GENOSYL
Peaknitric oxide
NDAINHALATIONGAS
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
GENOSYL (nitric oxide) is cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. First approved in 2019.
Drug data last refreshed 19h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GENOSYL is an inhaled nitric oxide gas approved in December 2019 for pulmonary vasodilation. It works by activating guanylate cyclase to increase cyclic GMP, selectively dilating pulmonary vessels and improving ventilation/perfusion matching in the lungs. When inhaled, it redistributes blood flow to better-ventilated lung regions, improving arterial oxygen partial pressure.
Peak13.8 years to LOE
Product is at peak maturity with strong patent protection extending to 2040; commercial team size likely stable with focus on market penetration and physician engagement.
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.