NDAINJECTIONINJECTABLE
Approved
Jan 1983
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
NITROL (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 1983.
Drug data last refreshed 9h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NITROL (nitroglycerin) is an injectable vasodilator approved in 1983 that works by activating nitric oxide-dependent guanylate cyclase, increasing cyclic GMP and causing smooth muscle relaxation and vasodilation. It is indicated for acute management of coronary artery disease, heart failure, hypertension, and related cardiovascular conditions. The drug is particularly valuable in acute care settings for rapid hemodynamic stabilization.
LOE Approaching
As LOE approaches, the brand team will shift focus to generic defense, therapeutic positioning, and managed care negotiations to maintain market presence.
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.
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 Sep 2026
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.