Fimasartan

Evidence Level: L5

Predicted Indications: 3

Fimasartan

Pharmacist Assessment Report

Fimasartan: From Hypertension to Pulmonary Hypertension Owing to Lung Disease and/or Hypoxia

One-Sentence Summary

Fimasartan is an angiotensin II receptor blocker originally used to treat hypertension. The TxGNN model predicts it may be effective for pulmonary hypertension owing to lung disease and/or hypoxia, but at present there are 0 clinical trials and only 1 preclinical publication (in myocardial ischemia/reperfusion injury, not pulmonary hypertension), so this remains largely a computational prediction.

Quick Overview

Item	Content
Original Indication	Hypertension (hypertensive disorder)
Predicted New Indication	Pulmonary hypertension owing to lung disease and/or hypoxia
TxGNN Prediction Score	0.9920
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (3 of 3) – CDSCO approval status is not included in this data
Number of Listed Products	3 (valid: 3)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, fimasartan belongs to the angiotensin II type 1 receptor (AT1R) blocker class. Its efficacy in hypertension is established, and mechanistically it may be applicable to pulmonary hypertension.

Activation of the renin-angiotensin system is implicated in pulmonary vascular remodelling and hypoxic pulmonary vasoconstriction, so blocking AT1R is biologically plausible as a way to modulate pulmonary vascular tone. Both conditions involve elevated vascular pressure, which gives some conceptual similarity.

However, the only linked publication is a preclinical animal study of fimasartan in myocardial ischemia/reperfusion injury, which does not address pulmonary hypertension. The high TxGNN score is a computational output and is not supported by direct clinical or pulmonary-specific data.

Other predicted indications share the same limitation (all are model predictions with no trials):

Pulmonary hypertension with unclear multifactorial mechanism (score 0.9920, evidence level L5)
Malignant hypertensive renal disease (score 0.9916, L5). This is closer to an extension of the original hypertension indication and would need dedicated renal and safety data.
Malignant renovascular hypertension (score 0.9916, L5). The mechanism is coherent, but ARBs carry a recognised concern in bilateral renal artery stenosis or stenosis in a solitary kidney.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
23642815	2013	Preclinical (animal model)	International Journal of Cardiology	Investigated the cardioprotective effect of fimasartan against myocardial ischemia/reperfusion injury and the mechanism by which it reduces mitochondrial damage. Not specific to pulmonary hypertension.

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
Registration No. 86357	Fimagen 60 Tablet (Ajanta Pharma Ltd)	Strip of 10 tablets	Not specified
Registration No. 87924	Fimanta 120 Tablet (Ajanta Pharma Ltd)	Strip of 10 tablets	Not specified
Registration No. 85681	Fimanta 60 Tablet (Ajanta Pharma Ltd)	Strip of 10 tablets	Not specified

Safety Considerations

Please refer to the package insert for safety information.

For the predicted indications, the following class-level cautions apply: ARBs may cause acute renal function decline in bilateral renal artery stenosis or stenosis in a solitary kidney, and hyperkalaemia and acute kidney injury risk would need specific evaluation in any renal indication.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction is supported only by a high model score and a plausible class-level mechanism. There are no clinical trials, and the sole publication is a preclinical study in a different condition. Package insert safety data are also missing.

To proceed, the following is needed:

Mechanism of action data for fimasartan (e.g., from DrugBank)
Package insert warnings and contraindications from the manufacturer (Ajanta Pharma), to enable safety screening
Pulmonary-hypertension-specific preclinical evidence (e.g., hypoxia-induced pulmonary hypertension models)
Review of the hemodynamic and renal safety profile in the target population before any clinical study design
Disclaimer

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