Candesartan
| Evidence Level: L2 | Predicted Indications: 9 |
Table of Contents
Candesartan: Migraine disorder
One-Sentence Summary
Candesartan is an angiotensin II type 1 receptor blocker used for hypertension. The TxGNN model predicts it may be effective for migraine disorder, with a prediction score of 0.9997. Support comes from 4 clinical trials (3 directly on migraine) and 20 publications, including a placebo-controlled randomised trial published in The Lancet Neurology (2025). The evidence level is L2.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 0.9997 |
| Evidence Level | L2 |
| India Market Status | Listed in a compiled Indian medicine price dataset (20 of 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | 20 (valid: 20) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Candesartan blocks the angiotensin II type 1 (AT1) receptor, which is expressed in vascular and neural tissue. Detailed mechanism-of-action data are not available in the compiled data, but several mechanisms have been proposed for migraine prevention. These include modulation of the renin-angiotensin system in cerebrovascular and trigeminovascular tissue, reduced neuroinflammation and oxidative stress, lower susceptibility to cortical spreading depression, and modulation of sympathetic tone and vascular reactivity.
Several guideline-oriented reviews list candesartan as a preventive option for migraine, and a recent scoping review (2025) examined its use for this purpose. This is consistent with the high prediction score. Direct trial data now exist in the target disease, so the prediction is supported by clinical studies and not by model output alone.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT04574713 | Phase 2 | Completed | 450 | Multicentre, triple-blind, placebo-controlled, parallel-group trial of candesartan 8 mg and 16 mg for migraine prevention |
| NCT00884663 | Phase 2/3 | Completed | 72 | Double-blind, double-dummy, placebo-controlled triple cross-over comparison of candesartan with propranolol for migraine prevention |
| NCT04138316 | N/A (observational) | Completed | 85 | Spanish real-world study of response predictors and tolerability in patients with episodic or chronic migraine after three or more failed preventives |
| NCT07655440 | Phase 4 | Not yet recruiting | 120 | Compares migraine preventives with anti-CGRP therapies for tinnitus in migraine patients; indirect relevance, no results yet |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 40975098 | 2025 | RCT | The Lancet Neurology | Randomised, triple-blind, placebo-controlled phase 2 trial of candesartan for episodic migraine prevention, assessing safety, tolerability and efficacy |
| 38663908 | 2024 | Observational | Cephalalgia | CandeSpartan study of effectiveness, tolerability and response predictors in routine practice; notes two earlier randomised trials supporting efficacy |
| 40571531 | 2025 | Scoping Review | Clinical Therapeutics | Reviews candesartan as a potential migraine treatment |
| 37350141 | 2023 | Systematic Review / Meta-analysis | Cephalalgia | Effect of blood-pressure-lowering drugs on episodic migraine prevention |
| 39899861 | 2025 | Clinical Guideline | Annals of Internal Medicine | American College of Physicians guideline on drug prevention of episodic migraine |
| 39365169 | 2024 | Systematic Review | Health Technology Assessment | Preventive drugs for chronic migraine, with economic modelling |
| 38057728 | 2023 | Systematic Review / Network Meta-analysis | J Headache Pain | Comparative effectiveness of preventive drugs for chronic migraine |
| 38307673 | 2024 | Review | Handbook of Clinical Neurology | Non-specific oral preventives, including candesartan |
| 34048395 | 2021 | Review | Continuum | Overview of preventive migraine treatment |
| 18759728 | 2008 | Review | Med J Aust | Evidence for candesartan in migraine prophylaxis described as reasonably good but limited |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 37021 | Candesar 4mg Tablet (Sun Pharmaceutical Industries Ltd) | Strip of 10 tablets | Not stated |
| 38999 | Cantar 8mg Tablet (Dr Reddy’s Laboratories Ltd) | Strip of 10 tablets | Not stated |
| 36620 | Candelong 8mg Tablet (Micro Labs Ltd) | Strip of 10 tablets | Not stated |
| 39959 | Canditor 8 Tablet (Johnlee Pharmaceuticals Pvt Ltd) | Strip of 10 tablets | Not stated |
| 44780 | Candosa 8 Tablet (AAR ESS Remedies Pvt Ltd) | Strip of 10 tablets | Not stated |
All 20 licences in the local data are valid. The approved indication is not recorded in the local data.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Two randomised, placebo-controlled trials (a completed Phase 2/3 crossover study and a large Phase 2 parallel-group study published in 2025) plus an observational study support candesartan for migraine prevention. There are no multiple Phase 3 trials or systematic reviews of randomised trials specific to candesartan, so the evidence level is L2.
To proceed, the following is needed:
- Phase 3 confirmation, or an independent replication of the Phase 2 results
- Detailed mechanism-of-action data
- Safety information from the package insert, including blood pressure monitoring in normotensive migraine patients
- Confirmation of the approved indication text in the local licence records
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.