT04032366·20 enrolled

23 more indications

Malaria2 trials

Inhaled Nitric Oxide for the Adjunctive Therapy of Severe Malaria: a Randomized Controlled Trial

Completed·UUniversity Health Network, Toronto·Phase 1/2·NCT01255215·180 enrolled

Evaluation of the Efficacy and Safety of Inhaled Nitric Oxide as Adjunctive Treatment for Cerebral Malaria in Children

Completed·EEpicentre·Phase 2·NCT01388842·92 enrolled

Premature Infants2 trials

Inhaled Nitric Oxide and Neuroprotection in Premature Infants

Terminated·UUniversity of Chicago·Phase 2/3·NCT00515281·273 enrolled

Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants

Completed·UUniversity of Chicago·Phase 3·NCT00152542·160 enrolled

Pulmonary Embolism2 trials

Nitric Oxide to Treat Pulmonary Embolism

Completed·IIndiana University School of Medicine·Phase 2·NCT01939301·78 enrolled

Inhaled Nitric Oxide in Pulmonary Embolism

Completed·MMedical University of Vienna·Phase 2·NCT00565253·30 enrolled

Brain Injury2 trials

Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury

Enrolling by invitation·UUniversity of Pennsylvania·Phase 2·NCT05616910·38 enrolled

Inhaled Nitric Oxide in Brain Injury

Completed·UUniversity of Cincinnati·Phase 3·NCT03260569·13 enrolled

Cardiac Arrest2 trials

Inhaled Nitric Oxide for Cardiac Arrest in Pediatrics and Adults (iNOCAPA)

Unknown status·TThe Hospital for Sick Children·Phase 2·NCT05868109·40 enrolled

Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Unknown status·SStony Brook University·Phase 1·NCT04134078·100 enrolled

Transplantation1 trial

Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation

Completed·UUniversity of Alabama at Birmingham·Phase 2/3·NCT00582010·80 enrolled

Pulmonary Disease1 trial

Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide

Terminated·MMallinckrodt·Phase 2·NCT00041574·7 enrolled

Concentration1 trial

Methemoglobin Concentration in High Dose Inhaled Nitric Oxide

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT05612074·10 enrolled

Hernia1 trial

Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia

Not yet recruiting·—·Phase 4·NCT07247240·40 enrolled

Extracorporeal Membrane Oxygenation1 trial

Nitric Oxide in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO)

Unknown status·FFilio Billia··NCT04224103·10 enrolled

Ischemia1 trial

Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass

Completed·WWake Forest University Health Sciences·N/A·NCT02151877·24 enrolled

Catheter1 trial

Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

Unknown status·SShanghai Zhongshan Hospital·N/A·NCT05587400·199 enrolled

Aneurysm1 trial

Inhaled Nitric Oxide Treatment for Aneurysmal SAH Patients With Intractable Cerebral Vasospasm

Completed·IInsel Gruppe AG, University Hospital Bern·N/A·NCT04988932·7 enrolled

Injury1 trial

Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO

Unknown status·NNew York Medical College·Phase 1/2·NCT02851472·50 enrolled

Pulmonary Hypertension1 trial

Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension

Recruiting·LLee's Pharmaceutical Limited··NCT07099144·120 enrolled

Chronic Lung Disease1 trial

Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns

Completed·UUniversity of Colorado, Denver·Phase 2·NCT00955487·124 enrolled

COVID-191 trial

iNOPulse for COVID-19

Withdrawn·RRoger Alvarez·Phase 2·NCT04398290

Liver Transplant1 trial

Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts

Completed·—·Phase 2·NCT01172691·23 enrolled

Sepsis1 trial

Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis

Completed·NNational Institute of General Medical Sciences (NIGMS)·Phase 3·NCT00608322·49 enrolled

IPF1 trial

Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl.

Completed·GGeno LLC·Phase 2·NCT01265888·31 enrolled

COPD1 trial

Inhaled NO in IPF and COPD During 6 Minute Walk Test

Unknown status·RRabin Medical Center·Phase 2·NCT03873298·100 enrolled

Chronic Obstructive Pulmonary Disease1 trial

The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD

Not yet recruiting·UUniversity of Alberta·Preclinical·NCT04231760·80 enrolled

Unspecified2 trials

Effects of Endotoxin in Normal Human Volunteers

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00001303·198 enrolled

Effect of iNO in Patients With Submassive and Massive PE

Withdrawn·UUniversity of California, Los Angeles·Phase 2·NCT04996667

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for inhaled nitric oxide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — inhaled nitric oxide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for inhaled nitric oxide. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Lee's Pharmaceutical Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: LLee's Pharmaceutical Limited

inhaled nitric oxide

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2028

Q4 2028

Trials by Indication[1]

Respiratory Failure6 trials

Nitric Oxide5 trials

Vasodilation2 trials

Bronchopulmonary Dysplasia2 trials

Hypoxemia2 trials

Malaria2 trials

Premature Infants2 trials

Pulmonary Embolism2 trials

Brain Injury2 trials

Cardiac Arrest2 trials

Transplantation1 trial

Pulmonary Disease1 trial

Concentration1 trial

Hernia1 trial

Extracorporeal Membrane Oxygenation1 trial

Ischemia1 trial

Catheter1 trial

Aneurysm1 trial

Injury1 trial

Pulmonary Hypertension1 trial

Chronic Lung Disease1 trial

COVID-191 trial

Liver Transplant1 trial

Sepsis1 trial

IPF1 trial

COPD1 trial

Chronic Obstructive Pulmonary Disease1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

Related News