Cyclandelate

Evidence Level: L5 Predicted Indications: 9

Table of Contents

  1. Cyclandelate
    1. Pharmacist Assessment Report
    2. Cyclandelate: Prinzmetal angina
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. India Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Cyclandelate: Prinzmetal angina

One-Sentence Summary

Cyclandelate is a direct-acting smooth muscle relaxant and vasodilator that is currently marketed in India. The TxGNN model predicts it may be useful for Prinzmetal angina, with a score of 0.9980. No clinical trials or publications directly studying this use were found, so the evidence rests on the model prediction and a mechanistic rationale.

Quick Overview

Item Content
Original Indication Not recorded in the local data
Predicted New Indication Prinzmetal angina
TxGNN Prediction Score 0.9980
Evidence Level L5
India Market Status Listed in a compiled Indian medicine price dataset (9 of 9) – CDSCO approval status is not included in this data
Number of Listed Products 9 (valid: 9)
Recommended Decision Hold

Why is This Prediction Reasonable?

Cyclandelate relaxes vascular smooth muscle directly. It is also reported to have calcium-antagonist-like activity. Detailed mechanism-of-action data are not available in the compiled data, so this description comes from general pharmacological knowledge.

Vasospasm of the coronary arteries is the core pathophysiology of Prinzmetal angina. Drugs that relax vascular smooth muscle and limit calcium-driven contraction are therefore mechanistically plausible candidates. Calcium-channel blockers are a recognised treatment approach for this condition.

This remains a hypothesis. The high model score is a computational prediction. No trials or publications that directly study cyclandelate in Prinzmetal angina were provided, so the efficacy and dose in this condition are unknown.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

India Market Information

Cyclandelate is marketed in India. All 9 licences are valid single-ingredient products. The main authorisations are listed below.

Authorization Number Product Name Dosage Form Approved Indication
50613 Cevadil 200mg Capsule Strip of 10 capsules Not stated
45032 CYCLASYN 400MG Tablet Strip of 10 tablets Not stated
36220 Cyclo 200mg Tablet Strip of 10 tablets Not stated
49224 Cevadil 400mg Capsule Strip of 10 capsules Not stated
238002 VASODAL 200MG Capsule Strip of 10 capsules Not stated

Safety Considerations

  • Drug Interactions: 17 interacting drugs were identified, all rated Moderate. Examples:
    • SGLT2 inhibitors: canagliflozin, dapagliflozin, empagliflozin, ertugliflozin
    • Prostacyclin-pathway agents: selexipag, treprostinil, epoprostenol, iloprost
    • Other agents: pentoxifylline, promethazine, amifostine, ozanimod, procarbazine, topical minoxidil, brimonidine (ophthalmic and topical), nitrous acid

    Several of these have blood-pressure-lowering or vasodilatory effects, so additive hypotension should be considered.

For warnings and contraindications, please refer to the package insert.

Conclusion and Next Steps

Decision: Hold

Rationale: The mechanistic rationale is reasonable, because coronary vasospasm is the core problem in Prinzmetal angina and cyclandelate relaxes vascular smooth muscle. However, there are no clinical trials or publications directly studying this use, so the evidence level is L5 and the prediction rests on the model score alone.

To proceed, the following is needed:

  • A systematic search for clinical or observational studies of cyclandelate in Prinzmetal angina
  • Confirmed mechanism-of-action data, particularly on calcium-channel activity in coronary vessels
  • Package insert warnings and contraindications, to complete the safety review, especially for patients with low blood pressure or taking other vasodilators
  • A dose and formulation assessment against the existing marketed oral capsules and tablets
  • If early evidence is supportive, a small proof-of-concept study with careful blood-pressure monitoring

Disclaimer

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