Nitric Oxide
Other / unclassified targets CFTR via activation
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | INOMAX | — | 2010-12-21 – 2015-10-09 | fda.gov ↗ |
| Approved | EU (EMA) | INOmax | — | 2001-08-01 | europa.eu ↗ |
| Approved | US (FDA) | INOMAX | — | 1999-12-23 | fda.gov ↗ |
Trials 134 · started per year
Also used as a comparator or background therapy in 28 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05052229 Comparator | Apr 2022 → Dec 2024 | idiopathic pulmonary fibrosis | Dr. Denis O'Donnell | Unknown | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT02267655 Comparator | May 2015 → Jun 2017 | chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, pulmonary hypertension | Bellerophon | Completed | No outcome recorded |
| Phase 1 | NCT00159510 Comparator | Apr 2004 → Sep 2014 | infectious disease with sepsis | Northern State Medical University | Terminated | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04601077 Comparator | Nov 2020 → Nov 2022 | COVID-19 | Nitric Oxide Innovations LLC | Terminated | No outcome recorded |
| Phase 1/2 | NCT03576885 Comparator | Jul 2019 → Oct 2023 | bronchopulmonary dysplasia, pulmonary hypertension | AdventHealth | Terminated | No outcome recorded |
| Phase 1/2 | NCT01351493 Comparator | Jul 2012 → Jul 2013 | decubitus ulcer | China Medical University Hospital | Unknown | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT04996667 Comparator | Jun 2026 → Dec 2027 | pulmonary embolism | University of California, Los Angeles | Withdrawn | No outcome recorded |
| Phase 2 | NCT05877313 Comparator | Aug 2023 → Feb 2024 | plantar wart | Sanotize Research and Development corp. | Completed | No outcome recorded |
| Phase 2 | NCT02217683 Comparator | Mar → Dec 2016 | hemolytic anemia, pulmonary hypertension | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT01939301 Comparator | Oct 2013 → Oct 2016 | pulmonary embolism | Indiana University | Completed | No outcome recorded |
| Phase 2 | NCT02295566 Comparator | May 2011 → Dec 2012 | cystic fibrosis | University Hospital Southampton NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT01398384 Comparator | Oct 2010 → May 2014 | acute myocardial infarction | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 2 | NCT01089439 Comparator | Jun 2010 → Nov 2013 | acute chest syndrome, sickle cell disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT00613808 Comparator | Feb → Nov 2008 | ulcer of lower limbs | Nitric BioTherapeutics, Inc | Terminated | No outcome recorded |
| Phase 2 | NCT00782652 Comparator | Mar 2006 → Feb 2007 | myocardial infarction | Mallinckrodt | Terminated | No outcome recorded |
| Phase 2 | NCT00570245 Comparator | Apr 2005 → Jun 2008 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 2 | NCT00060840 Comparator | Jul 2003 → Jun 2008 | congestive heart failure | Mallinckrodt | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05109611 Comparator | Nov 2021 → Jan 2024 | COVID-19 | Sanotize Research and Development corp. | Terminated | No outcome recorded |
| Phase 3 | NCT05599919 Comparator | Nov 2021 → Jan 2022 | COVID-19 | Sanotize Research and Development corp. | Completed | No outcome recorded |
| Phase 3 | NCT03260569 Comparator | Dec 2018 → Dec 2023 | traumatic brain injury | University of Cincinnati | Completed | No outcome recorded |
| Phase 3 | NCT03661385 Comparator | Jul 2018 → Mar 2022 | cardiogenic shock, transposition of the great arteries | Murdoch Childrens Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT00551642 Comparator | May 2005 → Mar 2008 | lung disorder | Mallinckrodt | Completed | No outcome recorded |
| Phase 3 | NCT00240487 Comparator | Sep 2000 → Sep 2008 | pediatric acute respiratory distress syndrome | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05213676 Comparator | Nov 2025 → Oct 2030 expected | congenital diaphragmatic hernia | The University of Texas Health Science Center, Houston | Recruiting | No outcome recorded |
