Efonidipine

Evidence Level: L5

Predicted Indications: 3

Efonidipine

Pharmacist Assessment Report

Efonidipine: Pulmonary hypertension with unclear multifactorial mechanism

One-Sentence Summary

Efonidipine is a calcium channel blocker originally used to treat hypertension. The TxGNN model predicts it may be effective for pulmonary hypertension (with unclear multifactorial mechanism), but no clinical trials and no directly relevant publications currently support this direction, so the prediction remains model-based only.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Pulmonary hypertension with unclear multifactorial mechanism
TxGNN Prediction Score	0.9914
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (7 of 7) – CDSCO approval status is not included in this data
Number of Listed Products	7 (valid: 7)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available from the data compiled for this report. Based on known information, efonidipine is a dual L-type/T-type calcium channel blocker with vasodilatory activity, and its blood-pressure-lowering efficacy in systemic hypertension is established (it is authorised for this use in Japan and India). Mechanistically, it may be applicable to pulmonary hypertension, because pulmonary vascular tone and smooth muscle proliferation also depend on calcium signalling.

Other predictions from the model follow a similar pattern:

Pulmonary hypertension owing to lung disease and/or hypoxia (score 0.9914): hypoxia-driven pulmonary vasoconstriction and remodelling involve calcium signalling and the HIF-1 pathway. The only related publication is an in vitro study of a different drug, cilnidipine, which is class-level hint at best.
Malignant hypertensive renal disease and malignant renovascular hypertension (both 0.9904): these are close to the approved use. Efonidipine’s vasodilation of glomerular arterioles gives a rationale for renal protection. However, these are more severe disease forms than the labelled use, and no trials or literature were found.

The mechanistic rationale is therefore plausible but speculative.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

No publications directly support efonidipine in pulmonary hypertension. Two indirect publications were found for the hypoxia-related prediction:

PMID	Year	Type	Journal	Key Findings
19374868	2009	Preclinical (in vitro)	European Journal of Pharmacology	Compared several L-type calcium channel blockers (including efonidipine) on HIF-1 activity in vascular cells; the title highlights selective suppression by cilnidipine, a different drug
7557732	1995	Preclinical (animal)	Nihon Yakurigaku Zasshi	Efonidipine showed protective effects in mouse and rat models of cerebral ischaemia and anoxia; not related to pulmonary hypertension

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
72675	Efnocar 20 Tablet	Strip of 10 tablets	Not stated
73173	Efonta 20 Tablet	Strip of 15 tablets	Not stated
76085	Efnocar 10mg Tablet	Strip of 10 tablets	Not stated
72455	Efnocar 40 Tablet	Strip of 10 tablets	Not stated
72983	Efonta 40mg Tablet	Strip of 15 tablets	Not stated

Seven valid registrations exist in total (the two not shown are Efnocar-MX 40/25 Tablet MR and Efonta T 20mg/40mg Tablet).

Review correction (2026-11-06): Originally stated: “Seven valid single-ingredient registrations exist in total (the two not shown are Efnocar-MX 40/25 Tablet MR and Efonta T 20mg/40mg Tablet).” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Safety Considerations

Please refer to the package insert for safety information.

One pharmacology record indicates that efonidipine acts on the Cav3.2 (T-type calcium channel, CACNA1H) target; no specific drug–drug interactions were identified in the data compiled for this report.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction score is high (0.9914), but there are no clinical trials and no efonidipine-specific publications for pulmonary hypertension, so the evidence is at the model-prediction level only (L5). The mechanistic rationale is plausible but unverified, and the key safety information is missing.

To proceed, the following is needed:

Package insert warnings and contraindications from the India market (currently blocking for safety screening)
Detailed mechanism of action data (MOA)
Preclinical studies of efonidipine in pulmonary hypertension models (e.g., hypoxia-induced or monocrotaline models)
A literature search focused on efonidipine and pulmonary vascular effects
Safety assessment for pulmonary hypertension populations, including haemodynamic effects of systemic vasodilation
Review of the closer-to-label predictions (malignant hypertensive renal disease, malignant renovascular hypertension) as possibly lower-risk alternatives to explore

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-11-06	Removed: “single-ingredient”	Corrected	Indian Medicine Dataset

Disclaimer

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