Doxazosin
| Evidence Level: L4 | Predicted Indications: 2 |
Table of Contents
Doxazosin: Migraine disorder
One-Sentence Summary
Doxazosin is an alpha-1 adrenergic blocker originally used to treat hypertension and benign prostatic hyperplasia. The TxGNN model predicts it may be effective for migraine disorder, but the supporting evidence is thin: no registered clinical trials and only 1 publication (a small case series from 1997).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 0.9920 |
| Evidence Level | L4 |
| India Market Status | Listed in a compiled Indian medicine price dataset (8 of 8) – CDSCO approval status is not included in this data |
| Number of Listed Products | 8 (valid: 8) |
| 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 general knowledge of the drug class, doxazosin is an alpha-1 adrenergic antagonist. Its efficacy in hypertension and benign prostatic hyperplasia is established, and it acts by relaxing vascular and prostatic smooth muscle.
Adrenergic signaling influences cerebrovascular tone and sympathetic activity, both plausibly involved in migraine. Other adrenergic-modulating drugs, such as propranolol and clonidine, have been used for migraine prophylaxis. This gives a plausible but indirect rationale for the prediction.
The very high TxGNN score is a computational prediction only and is not clinical evidence. The mechanistic link here rests on general class knowledge rather than on supplied mechanism data.
A second predicted indication, migraine with brainstem aura (score 0.9919), has no direct clinical or literature support. Its score likely reflects its close relationship to migraine disorder rather than independent evidence, so it remains prediction-only (L5, Hold).
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 9074296 | 1997 | Review (small case series) | Headache | Ten migraine patients in a general neurology practice received terazosin or doxazosin. Migraine frequency and/or severity decreased in all but one patient, but five discontinued because of side effects. No serious adverse reactions were reported. |
This is a very small, uncontrolled report and cannot establish efficacy.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 59845 | Doxacard 4 Tablet (Cipla Ltd) | Strip of 10 tablets | Not stated in records |
| 64626 | Doxapress 2mg Tablet (Micro Labs Ltd) | Strip of 10 tablets | Not stated in records |
| 217969 | Tendura Tablet (Adeka India Private Limited) | Strip of 10 tablets | Not stated in records |
| 66014 | Doxapress 1mg Tablet (Micro Labs Ltd) | Strip of 10 tablets | Not stated in records |
| 61421 | Duracard 2mg Tablet (Sun Pharmaceutical Industries Ltd) | Strip of 10 tablets | Not stated in records |
Eight valid single-ingredient registrations exist in total, all oral tablets, with none cancelled. The table lists five of them.
Safety Considerations
- Disease-level contraindication signals (knowledge graph, not label text): multiple system atrophy, postural orthostatic tachycardia syndrome, orthostatic hypotension, hypotensive disorder, liver failure, liver disease, gallbladder disease, pyloric stenosis, intestinal obstruction, priapism, and intraoperative floppy iris syndrome.
- Drug Interactions: 185 interactions were identified in total. Moderate-level interactions include:
- Corticosteroids: hydrocortisone, triamcinolone, dexamethasone, betamethasone, budesonide, prednisolone, prednisone
- SGLT2 inhibitors: canagliflozin, dapagliflozin, empagliflozin, ertugliflozin
- Opioids: morphine, opium
- Cannabinoids: dronabinol, nabilone
- Others: bupropion, clarithromycin
Interactions with calcitriol, clotrimazole, and cimetidine are of unknown severity.
Package insert warnings and contraindications were not available for this report. Please refer to the package insert for full safety information.
The orthostatic hypotension and hypotension signals are especially relevant for a migraine population. The 1997 case series also reported that half of the patients stopped treatment because of side effects.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is mechanistically plausible but rests on a very high model score, a single small uncontrolled case series, and no registered clinical trials. This is not enough to justify moving forward.
To proceed, the following is needed:
- Mechanism of action data for doxazosin, to strengthen the link to migraine
- Package insert warnings and contraindications from the India regulator, to complete safety screening
- Controlled clinical evidence (at least a well-designed Phase 2 trial) of doxazosin for migraine prophylaxis
- A tolerability and hypotension risk assessment in migraine patients, given the side-effect discontinuations in the early report
- Independent evidence for migraine with brainstem aura, if that subtype is to be pursued
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.