| Phase 4 | NCT04231084 Comparator | Jan 2021 → Aug 2024 | pulmonary hypertension | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03081052 Comparator | May 2017 → Oct 2020 | — | Duke University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05587400 Background | Jul 2022 → Dec 2024 | pulmonary arterial hypertension | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| — | NCT04920695 Comparator | May 2021 → May 2023 | pulmonary embolism | Dr. Denis O'Donnell | Completed | No outcome recorded |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 174 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nitric oxide | “Inhaled nitric oxide (iNO) has been shown to result in benefits in moderate to vigorous physical activity (MVPA) in patients with fibrotic interstitial lung disease (f-ILD)...” PMID 39141673 ↗ Dec 2024149“Inhaled nitric oxide will be administered via the anesthesia machine, under the supervision of the attending Anesthesiologist, at a concentration of 20 parts per million (ppm)...” NCT07125443 ↗ “Inhaled nitric oxide (iNO) is commonly administered for selectively inhaled pulmonary vasodilation and prevention of oxidative injury after lung transplant (LT).” PMID 34787647 ↗ Jan 2022 “Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension” NCT05356052 ↗ “A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis” NCT05747508 ↗ “such as nitric oxide (NO), carbon monoxide (CO), and hydrogen sulfide (H₂S), are small gaseous signaling molecules” NCT06739538 ↗ “Subjects will be treated with nitric oxide by means of an INOpulse DS-C device using an INOpulse nasal cannula.” NCT01728220 ↗ “Traditional treatment plus inhaled nitric oxide therapy (20-40 ppm, continuous administration for 12-24 hours)” NCT07639931 ↗ “before and after exposure to inhaled nitric oxide in patients with pulmonary arterial hypertension (PAH)” NCT02220023 ↗ “supplemental Nitric Oxide (NO) gas delivered during cardiac surgery” NCT03946462 ↗ “Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo” NCT04421508 ↗ “Nitric Oxide Nasal Spray "Enovid"” NCT05012319 ↗ “Dietary Supplement: Nitric Oxide” NCT06213077 ↗ “inhaled nitric oxide (5 ppm)” PMID 16870914 ↗ Jul 2006 |
| Known as | Enovid | “Nitric Oxide Nasal Spray "Enovid"” NCT05012319 ↗ |
| Known as | gNO | “gases Nitric Oxide (gNO)” NCT04259684 ↗ |
| Known as | IK-3001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01959828 ↗ |
| Known as | Inhaled nitric oxide | “Inhaled nitric oxide is a controversial treatment for premature infants with severe respiratory failure.” PMID 16000352 ↗ Jul 2005 |
| Known as | inhaled nitric oxide, iNO, iNOMax | “inhaled nitric oxide, iNO, iNOMax” NCT03079102 ↗ |
| Known as | Inhaled NO | “Inhaled NO has regulatory approval in man by the Food and Drug Administration (FDA) and by the European Medicines Agency (EMA) for the treatment of several pulmonary pathologies.” NCT04988932 ↗1“Inhaled Nitric Oxide Intervention: Inhaled NO is a selective pulmonary vasodilator and has been shown to improve blood flow to well-ventilated lung areas” NCT04231760 ↗ |
| Known as | INO | “Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial...” NCT00005776 ↗38“Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO) and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery...” NCT01717209 ↗ “The goal of this clinical trial is to learn the formation and recovery rate of methemoglobin (MetHb) in severely sick patients with pneumonia who receive high doses of inhaled...” NCT06950294 ↗ “Inhaled nitric oxide (iNO), which is known mainly from the pulmonary hypertension literature for its therapeutic role in pulmonary arterial hypertension, has been proposed as a...” NCT04996667 ↗ “Inhaled nitric oxide (iNO) has been shown to result in benefits in moderate to vigorous physical activity (MVPA) in patients with fibrotic interstitial lung disease (f-ILD)...” PMID 39141673 ↗ Dec 2024 “One such therapy is inhaled nitric oxide (iNO), which is a selective pulmonary vasodilator that has been shown to reduce total pulmonary resistance and improve systemic venous...” NCT01607983 ↗ “AIMS: Inhalation of nitric oxide (iNO) during myocardial ischaemia and after reperfusion confers cardioprotection in preclinical studies via enhanced cyclic guanosine...” PMID 29800130 ↗ Aug 2018 “BACKGROUND: While inhaled nitric oxide (iNO) has revealed benefit in cardiac arrest in an animal model, no published data has yet demonstrated the impact of iNO in humans with...” PMID 34229057 ↗ Jul 2021 “Adult patients undergoing liver transplantation with prospective intervention involving intraoperative administration of