NDASUBLINGUALTABLET
Approved
May 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
NITROSTAT (nitroglycerin) by Viatris (2) is (no) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic gmp) in smooth muscle and other tissues. First approved in 2000.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NITROSTAT is a sublingual tablet containing nitroglycerin, a nitrate vasodilator approved in 2000 for acute angina relief. It works by releasing nitric oxide (NO) which activates guanylate cyclase, increasing cyclic GMP in smooth muscle and causing rapid vasodilation of coronary and peripheral blood vessels. The mechanism reduces preload and afterload on the heart, alleviating chest pain within minutes.
LOE Approaching
As LOE approaches, the brand team is likely consolidating around maintenance activities and preparing for generic erosion; expect stable but not expanding headcount.
Mechanism of Action
(NO) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle and other tissues. These events lead to dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle, and result in vasodilatation.
Pharmacologic Class:
Nitrate Vasodilator
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
A Study to Learn About How Safe Nitroglycerin is and How it Affects the Body When Taken Along With Nurandociguat in People With Coronary Artery Disease
Started Oct 2026
36 enrolled
Stable Coronary Artery Disease
Evaluating MED2005 & Nitrostat Bioavailability
Started Nov 2017
40 enrolled
Erectile Dysfunction
Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients
Started Nov 2015
36 enrolled
Coronary Artery Disease
Safety of Nitroglycerin for Field Treatment of STEMI
Started Jun 2015
940 enrolled
Myocardial Infarction
Treatment of Suspected Cholelithiasis With Nitroglycerin
Started Oct 2014
62 enrolled
COLICBILIARY TRACT DISEASES
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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.