Nitroglycerin
| Evidence Level: L3 | Predicted Indications: 4 |
Table of Contents
- Nitroglycerin
- Pharmacist Assessment Report
- Nitroglycerin: From Angina (Label Indication to Be Verified) to Pulmonary Hypertension
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Nitroglycerin: From Angina (Label Indication to Be Verified) to Pulmonary Hypertension
One-Sentence Summary
Nitroglycerin is an organic nitrate vasodilator that is widely marketed in India. The approved indication text is not available in the data compiled for this report, but the drug is classically used for angina. The TxGNN model predicts it may be effective for pulmonary hypertension, with 3 clinical trials and 20 publications currently supporting this direction. Most of this evidence is small, early-phase, or consists of older hemodynamic studies and reviews.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the licence records compiled for this report |
| Predicted New Indication | Pulmonary hypertension |
| TxGNN Prediction Score | 0.9961 |
| Evidence Level | L3 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold (research question; not ready for a repurposing decision) |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the compiled data. Based on known pharmacology, nitroglycerin is an organic nitrate that releases nitric oxide (NO). NO activates soluble guanylate cyclase and raises cGMP in vascular smooth muscle, causing vasodilation.
The same NO-cGMP pathway operates in the pulmonary circulation, so lowering pulmonary vascular resistance is mechanistically plausible. Nebulized or inhaled delivery may give relatively selective pulmonary effects with less systemic hypotension. This matters because oral and intravenous nitroglycerin are non-selective and can cause systemic hypotension.
Older hemodynamic studies (1983–1984) reported reductions in pulmonary vascular resistance and pulmonary artery pressure. Recent pediatric and neonatal reports (2021, 2025) support acute vasoreactivity. Data on long-term outcomes are lacking.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT07214129 | Not applicable | Completed | 20 | Nebulized nitroglycerin as a vasoreactive agent in pulmonary arterial hypertension; preliminary feasibility and acute hemodynamic data |
| NCT04594629 | Phase 1 | Unknown | 120 | Nebulized prostacyclin (PGI2) vs nebulized nitroglycerin for pulmonary hypertension after valve replacement surgery; no confirmed results |
| NCT07603037 | Not applicable | Not yet recruiting | 12 | Nicardipine and nitroglycerin effects on ventilation-perfusion ratio in acute respiratory failure; only indirectly relevant |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 40888971 | 2025 | RCT | Eur J Pediatr | Nebulized nitroglycerin as an adjuvant in persistent pulmonary hypertension of the newborn (80 neonates); echocardiographic and clinical parameters assessed |
| 29880427 | 2018 | RCT | J Cardiothorac Vasc Anesth | Dobutamine plus nitroglycerin vs milrinone for perioperative pulmonary hypertension in mitral valve surgery |
| 34082850 | 2021 | Cohort/review | Cardiol Young | Inhaled nitroglycerin for acute pulmonary arterial hypertension in children with congenital heart disease |
| 16707530 | 2006 | Clinical study | Br J Anaesth | Inhaled nitroglycerin reduced pulmonary arterial pressure in children with congenital heart disease |
| 6407380 | 1983 | Hemodynamic study | Ann Intern Med | In 9 patients with chronic pulmonary hypertension, nitroglycerin raised cardiac index about 40% and lowered pulmonary vascular resistance about 40% |
| 6423015 | 1984 | Hemodynamic study | Bull Eur Physiopathol Respir | In 27 COPD patients, only nitroglycerin (not isosorbide dinitrate) lowered pulmonary vascular resistance |
| 3096761 | 1986 | Clinical study | Eur J Respir Dis Suppl | Transdermal nitroglycerin lowered pulmonary artery pressure, sustained over 4 weeks |
| 8908227 | 1996 | Clinical study | Acta Anaesthesiol Scand | Pulmonary vascular effects of nitroglycerin vs isosorbide dinitrate in end-stage cardiomyopathy |
| 42572609 | 2026 | Review | JHLT Open | Inhaled pulmonary vasodilators in the perioperative setting; notes nitroglycerin lacks pulmonary selectivity |
| 39059783 | 2024 | Review | Curr Probl Cardiol | Advances in nebulized inhalation for pulmonary arterial hypertension |
India Market Information
There are 20 valid single-ingredient registrations. The five below are representative; the approved indication text is not recorded for any of them.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 98267 | Glynit 0.5mg Tablet | Strip of 10 tablets | Not recorded |
| 150302 | Nitrolong 2.6 Tablet CR | Bottle of 30 CR tablets | Not recorded |
| 236104 | Vasovin-XL 6.5 Capsule | Bottle of 25 capsules (TR) | Not recorded |
| 134768 | Myonit SR 6.4 Tablet | Bottle of 30 CR tablets | Not recorded |
| 155503 | Nig 50mg Injection | Vial of 10 ml injection | Not recorded |
Most products are oral controlled-release tablets or capsules; one is an injection. No inhaled or nebulized product is registered, which matters because the best-supported pulmonary hypertension evidence involves nebulized delivery.
Safety Considerations
- Disease-level contraindication signals (from the knowledge graph, not label text): hypotensive disorder, hypertrophic cardiomyopathy, methemoglobinemia, sulfhemoglobinemia, anemia, macrocytic anemia, intracerebral hemorrhage, constrictive pericarditis, restrictive cardiomyopathy, and cardiac tamponade.
- Drug Interactions: 228 interactions were identified. Examples of moderate-level interactions include:
- morphine
- bupropion
- the SGLT2 inhibitors canagliflozin, dapagliflozin, and empagliflozin
- dronabinol and nabilone
- sapropterin
- rosiglitazone
Minor-level interactions include anticholinergics (atropine, hyoscyamine, scopolamine, and similar), aspirin, and omeprazole.
- Clinical concern for this indication: systemic vasodilation may cause hypotension. In pulmonary hypertension, a non-selective vasodilator may also worsen ventilation-perfusion matching or right ventricular function.
Please refer to the package insert for label warnings and contraindications, which are not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanism is plausible and acute hemodynamic data are consistent, but the trials are small, early-phase or of unknown status, and none is a confirmatory Phase 3 study. The strongest support is for nebulized delivery, which is not available among the marketed Indian products, and there are no long-term outcome data. This is best treated as a research question rather than a repurposing candidate ready to advance.
To proceed, the following is needed:
- Package insert warnings, contraindications, and approved indications for the Indian products
- Mechanism of action data from DrugBank
- Adequately powered, controlled studies of nebulized or inhaled nitroglycerin with clinically meaningful endpoints
- A suitable inhaled formulation and an assessment of whether it fits the Indian regulatory pathway
- A safety plan addressing hypotension and the drug-interaction burden
Other predicted indications: Prinzmetal angina has an evidence level of L4 and a “Proceed with Guardrails” recommendation. It is largely an established nitrate use rather than true repurposing, so the label status should be verified. Kyphoscoliotic heart disease, primary hereditary glaucoma, and congenital hypotrichosis milia have no trials or literature and a weak or absent mechanistic basis, so all three are on Hold.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.