Drug

Nitric Oxide

Approved · EMA

ClassSoluble guanylate cyclase activatorActively researchedLate-stage developmentRising momentum

Also known as EDRF, INOmax, Mononitrogen monoxide, Monoxyde d'azote+16 more

EDRF, INOmax, Mononitrogen monoxide, Monoxyde d'azote, Monóxido de nitrógeno, NO, NO - Nitric oxide, Nitric oxide gas, Nitrogen monooxide, Nitrogen monoxide, Nitrosyl, Noxivent, Oxyde azotique, Oxyde nitrique, Stickstoff(II)-oxid, Stickstoffmonoxid, Ulspira, endothelium-derived relaxing factor, óxido de nitrógeno(II), óxido nítrico.

RxNorm7442 ChEMBLCHEMBL1200689 ATCR07AX01UNII31C4KY9ESH

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

An Open-label, Randomised, Phase-I, Multi-Centre Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men With Newly Diagnosed Prostate Cancer (ASCERTAIN)

Clinical trial2026-06-15Completed · ClinicalTrials.gov

The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease.

Clinical trial2026-06-01Withdrawn · ClinicalTrials.gov

Effect of Inhaled Nitric Oxide on Major Adverse Events Requiring Intensive Life Support in Adults Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Phase III, Double-Blind, Multicenter, Randomized Controlled Trial (Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass, the NORISC Trial)

Clinical trial2026-05-29Results expected Q1 2028 · ClinicalTrials.gov

GOG-3068: A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Homologous Recombinant Deficient (HRD +) Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Heated Ovarian Treatment Trial)

Clinical trial2026-04-16Results expected Q3 2029 · ClinicalTrials.gov

Nitric Oxide Gas Inhalation Therapy for Mechanically Ventilated Patients With Severe Acute Respiratory Syndrome Caused by SARS-CoV2: a Randomized Clinical Trial.

Clinical trial2026-04-01Results posted · ClinicalTrials.gov

Prevention of Acute Kidney Injury by Nitric Oxide in Prolonged Cardiopulmonary Bypass. A Double Blind Controlled Randomized Trial in Cardiac Surgical Patients With Endothelial Dysfunction.

Clinical trial2026-03-10Results posted · ClinicalTrials.gov

Understanding chronic inflammation: couplings between cytokines, ROS, NO, Ca<sub>i</sub> <sup>2+</sup>, HIF-1α, Nrf2 and autophagy.

Research2025-04-08Frontiers in immunology

Neurological Manifestations Following Traumatic Brain Injury: Role of Behavioral, Neuroinflammation, Excitotoxicity, Nrf-2 and Nitric Oxide.

Research2025-01-01CNS & neurological disorders drug targets

Systemic and Cardiac Microvascular Dysfunction in Hypertension.

Research2024-12-11International journal of molecular sciences

The Unexpected Role of the Endothelial Nitric Oxide Synthase at the Neurovascular Unit: Beyond the Regulation of Cerebral Blood Flow.

Research2024-08-21International journal of molecular sciences

Approval: INOmax (EMA)

Regulatory2001-08-01EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Nitric Oxide

Aliases & brands

EDRFINOmaxMononitrogen monoxideMonoxyde d'azoteMonóxido de nitrógenoNONO - Nitric oxideNitric oxide gasNitrogen monooxideNitrogen monoxideNitrosylNoxiventOxyde azotiqueOxyde nitriqueStickstoff(II)-oxidStickstoffmonoxidUlspiraendothelium-derived relaxing factoróxido de nitrógeno(II)óxido nítrico

RxNorm CUI

7442

ChEMBL ID

CHEMBL1200689

ATC codes

R07AX01

UNII

31C4KY9ESH

Primary mechanism

Soluble guanylate cyclase activator

Regulatory jurisdictions

ema

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Guanylate cyclase soluble subunit beta-1

GUCY1B1 · Q02153

ACTIVATORSoluble guanylate cyclase activator

Guanylate cyclase soluble subunit beta-2

GUCY1B2 · O75343

ACTIVATORSoluble guanylate cyclase activator

Guanylate cyclase soluble subunit alpha-2

GUCY1A2 · P33402

ACTIVATORSoluble guanylate cyclase activator

Guanylate cyclase soluble subunit alpha-1

GUCY1A1 · Q02108

ACTIVATORSoluble guanylate cyclase activator

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2001-08-01

Latest approval

2001-08-01

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2001-08-01Approval

Approval: INOmax (EMA)

