Acetazolamide
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Acetazolamide
- Acetazolamide: From Carbonic Anhydrase Inhibitor to Exercise-Induced Malignant Hyperthermia
Acetazolamide: From Carbonic Anhydrase Inhibitor to Exercise-Induced Malignant Hyperthermia
One-Sentence Summary
Acetazolamide is a marketed carbonic anhydrase inhibitor. Its original approved indication text is not available in the provided data. The TxGNN model predicts it may be effective for exercise-induced malignant hyperthermia, with a very high score. This prediction has no clinical trials and no publications behind it, so it rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Exercise-induced malignant hyperthermia |
| TxGNN Prediction Score | 99.95% |
| Evidence Level | L5 (model prediction only) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 (the five listed below are all ANDAs) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the record. Acetazolamide is known to inhibit carbonic anhydrase. It has also been used in periodic paralysis and other channelopathies.
That use suggests a possible link to pH and ion handling in muscle, which could relate to exercise-induced malignant hyperthermia. This link is speculative. No trial or publication was retrieved to support it, and the score alone does not show that the drug works for this condition.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
The drug is also sold as a lyophilized powder for injection, an extended-release capsule, and a capsule, in addition to the tablet.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA210588 | Acetazolamide | Tablet | ANI Pharmaceuticals, Inc. |
| ANDA211372 | Acetazolamide | Tablet | TRUPHARMA, LLC |
| ANDA205530 | Acetazolamide | Tablet | AvKARE |
| ANDA040904 | Acetazolamide | Capsule, extended release | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
| ANDA209734 | Acetazolamide | Tablet | Strides Pharma Science Limited |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is model-only (L5) with no registered trials or publications, and the proposed mechanism is speculative. The drug is widely marketed in the US, but that does not support this new indication.
To proceed, the following is needed:
- Package insert warnings and contraindications, which are missing and block safety screening
- Detailed mechanism of action data
- Any preclinical or clinical evidence linking acetazolamide to exercise-induced malignant hyperthermia
- Consider other predictions first. In the same Evidence Pack, cardiomyopathy (rank 7) has the most support: three recruiting acetazolamide-related heart failure trials (NCT05802849, NCT06092437, NCT06166654). That link is indirect and at heart-failure level, so it is only a research question.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.