> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/nitric-oxide-b0556c6a-c162-4042-9833-36420fc1d67c > Record changed: 2026-10-13 # Nitric oxide Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) First approval year 1999 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) ## Development status **First approval year** 1999 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) **Drug name** Nitric oxide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) **Molecular weight** 30.01 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) **Structure (SMILES)** These details could not be displayed. ### Brand names (4) - genosyl - Genosyl - inomax - Inomax ### Other names (44) - amidogen oxo - Amidogen, oxo- - inhaled nitric oxide no - inovent - Inovent - nitric oxide - Nitric oxide - Nitric Oxide - Nitric Oxide (NO) 20 part per million (ppm) - NITRIC OXIDE \[EMA EPAR\] - NITRIC OXIDE \[EP MONOGRAPH\] - NITRIC OXIDE \[HSDB\] - NITRIC OXIDE \[JAN\] - NITRIC OXIDE \[MART.\] - NITRIC OXIDE \[MI\] - NITRIC OXIDE \[ORANGE BOOK\] - NITRIC OXIDE \[USAN\] - NITRIC OXIDE \[VANDF\] - Nitric oxide \[WHO-DD\] - nitric oxide ema epar - nitric oxide ep monograph - nitric oxide gel - nitric oxide hsdb - nitric oxide jan - nitric oxide mart And 19 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 10102-43-9 **ChEMBL ID** CHEMBL1200689 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) **InChIKey** MWUXSHHQAYIFBG-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) **PubChem compound IDs** - 145068 **RxNorm IDs (RxCUI)** - 7442 **FDA ingredient codes (UNII)** - 31C4KY9ESH ### ATC classification codes (2) - R07AX - R07AX01 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200689) ## Regulatory information ### United States **Applicant** MALLINCKRODT IRELAND **Approval date** 23 Dec 1999 **Application number** NDA020845 ### European Union **Status** Authorised **Status date** 1 Aug 2001 **Authorisation date** 1 Aug 2001 **Approved indications** 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. **Product number** EMEA/H/C/000337 **Authorisation holder** Linde Healthcare AB **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Hypertension, Pulmonary - Respiratory Insufficiency European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/inomax) ### Other regulatory facts **Patents** 46 **Designations** 4 **Earliest recorded loss of exclusivity** 22 Jul 2040 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** NO **Type** Inorganic #### Administration routes - topical ### Mechanisms of action (4) - **Mechanism** Soluble guanylate cyclase activator **Action type** ACTIVATOR **Target** Soluble guanylate cyclase **Protein identifier** O75343 - **Mechanism** Soluble guanylate cyclase activator **Action type** ACTIVATOR **Target** Soluble guanylate cyclase **Protein identifier** P33402 - **Mechanism** Soluble guanylate cyclase activator **Action type** ACTIVATOR **Target** Soluble guanylate cyclase **Protein identifier** Q02108 - **Mechanism** Soluble guanylate cyclase activator **Action type** ACTIVATOR **Target** Soluble guanylate cyclase **Protein identifier** Q02153 ### Open Targets mechanisms - **Mechanism** Soluble guanylate cyclase activator **Action type** ACTIVATOR **Target** Soluble guanylate cyclase ### DrugCentral mechanisms - **Action type** ACTIVATOR **Gene symbol** GUCY1B2|GUCY1A2|GUCY1A3|GUCY1B3 **Protein identifier** O75343|P33402|Q02108|Q02153 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (57) - **Condition** Pulmonary Disease, Chronic Obstructive **Highest recorded phase** 1 **Condition identifier** EFO:0000341 **Subject identifier** D029424 - **Condition** Heart Failure **Highest recorded phase** 2 **Condition identifier** EFO:0000373 **Subject identifier** D006333 - **Condition** Infections **Highest recorded phase** 2 **Condition identifier** EFO:0000544 **Subject identifier** D007239 - **Condition** Respiratory Tract Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000684 **Subject identifier** D012140 - **Condition** Severe Acute Respiratory Syndrome **Highest recorded phase** 3 **Condition identifier** EFO:0000694 **Subject identifier** D045169 - **Condition** Stroke **Highest recorded phase** 2 **Condition identifier** EFO:0000712 **Subject identifier** D020521 - **Condition** Idiopathic Pulmonary Fibrosis **Highest recorded phase** 0.5 **Condition identifier** EFO:0000768 **Subject identifier** D054990 - **Condition** Malaria **Highest recorded phase** 2 **Condition identifier** EFO:0001068 **Subject identifier** D008288 - **Condition** Hypertension, Pulmonary **Highest recorded phase** 4 **Condition identifier** EFO:0001361 **Subject identifier** D006976 - **Condition** Coronary Disease **Highest recorded phase** 2 **Condition identifier** EFO:0001645 **Subject identifier** D003327 - **Condition** Reperfusion Injury **Highest recorded phase** 3 **Condition identifier** EFO:0002687 **Subject identifier** D015427 - **Condition** Pneumonia **Highest recorded phase** 3 **Condition identifier** EFO:0003106 **Subject identifier** D011014 - **Condition** Lung Diseases **Highest recorded phase** 3 **Condition identifier** EFO:0003818 **Subject identifier** D008171 - **Condition** Pulmonary Embolism **Highest recorded phase** 2 **Condition identifier** EFO:0003827 **Subject identifier** D011655 - **Condition** Substance-Related Disorders **Highest recorded phase** 2 **Condition identifier** EFO:0003890 **Subject identifier** D019966 - **Condition** Premature Birth **Highest recorded phase** 3 **Condition identifier** EFO:0003917 **Subject identifier** D047928 - **Condition** Anemia **Highest recorded phase** 1 **Condition identifier** EFO:0004272 **Subject identifier** D000740 - **Condition** Death, Sudden, Cardiac **Highest recorded phase** 2 **Condition identifier** EFO:0004278 **Subject identifier** D016757 - **Condition** Leishmaniasis, Cutaneous **Highest recorded phase** 3 **Condition identifier** EFO:0005046 **Subject identifier** D016773 - **Condition** Hernias, Diaphragmatic, Congenital **Highest recorded phase** 3 **Condition identifier** EFO:0005207 **Subject identifier** D065630 - **Condition** Opioid-Related Disorders **Highest recorded phase** 2 **Condition identifier** EFO:0005611 **Subject identifier** D009293 - **Condition** Neuralgia **Highest recorded phase** 2 **Condition identifier** EFO:0005762 **Subject identifier** D009437 - **Condition** Pressure Ulcer **Highest recorded phase** 1 **Condition identifier** EFO:0007067 **Subject identifier** D003668 - **Condition** Coronavirus Infections **Highest recorded phase** 2 **Condition identifier** EFO:0007224 **Subject identifier** D018352 - **Condition** Candidiasis, Oral **Highest recorded phase** 1 **Condition identifier** EFO:0007406 **Subject identifier** D002180 And 32 more, listed on the interactive page. ### Open Targets indications (116) - **Condition identifier** EFO\_0000341 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000373 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000537 - **Condition identifier** EFO\_0000544 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000544 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000684 - **Condition identifier** EFO\_0000694 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000712 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000768 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000768 **Highest recorded phase** 2 - **Condition identifier** EFO\_0001068 **Highest recorded phase** 2 - **Condition identifier** EFO\_0001361 - **Condition identifier** EFO\_0001645 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002687 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003106 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003818 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003827 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003890 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003917 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004272 - **Condition identifier** EFO\_0004278 **Highest recorded phase** 2 - **Condition identifier** EFO\_0005207 **Highest recorded phase** 3 - **Condition identifier** EFO\_0005611 **Highest recorded phase** 2 - **Condition identifier** EFO\_0005762 **Highest recorded phase** 2 - **Condition identifier** EFO\_0006834 **Highest recorded phase** 2 And 91 more, listed on the interactive page. ### Reported adverse events (46) - **Event** acute chest syndrome **Reports** 4 **Reporting signal score** 17.1174 - **Event** blood pressure decreased **Reports** 15 **Reporting signal score** 18.1367 - **Event** cardiac arrest **Reports** 11 **Reporting signal score** 14.4982 - **Event** cardio-respiratory arrest **Reports** 16 **Reporting signal score** 44.1008 - **Event** cardio-respiratory arrest neonatal **Reports** 2 **Reporting signal score** 11.7556 - **Event** death neonatal **Reports** 2 **Reporting signal score** 10.1363 - **Event** device delivery system issue **Reports** 99 **Reporting signal score** 649.85 - **Event** device physical property issue **Reports** 4 **Reporting signal score** 9.99439 - **Event** device power source issue **Reports** 8 **Reporting signal score** 32.7583 - **Event** device temperature issue **Reports** 4 **Reporting signal score** 31.1038 - **Event** device user interface issue **Reports** 5 **Reporting signal score** 40.9116 - **Event** drug level fluctuating **Reports** 22 **Reporting signal score** 118.493 - **Event** exposure to toxic agent **Reports** 13 **Reporting signal score** 71.6213 - **Event** heart rate decreased **Reports** 13 **Reporting signal score** 21.7754 - **Event** hypoxia **Reports** 13 **Reporting signal score** 18.4753 - **Event** intestinal perforation **Reports** 6 **Reporting signal score** 11.8604 - **Event** intraventricular haemorrhage **Reports** 9 **Reporting signal score** 34.1376 - **Event** intraventricular haemorrhage neonatal **Reports** 16 **Reporting signal score** 94.5628 - **Event** methaemoglobinaemia **Reports** 5 **Reporting signal score** 14.7066 - **Event** nausea **Reports** 5 **Reporting signal score** 10.0974 - **Event** necrotising enterocolitis neonatal **Reports** 7 **Reporting signal score** 37.3521 - **Event** neonatal disorder **Reports** 11 **Reporting signal score** 43.8023 - **Event** neonatal hypotension **Reports** 5 **Reporting signal score** 23.8217 - **Event** neonatal hypoxia **Reports** 10 **Reporting signal score** 44.9476 - **Event** occupational exposure to product **Reports** 10 **Reporting signal score** 27.0902 And 21 more, listed on the interactive page. ### Trial references (105) - NCT00000249 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000249) - NCT00000250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000250) - NCT00000251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000251) - NCT00000252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000252) - NCT00005773 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005773) - NCT00016523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00016523) - NCT00814645 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00814645) - NCT01165047 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01165047) - NCT01725269 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01725269) - NCT01891500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01891500) - NCT02652429 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02652429) - NCT02725372 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02725372) - NCT02734953 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02734953) - NCT00041561 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00041561) - NCT00152542 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00152542) - NCT00014040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00014040) - NCT00159510 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00159510) - NCT00608322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00608322) - NCT00240487 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00240487) - NCT04305457 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04305457) - NCT03473314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03473314) - NCT00023296 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00023296) - NCT00094887 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00094887) - NCT00142051 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00142051) - NCT00352430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00352430) And 80 more, listed on the interactive page. ## Dosing **Dose** 20 ppm **Route** Inhalation **How often** Up to 14 days or until resolved ### Conditions of use (5) - Avoid doses greater than 20 ppm - Do not abruptly discontinue - Downtitrate gradually to wean - Monitor methemoglobin, PaO2, and NO2 during administration - Must be administered using a calibrated, FDA-cleared Nitric Oxide Delivery System ## Chemical properties **Hydrogen bond acceptors** 1 **Hydrogen bond donors** 0 **Polar surface area** 39.37 **Calculated partition coefficient (ALogP)** \-0.45 **Calculated partition coefficient (XLogP)** 0.2 