Isosorbide Mononitrate

Evidence Level: L5

Predicted Indications: 10

Isosorbide Mononitrate

Pharmacist Assessment Report

Isosorbide Mononitrate: From Angina-Type Nitrate Therapy to hypertrichosis (disease) (Top Prediction)

Note: The data compiled for this report do not include the approved indication text for the Indian licenses. The drug’s original use is therefore described from general pharmacological knowledge (an organic nitrate vasodilator used in ischaemic heart disease) and not from the licence records.

One-Sentence Summary

Isosorbide mononitrate is an organic nitrate vasodilator, a nitric oxide (NO) donor that is marketed in India and is generally used for ischaemic heart disease. The TxGNN model’s top-ranked prediction is hypertrichosis, but there are 0 clinical trials and 0 publications supporting it. This is a model prediction only. The only prediction with any related literature is pulmonary arterial hypertension (rank 10, 2 indirect publications, no trials).

Quick Overview

Item	Content
Original Indication	Not stated in the available licence data
Predicted New Indication	Hypertrichosis (disease)
TxGNN Prediction Score	1.0000
Evidence Level	L5
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

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the compiled data. Based on general pharmacology, isosorbide mononitrate is an NO donor. It raises cGMP in vascular smooth muscle and causes vasodilation.

The link to hypertrichosis is speculative. Vasodilators such as minoxidil are known to cause hypertrichosis, and improved follicular perfusion through NO/cGMP signalling has been discussed in hair biology. No evidence shows that isosorbide mononitrate has this effect. The high score is best read as a model output without clinical support.

The other top-ranked predictions are even less plausible. They are mostly congenital or genetic conditions: Ambras syndrome, hair shaft abnormalities, congenital hypotrichosis, and Dandy-Walker or dental malformation syndromes. Their mechanisms are unrelated to a nitrate vasodilator. Their scores come from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. Alopecia and diffuse alopecia areata have only indirect or no mechanistic support. Alopecia areata is autoimmune, and nitrate vasodilation does not address it.

Pulmonary arterial hypertension (PAH) is the most biologically plausible candidate (score 0.9994, evidence level L4). PAH involves impaired NO-sGC-cGMP signalling, which parallels approved PDE5 inhibitors and sGC stimulators such as riociguat. However, organic nitrates have not shown benefit in PAH. They may also cause tolerance and ventilation/perfusion mismatch, and there are no PAH-specific trials. This is a research question, not a treatment recommendation.

Clinical Trial Evidence

Currently no related clinical trials registered for hypertrichosis or any other predicted indication.

Literature Evidence

No literature is available for hypertrichosis. The only literature found relates to the PAH prediction, and both papers are indirect.

PMID	Year	Type	Journal	Key Findings
16422873	2005	Clinical hemodynamic study	J Sex Med	Hemodynamic effects of sildenafil and isosorbide mononitrate in men with coronary artery disease and erectile dysfunction. The population did not have PAH.
29705351	2018	Preclinical animal study	Life Sci	Stimulation of NO-sensitive soluble guanylate cyclase in monocrotaline-induced pulmonary hypertensive rats. Isosorbide mononitrate was not tested directly.

India Market Information

There are 20 valid single-ingredient licences. The approved indication text is not provided in the licence records. Five examples are listed below.

Authorization Number	Product Name	Dosage Form	Approved Indication
158789	Natriem 60mg Tablet (Emcure)	Strip of 10 tablets	Not stated
134325	Monit 20 Tablet (Intas)	Strip of 15 tablets	Not stated
107828	Ismo Retard Tablet ER (Abbott)	Strip of 7 extended-release tablets	Not stated
136199	Monotrate SR 60 Tablet (Sun Pharma)	Strip of 10 prolonged-release tablets	Not stated
142358	Monocontin 50mg Tablet (Modi Mundi Pharma)	Strip of 7 tablets	Not stated

All products are oral formulations (tablets, sustained-release tablets and capsules).

Safety Considerations

Contraindications (from knowledge graph, not label text): The TxGNN knowledge graph links the drug to these conditions: hypotensive disorder, hypertrophic cardiomyopathy, myocardial infarction, coronary thrombosis, hemoglobinopathy, anaemia (including macrocytic anaemia), hyperthyroidism, Graves disease, thyrotoxicosis, and intracerebral haemorrhage.
Drug Interactions: 189 interactions were recorded. Examples classified as Moderate include bupropion, morphine, opium, dronabinol, nabilone, sapropterin, and the SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin), as well as rosiglitazone. Omeprazole is classified as Minor. Several others (for example calcitriol, pantoprazole, glimepiride and metformin) have an unknown severity level.

Package insert warnings were not available. Please refer to the package insert for full safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The top predictions (hypertrichosis, alopecia and related hair or congenital disorders) rest on model scores alone. They have no trials, no literature, and no credible mechanism (evidence level L5). PAH is mechanistically plausible but only weakly and indirectly supported (L4), and clinical experience suggests nitrates are not effective there. Repurposing is not supported at present.

To proceed, the following is needed:

Package insert warnings and contraindications from Indian regulatory sources, which are currently a blocking gap
Mechanism of action data from DrugBank
Approved indication text for the Indian licences
For PAH, a focused review of nitrate tolerance and V/Q mismatch, followed by preclinical or small haemodynamic studies before any clinical development
For hair-related indications, mechanistic or preclinical data showing a follicular effect, and a safety assessment of hypotension given the vasodilator action
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.