INOmax
(Nitric Oxide)ApprovedSmall molecule
Nitric oxide is a gas that is inhaled to help improve oxygen levels in newborns and infants with severe lung problems, particularly those with a condition where the blood vessels in the lungs are too constricted.[2] INOmax is currently approved and in use across 66 indications[4].[1]
INOmax is one of 1184 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.
66
Indications
68
Total Trials
4
Active Trials
1,183
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
46
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 65 indications
Competition
Competitive Landscape
1931 competitors in COVID-19
#DrugCompanyPhaseTrials
1INOmax
MMallinckrodt
Approved
Bnt162b2
BioNTechPreclinical
Proventil
Mylan Pharmaceuticals IncPreclinical
Glucocorticoid
AbbViePreclinical
HB-Admscs
HHope Biosciences Research Foundation
Preclinical
Aprotinin
BayerPreclinical
Biological Collection
AAssistance Publique - Hôpitaux de Paris
Preclinical
Antihypertensive Agents
NNational Heart, Lung, and Blood Institute (NHLBI)
Preclinical
Antithrombin-III
OctapharmaPreclinical
Interferon-Gamma
SSPP Pharmaclon Ltd.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Clinical
Trials by Indication[1]
Nitric Oxide13 trials
Show 10 more trials
The Effect of Inhaled Nitric Oxide on Deadspace in COPD
Completed·—·Phase 1·NCT04069052·13 enrolled
Inhaled Nitric Oxide for Pediatric Painful Sickle Crisis
Terminated·—·Phase 2·NCT00142051·18 enrolled
COVID-196 trials
Cardiopulmonary Bypass5 trials
Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
Completed·TTomsk National Research Medical Center of the Russian Academy of Sciences·Phase 1/2·NCT03500783·60 enrolled
Pulmonary Hypertension4 trials
Bronchiolitis3 trials
34 more indications
Pulmonary Embolism2 trials
Inhaled Nitric Oxide (iNO) in Post-Pulmonary Embolism (Post-PE)
Completed·—·N/A·NCT04920695·16 enrolled
Acute Respiratory Distress Syndrome2 trials
Nitric Oxide Administration for Acute Respiratory Distress Syndrome
Completed·—·Phase 3·NCT00240487·52 enrolled
Myocardial Infarction2 trials
Bronchopulmonary Dysplasia1 trial
Hypoxia1 trial
Cystic Fibrosis1 trial
After Cardiac Surgery1 trial
Lung Transplantation1 trial
Interstitial Lung Disease1 trial
Children1 trial
Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely
Completed·—·Phase 4·NCT00390065·108 enrolled
Idiopathic Pulmonary Fibrosis1 trial
Inhaled Nitric Oxide (iNO) in Idiopathic Pulmonary Fibrosis (IPF).
Recruiting·—·Phase 1·NCT05052229·40 enrolled
Liver Transplant1 trial
Tinea Pedis1 trial
Cardiac Surgical Patients1 trial
Ventricular Function1 trial
Plantar Wart1 trial
Staphylococcus Aureus1 trial
Chronic Rhinosinusitis1 trial
Diabetic Neuropathy1 trial
A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy
Completed·—·Phase 2·NCT01633086·24 enrolled
ESS1 trial
Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH
Completed·—·Phase 2·NCT02734953·10 enrolled
Safety and Efficacy1 trial
Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore
Unknown status·—·Phase 1/2·NCT01351493·40 enrolled
Candidiasis1 trial
Acute Kidney Injury1 trial
Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection Patients
Completed·—·Phase 4·NCT06622291·106 enrolled
Chronic Lung Disease1 trial
Endothelial Dysfunction1 trial
Unspecified1 trial
NO During CPB in Neonates to Reduce Risk of AKI
Recruiting·—·Phase 3·NCT04216927·40 enrolled
Regulatory
FDA Approval Timeline[5]
Dec 23, 1999
INOMAX
NDA NDA020845
Dec 20, 2019
GENOSYL
NDA NDA202860
Sources
References
- [1]
- [2]MedlinePlus Drug Information — INOmax drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Nitric Oxide. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for INOmax. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Soluble Guanylate Cyclase Activator[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- MMallinckrodt
Patent Landscape[6]
Patent Cliff
Oct 17, 2026
Earliest patent expiration — generic entry possible after this date
Patent #Expires
8057742Jan 18, 2026
7618594Oct 17, 2026
7947227Oct 17, 2026
7560076Apr 21, 2027
9701538Jan 28, 2029
41 more patents
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