NDASUBLINGUALAEROSOL
Approved
Oct 1985
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
6
Data completeness
5/8 — Partial
NITROLINGUAL (nitroglycerin) by Pfizer 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 1985.
Drug data last refreshed 57m ago · AI intelligence enriched 57m ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NITROLINGUAL is a sublingual aerosol formulation of nitroglycerin, a nitrate vasodilator approved in 1985 for acute angina relief. It works by releasing nitric oxide (NO) to activate guanylate cyclase, increasing cyclic GMP in smooth muscle and triggering vasodilation. This mechanism provides rapid symptom relief in patients experiencing acute coronary events.
$0.036BPart D
LOE Approaching2.5 years to LOEProduct approaching loss of exclusivity in 2029 with minimal Part D claims signals a mature, low-volume franchise facing significant generic erosion and reduced team expansion opportunities.
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. This eventually leads to dephosphorylation of myosin light chains, which regulates the contractile state in smooth muscle and results 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 (6)
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 Jan 2027
36 enrolled
Stable Coronary Artery Disease
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
The Effect of Nitroglycerin on the Intrauterine Device (IUD) Insertion Experience in Nulliparous Women
Started Mar 2012
24 enrolled
ContraceptionPain
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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.