nitric oxide

Trade name: inomax

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 23, 1999

In mammals Nitric Oxide (NO) is an important cellular signaling molecule involved in many physiological and pathological processes. It is a powerful vasodilator with a short half-life of a few seconds in the blood. Low levels of nitric oxide production are important in protecting organs such as the liver from ischemic damage. Nitric oxide production is associated with nonalcoholic fatty liver disease (NAFLD) and is essential for hepatic lipid metabolism under starvation. Nitric oxide (INOmax) is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. Nitric oxide relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. When inhaled, nitric oxide selectively dilates the pulmonary vasculature, and because of efficient scavenging by hemoglobin, has minimal effect on the systemic vasculature. INOmax appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better-ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios. NO, can be generated in large quantities and has detrimental effects on the CNS. NO has been shown to increase permeability of the BBB, allowing substances to enter into the brain passively. Because of its importance in neuroscience, physiology, and immunology, NO was proclaimed "Molecule of the Year" in 1992. Research into its function led to the 1998 Nobel Prize for discovering the role of nitric oxide as a cardiovascular signaling molecule (Furchgott, Murad and Ignarro). — NCATS

Clinical trial activity

192 trials · 178 clinical orgs · 8 marketing orgs

Phase 1
50
Phase 2
124
Phase 3
43
Phase 4
10

Earliest trial started Apr 4, 1992 (NCT00001303)

Timeline

1990s

  1. Jan 1, 1992

    Earliest Phase 1 Sponsor(trial)

  2. Jun 22, 1993

    Orphan Drug Designation

  3. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

  5. Dec 23, 1999

    INO Therapeutics — Earliest FDA Approval

  6. Dec 23, 1999

    INO Therapeutics — NDA Organization

  7. Dec 23, 1999

    Mallinckrodt — NDA Secondary Org

  8. Dec 23, 1999

    International Minerals and Chemical Corporation — NDA Secondary Org

  9. Dec 23, 1999

    Mallinckrodt — Marketing Organization

2010s

  1. Oct 2, 2018

    Praxair — Marketing Organization

  2. Oct 2, 2018

    Linde AG — Marketing Organization

  3. Oct 2, 2018

    BOC International — Marketing Organization

  4. Dec 20, 2019

    Vero Biotech — Marketing Organization

  5. Dec 20, 2019

    Vero Biotech — NDA Secondary Org

2020s

  1. Jul 27, 2023

    AIRGAS THERAP — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 23, 1999

Chemistry & pharmacology

Loading structure…

SMILES

[N]=O
Mol. weight
30.0061 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • edrf
  • edrf
  • endothelium-derived relaxing factor
  • endothelium-derived relaxing factor
  • inomax
  • inomax
  • inomax
  • inomax
  • mononitrogen monoxide
  • mononitrogen monoxide
  • monoxido de nitrogeno
  • monoxido de nitrogeno
  • monoxyde d'azote
  • monoxyde d'azote
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitric oxide
  • nitrogen monooxide
  • nitrogen monooxide
  • nitrogen monoxide
  • nitrogen monoxide
  • nitrogen monoxide
  • nitrogen monoxide
  • nitrogen monoxide
  • nitrogen oxide
  • nitrosyl
  • nitrosyl
  • no
  • no
  • (.)no
  • (.)no
  • (no)(.)
  • (no)(.)
  • [no]
  • [no]
  • no(.)
  • no(.)
  • oxido de nitrogeno(ii)
  • oxido de nitrogeno(ii)
  • oxido nitrico
  • oxido nitrico
  • oxyde azotique
  • oxyde azotique
  • oxyde nitrique
  • stickstoff(ii)-oxid
  • stickstoff(ii)-oxid
  • stickstoffmonoxid
  • stickstoffmonoxid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07247240Phase 4Nov 30, 2025Chungnam National University, Seoul National University, University of Ulsan, Yonsei University
NCT06950294Early Phase 1 (Phase 1)Jun 30, 2025Harvard University
NCT06702553Phase 3Dec 15, 2024Xijing Hospital
NCT06636357Phase 2Nov 1, 2024University of Zurich
NCT06622291Phase 4Oct 8, 2024Capital Medical University
NCT06539013N/AAug 1, 2024Saglik Bilimleri Universitesi
NCT05871606Phase 1Apr 30, 2024Mallinckrodt, Wake Forest University
NCT06249633Early Phase 1 (Phase 1)Feb 29, 2024Cedars-Sinai Medical Center, Mallinckrodt
NCT06261827N/AFeb 20, 2024Russian Academy of Medical Sciences
NCT06264141Phase 2Jan 16, 2024Sanotize Research and Development Corp.
NCT06170372N/AJan 15, 2024Russian Academy of Medical Sciences
NCT06120816Phase 1Dec 31, 2023Sanotize Research and Development Corp.
NCT06213077N/ADec 12, 2023OnSite Clinical Solutions, RHA Investments Ltd
NCT06162455N/ANov 17, 2023Russian Academy of Medical Sciences
NCT06097026N/AOct 25, 2023Air Liquide, Universidad Autonoma de Madrid
NCT05616910Phase 2Aug 31, 2023University of Pennsylvania
NCT05877313Phase 2Aug 2, 2023Sanotize Research and Development Corp.
NCT05801224N/AAug 1, 2023Harvard University
NCT05896800N/AJun 1, 2023Nanjing Medical University
NCT05757557Phase 1/Phase 2 (Phase 2)Feb 25, 2023Russian Academy of Medical Sciences
Showing 20 of 192 trials
Page 1 / 10

Organizations

Research & Development (178)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MallinckrodtFor profit411551998
Harvard UniversityAcademic/Hospital171442005
Bellerophon TherapeuticsFor profit131042012
Sanotize Research and Development Corp.For profit9932019
National Heart, Lung, and Blood Institute (NHLBI)Government7332000
Russian Academy of Medical SciencesAcademic/Hospital7722015
University of CincinnatiAcademic/Hospital7311995
National Institutes of Health (NIH)Government6331992
Nitric BioTherapeutics, IncFor profit6512005
University of Alabama, BirminghamAcademic/Hospital6231998
Xijing HospitalAcademic/Hospital6522013
Indiana UniversityAcademic/Hospital5121995
Advanced Inhalation Therapies LtdFor profit4422013
Baylor UniversityAcademic/Hospital4221995
Novan, Inc.For profit4432017
Stanford UniversityAcademic/Hospital4121995
University of AlbertaAcademic/Hospital4412018
University of Texas at HoustonAcademic/Hospital4121998
A.O. Ospedale Maggiore di LodiAcademic/Hospital3012020
Beyond Air LtdFor profit3322019
178 organizations
Page 1 / 9

Marketing (11)

OrganizationOrg typeRelationshipDate
AIRGAS THERAPFor profitMKTGJul 27, 2023
BOC InternationalFor profitMKTGOct 2, 2018
INO TherapeuticsFor profitNDADec 23, 1999
International Minerals and Chemical CorporationFor profitNDA2Dec 23, 1999
Linde AGFor profitMKTGOct 2, 2018
MallinckrodtFor profitNDA2Dec 23, 1999
MallinckrodtFor profitMKTGDec 23, 1999
PraxairFor profitMKTGOct 2, 2018
Vero BiotechFor profitMKTGDec 20, 2019
Vero BiotechFor profitSYNDec 20, 2019
Vero BiotechFor profitNDA2Dec 20, 2019