GENOSYL
Peaknitric oxide
NDAINHALATIONGAS
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
GENOSYL (nitric oxide) is cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. Approved for pulmonary hypertension. First approved in 2019.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GENOSYL (nitric oxide) is an inhaled gas vasodilator approved in 2019 for pulmonary hypertension. It works by activating guanylate cyclase to increase cyclic GMP, causing selective pulmonary vasodilation while sparing systemic circulation due to rapid hemoglobin scavenging. The mechanism improves oxygenation by redistributing blood flow toward better-ventilated lung regions.
Peak14.2 years to LOE
Product is at peak commercial stage with specialized delivery mechanism; teams likely focused on differentiation and market 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 (1)
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.