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Nitroglycerin (glyceryl trinitrate)
Nitroglycerin forms nitric oxide, activating guanylate cyclase and increasing cyclic GMP, leading to smooth muscle relaxation and vasodilation.
Nitroglycerin, also known as glyceryl trinitrate, is a small molecule nitrate vasodilator developed by FOUGERA and currently owned by the same company. It targets the atrial natriuretic peptide receptor 1 and is FDA-approved for the prevention and treatment of angina pectoris, left ventricular cardiac dysfunction, and perioperative hypertension. Nitroglycerin works by relaxing vascular smooth muscle, leading to vasodilation and reduced blood pressure. As a nitrate vasodilator, it is off-patent and has a bioavailability of 1%. Key safety considerations include its short half-life of 4.5 hours and potential for tolerance development.
At a glance
| Generic name | glyceryl trinitrate |
|---|---|
| Also known as | Rectogesic, GTN, MED2005, Topical GTN treatment, Percutol |
| Sponsor | Fougera |
| Drug class | Nitrate Vasodilator [EPC] |
| Target | guanylate cyclase |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1981 |
Mechanism of action
Nitroglycerin works by forming nitric oxide, which activates an enzyme called guanylate cyclase. This activation increases the levels of cyclic GMP in smooth muscle and other tissues, causing the muscles to relax and blood vessels to widen, reducing blood pressure and improving blood flow.
Approved indications
- Angina Pectoris Prevention
- Angina pectoris
- Left ventricular cardiac dysfunction
- Perioperative hypertension
Common side effects
- Syncope
- Marked sensitivity to the hypotensive effects of nitrates
- Flushing
- Drug rash
- Exfoliative dermatitis
- Nausea
- Vomiting
- Weakness
- Diaphoresis
- Pallor
- Collapse
- Headache
Drug interactions
- sildenafil
- tadalafil
- vardenafil
Key clinical trials
- Glyceryl Trinitrate Gel Phonophoresis on Planter Fasciiatis (NA)
- Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow (PHASE3)
- Subcutaneous Nitroglycerin to Facilitate Trans-radial Access. (PHASE4)
- Evaluating the Effects of Nitroglycerin on Heart Function and Urinary Output in Patients With Acute Heart Failure (PHASE4)
- Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy (NA)
- Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule (NA)
- 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 (PHASE1)
- Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nitroglycerin CI brief — competitive landscape report
- Nitroglycerin updates RSS · CI watch RSS
- Fougera portfolio CI