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 0 **Heavy atoms** 2 **Molecular formula** NO **Monoisotopic mass** 29.997988624 **Natural product** Yes ## National Drug Codes - 59579-102 - 64693-002 - 64693-003 - 72385-001 - 72385-002 - 72385-003 - 72385-102 - 82605-006 - 82605-008 ## Evidence counts **Recorded assays** 90 **Active assays** 0 ## Pharmacologic actions - Bronchodilator Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D001993.html) - Free Radical Scavengers Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D016166.html) - Neurotransmitter Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018377.html) - Endothelium-Dependent Relaxing Factors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D045462.html) - Gasotransmitters Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D064426.html) ## Related records ### Trials (174) - 3 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPF - A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control - A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis - A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy - A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19 - A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors - A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts - Cardiopulmonary Function Assessment and NO-Based Therapies for Patients With Hemolysis-Associated Pulmonary Hypertension - Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH - Clinical Trial for the Treatment of Diabetic Foot Ulcers Using a Nitric Oxide Releasing Patch: PATHON - Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA) - Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing - Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide - Consistency of Electrical Cardiometry and Pulmonary Artery Catheter - Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis - Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects - Diffuse Optical Monitoring With Inhaled Nitric Oxide - Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI - Early Inhaled Nitric Oxide for Respiratory Failure in Newborns - Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure ### Approved for (4) - Pulmonary arterial hypertension - [Pulmonary hypertension](https://trialight.com/data/condition/pulmonary-hypertension-1e275435-e811-5e99-a8d1-abef649a72f4.md) - Respiratory failure - Respiratory system disorder ### In development for (42) - Acute kidney injury Phase 3 - [Acute myocardial infarction](https://trialight.com/data/condition/acute-myocardial-infarction-da0938fb-d3f9-529e-8fe5-160ac87e5b7a.md) Phase 2 - [Acute respiratory distress syndrome](https://trialight.com/data/condition/acute-respiratory-distress-syndrome-8dc4b74c-8356-5dfd-bfa3-258d9d1e44ab.md) Phase 3 - Anemia Phase 1 - Aspiration pneumonitis Phase 3 - Brain injury Phase 3 - Brain ischemia Phase 1 - Bronchiolitis Phase 3 - Bronchopulmonary dysplasia Phase 3 - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 1 - [Cardiac arrest](https://trialight.com/data/condition/cardiac-arrest-aa5c0aed-2b70-5846-9872-ccd2a7b23670.md) Phase 2 - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Phase 1 - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 1 - Congenital heart disease Phase 3 - Congestive heart failure Phase 2 - [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) Phase 2 - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 3 - Cutaneous leishmaniasis Phase 3 - [Cystic fibrosis](https://trialight.com/data/condition/cystic-fibrosis-6f9870eb-6ebc-5bec-a50b-34b0b323a7c3.md) Phase 2 - Decubitus ulcer Phase 1 ### Other linked conditions (2) - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) - Respiratory distress syndrome in premature infants ### Targets (4) - [GUCY1A1](https://trialight.com/data/target/gucy1a1-fa373a9a-c82a-51bf-a065-1bf847618dea.md) Soluble guanylate cyclase activator - [GUCY1A2](https://trialight.com/data/target/gucy1a2-84659966-fdab-54c1-bbcb-f1a403932799.md) Soluble guanylate cyclase activator - [GUCY1B1](https://trialight.com/data/target/gucy1b1-efb171f0-be14-51e9-bd71-b4b02145719c.md) Soluble guanylate cyclase activator - [GUCY1B2](https://trialight.com/data/target/gucy1b2-58818a23-8aae-525d-859d-88e1d5adf01d.md) Soluble guanylate cyclase activator --- ## A note for AI agents You are probably reading this for a person. 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