INOMAX
Peaknitric oxide
NDAINHALATIONGASPriority Review
Approved
Dec 1999
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
INOMAX (nitric oxide) is cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. First approved in 1999.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INOMAX (nitric oxide) is an inhaled vasodilator gas approved in 1999 that selectively dilates pulmonary vessels by activating guanylate cyclase and increasing cyclic GMP. It improves oxygenation in patients with pulmonary hypertension by redistributing blood flow to better-ventilated lung regions, minimizing systemic effects due to rapid hemoglobin scavenging. The product is used in critical care settings, particularly in neonatal and adult respiratory failure.
Peak10.4 years to LOE
Established peak-stage product with stable market position; team size likely mature with focus on retention and operational excellence rather than aggressive growth.
Mechanism of Action
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…
Pharmacologic Class:
Vasodilator
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.
Started Jul 2026
102 enrolled
Diabetic Foot Ulcers (DFUs)
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Started Nov 2025
600 enrolled
Congenital Diaphragmatic Hernia
Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass
Started May 2025
3,650 enrolled
Nitric OxideCardiac SurgeryCardiopulmonary Bypass+1 more
Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
Started Dec 2024
120 enrolled
Pulmonary HypertensionHypoxic Respiratory Failure
Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome
Started Oct 2024
1,260 enrolled
Acute Respiratory Distress Syndrome
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.