Indication: INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ?34 weeks gestation with hypoxic… Show full indication

INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ?34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

101 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

101

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 101

Early Phase 13Phase 17Phase 1 / 211Phase 238Phase 2 / 34Phase 318Phase 412Phase N / A8

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy of Nitric Oxide Administration for Reducing the Risk of Acute Kidney Injury in Patients With Acute Type A Aortic Dissection: a Randomized Controlled Trial

CompletedPH IVBeijing Anzhen Hospitaln=1062026

A Randomized, Open Label, Parallel Group, Study of the Impact of Aripiprazole (Abilify®) Once Monthly Versus Standard of Care Oral Antipsychotic Medications on Changes in Brain Structure and Metabolism

CompletedPH IVUniversity of Utahn=472020

Sleep and Breathing in Health and Disease (Part 2A - Chemical Stimuli, Sleep and Breathing in the General Population)

CompletedPH IVWayne State Universityn=142020

Optimized Chronic Care for Smokers: A Comparative Effectiveness Approach; Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit

CompletedPH IVUniversity of Wisconsin, Madisonn=5772019

Calcium Sulfate Spacer in Open Tibia Fractures With Sub-segmental Bone Loss to Decrease the Need for Secondary Surgery

TerminatedPH IVUniversity of Washingtonn=12018

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IAstraZenecan=1132026

Efficacy of Nitric Oxide Administration for Reducing the Risk of Acute Kidney Injury in Patients With Acute Type A Aortic Dissection: a Randomized Controlled Trial

CompletedPH IVBeijing Anzhen Hospitaln=1062026

Prevention of Acute Kidney Injury by Nitric Oxide in Prolonged Cardiopulmonary Bypass. A Double Blind Controlled Randomized Trial in Cardiac Surgical Patients With Endothelial Dysfunction.

CompletedPH IIIMassachusetts General Hospitaln=2502025

Phase 1 Single Centre, Open-labeled Clinical Trial to Evaluate the Safety and Tolerability of Topical Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis

CompletedPH ISanotize Research and Development corp.n=62024

Combined N-of-1 Trials to Assess Open-Label Placebo Treatment for Antidepressant Discontinuation Symptoms

CompletedN/AUniversitätsklinikum Hamburg-Eppendorfn=252024

Inhaled NO ReDuce postoperatIve pulmoNAry complicATions in patiEnts With Recent COVID-19 Infection

CompletedPH IIXijing Hospitaln=6602024

Research activity

28 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

19942025

Most influential

Nitric oxide and peroxynitrite in health and disease.

Physiological reviews · 2007 · 4,232 cites

Endothelial Cell Dysfunction and the Pathobiology of Atherosclerosis.

Circulation research · 2016 · 2,625 cites

Arginine metabolism: nitric oxide and beyond.

The Biochemical journal · 1998 · 1,902 cites

Autophagy, mitochondria and oxidative stress: cross-talk and redox signalling.

The Biochemical journal · 2012 · 1,075 cites

Cutting edge: heat shock protein 60 is a putative endogenous ligand of the toll-like receptor-4 complex.

Journal of immunology (Baltimore, Md. : 1950) · 2000 · 1,037 cites

The identification of markers of macrophage differentiation in PMA-stimulated THP-1 cells and monocyte-derived macrophages.

PloS one · 2010 · 896 cites

Related diseases

8 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Neoplasms3 Atherosclerosis2 Cardiovascular Diseases2 Chronic Disease2 Diabetes Mellitus2 Diabetes Mellitus, Type 22 Diabetic Angiopathies2 Inflammation2

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Vitamin D

Studied across 11 of the same disease areas as Nitric Oxide in the shared literature.

11 shared diseases1 shared paper

Hydrogen Peroxide

Studied across 4 of the same disease areas as Nitric Oxide in the shared literature.

4 shared diseases3 shared papers

Oxygen

Studied across 6 of the same disease areas as Nitric Oxide in the shared literature.

6 shared diseases1 shared paper

Amino Acids

Studied across 5 of the same disease areas as Nitric Oxide in the shared literature.

5 shared diseases1 shared paper

Sirolimus

Studied across 4 of the same disease areas as Nitric Oxide in the shared literature.

4 shared diseases1 shared paper

Niacin

Studied across 3 of the same disease areas as Nitric Oxide in the shared literature.

3 shared diseases1 shared paper

Adenine

Studied across the same disease area as Nitric Oxide in the shared literature.

1 shared disease1 shared paper

Arginine

Studied across the same disease area as Nitric Oxide in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.