inhaled nitric oxide (iNO) and prospective data collection.” NCT07125443 ↗ “Inhaled nitric oxide (iNO) has been studied as an adjunct treatment to avoid the use of high positive end-expiratory pressure and inspired oxygen in treatment-refractory hypoxia.” PMID 38325012 ↗ Feb 2024 “Study to determine if inhaled nitric oxide (iNO) given through a special delivery device (INOpulse® DS) is safe and efficacious in treating Pulmonary Arterial Hypertension (PAH).” NCT01457781 ↗ “Inhaled nitric oxide (iNO) is an FDA approved drug for the treatment of hypoxic respiratory failure (HRF) in term and late-preterm babies greater than 34 weeks gestation.” NCT01891500 ↗ “Inhaled nitric oxide (iNO) has recently been shown to improve return of spontaneous circulation, survival, and neurological outcome in animal models of cardiac arrest.” NCT05868109 ↗ “Previous clinical trials suggested that inhaled nitric oxide (iNO) could have beneficial effects in sickle cell disease (SCD) patients with acute chest syndrome (ACS).” PMID 26431718 ↗ Oct 2015 “Inhaled nitric oxide (iNO) is a vasodilator that increases cerebral blood flow and is clinically used for hypoxic respiratory failure in neonates and adults.” NCT05616910 ↗ “The active study drug, nitric oxide for inhalation (iNO), will be provided in size 0.074 liter aluminum cartridge at a concentration of 6.0 mg/L (4880 ppm).” NCT04358588 ↗ “Inhaled nitric oxide (iNO) has potential antiinflammatory, antimicrobial, and antiviral properties for patients with lower respiratory tract infections.” PMID 36169967 ↗ Feb 2023 “Inhaled Nitric oxide (iNO), possesses anti-viral properties, improves oxygenation, and was shown to be safe in infants with respiratory conditions.” PMID 32541773 ↗ Jun 2020 “In has also shown invitro and clinical evidence that inhaled nitric oxide gas (iNO) has antiviral activity against other strains of coronavirus.” PMID 32511534 ↗ May 2020 “Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension” NCT05356052 ↗ “inhaled nitric oxide (iNO) has been shown to induce a selective dilation of cerebral arteries and arterioles in hypoperfused brain tissue” NCT04988932 ↗ “The NO is a powerful vasodilator and is used in intensive care in inhaled way as selective pulmonary vasodilator (iNO).” NCT02345616 ↗ “Inhaled nitric oxide (iNO) selectively acts on the pulmonary vasculature of ventilated lung tissue” PMID 38724947 ↗ May 2024 “Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system” NCT00626028 ↗ “Inhaled nitric oxide (iNO) improves oxygenation in term infants with respiratory failure.” NCT00732537 ↗ “inhaled nitric oxide (iNO) reduced the number of deaths” NCT00005773 ↗ “early, noninvasive inhaled nitric oxide (iNO) therapy” PMID 25063725 ↗ Jul 2014 “Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo” NCT04421508 ↗ “inhaled nitric oxide (iNO; a vasodilator)” NCT02851472 ↗ “pulsed, inhaled nitric oxide (iNO)” NCT05747508 ↗ “Inhaled Nitric Oxide (iNO) use” NCT05213676 ↗ “inhaled nitric oxide (INO)” NCT00142051 ↗ “inhaled nitric oxide (iNO)” NCT00006401 ↗ “Inhaled Nitric Oxide (iNO)” NCT02652429 ↗ “Inhaled nitric oxide (iNO)” NCT04398290 ↗ “inhaled nitric oxide (iNO)” NCT00945529 ↗ “Inhaled Nitric Oxide (iNO)” NCT01172691 ↗ “Inhaled Nitric Oxide (iNO)” NCT07544147 ↗ |
| Known as | INO max | “INO max®” NCT00551642 ↗ |
| Known as | INOmax (nitric oxide) for inhalation | “INOmax (nitric oxide) for inhalation” NCT01388842 ↗ |
| Known as | Nitric Oxide Gas | “Drug: Nitric Oxide Gas” NCT04306393 ↗ |
| Known as | NO | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06261827 ↗ |
| Known as | NO, nitrogen monoxide | “NO, nitrogen monoxide” NCT01255215 ↗ |
| Known as | NONI | “This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in...” NCT04443868 ↗ |
| Known as | NONS | “A Double-Blinded, Placebo-Controlled Parallel, Phase 3 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in...” NCT05012319 ↗1“Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19” NCT05599919 ↗ |
| Action | Activate | “NO has been shown to activate CFTR” NCT00570349 ↗ |
| Modality | Other / unclassified | “nitric oxide gas” NCT00545298 ↗ |
| Route | Inhaled | “is given through a cushioned mask placed over the mouth and nose.” NCT00001303 ↗ |
| Target | CFTR | “NO has been shown to activate CFTR” NCT00570349 ↗ |