NDAINHALATIONGASPriority Review
Approved
Dec 1999
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
INOMAX (nitric oxide) by Mallinckrodt Ireland 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 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INOMAX is an inhaled nitric oxide gas approved in 1999 for selective pulmonary vasodilation. It works by activating guanylate cyclase to increase cGMP, leading to vasodilation preferentially in well-ventilated lung regions and improving oxygenation. The drug is used in critical care settings, particularly for neonates and acute respiratory distress syndrome patients requiring intensive hemodynamic support.
Peak10.0 years to LOE
Established peak-stage product with niche critical care market positioning; teams focus on retention, protocol optimization, and device integration rather than expansion.
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)
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Started Sep 2026
102 enrolled
Diabetic Foot Ulcers (DFUs)
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Started Nov 2025
900 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
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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.