Nicotine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Nicotine: Repurposing Prediction for Exercise-Induced Malignant Hyperthermia
One-Sentence Summary
The registration data supplied for nicotine do not state an original indication. The TxGNN model predicts it may be relevant to exercise-induced malignant hyperthermia, but this is a model prediction only, with 0 clinical trials and 0 publications supporting it. The mechanistic reasoning also suggests possible harm rather than benefit.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Exercise-induced malignant hyperthermia |
| TxGNN Prediction Score | 83.91% (model rank 49,771) |
| Evidence Level | L5 (model prediction only) |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 3 (two distinct registration numbers; H2466 is listed twice) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for this record. Nicotine is a nicotinic acetylcholine receptor agonist, and these receptors are present at the neuromuscular junction. That is the only plausible link to a skeletal muscle disorder such as exercise-induced malignant hyperthermia.
The link is weak, and it may point the wrong way. Nicotine acts as a depolarising agonist at the neuromuscular junction, so it could worsen a disorder of muscle calcium handling rather than treat it. No trial or publication supports the prediction. The high score alone is not enough to justify further work.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
| Registration Number | Product Name | Dosage Form |
|---|---|---|
| A/21.8.1/743 | Menoflush | Tablet |
| H2466 | Complenatal Ff | Capsule |
Both products are oral. No approved indication text or manufacturer is recorded for either. Menoflush and Complenatal FF appear to be multi-ingredient supplement-type products. The nicotine mapping for these registrations should be checked, because they may reflect a related compound such as nicotinamide rather than nicotine itself.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
No drug interactions were found in the queried data (0 records).
Conclusion and Next Steps
Decision: Hold
Rationale: This is a prediction without any supporting trial or literature (L5). The plausible mechanism suggests nicotine could aggravate, not relieve, the condition. Safety data are also missing, which blocks progression to safety screening.
To proceed, the following is needed:
- The SAHPRA package insert, including warnings and contraindications (a blocking gap)
- Mechanism of action data, for example from DrugBank
- Confirmation that the three SAHPRA registrations actually contain nicotine
- A mechanistic and safety review of nicotine in malignant hyperthermia, before any further work
Other predictions for the same drug: Blepharospasm has the strongest evidence of the ten predicted indications (L3). It rests on two small pilot studies, and the 1998 follow-up found nicotine nasal spray not to be a reliable treatment (PMID 9452355). Migraine disorder, oppositional defiant disorder and developmental disorder of mental health have only indirect, mostly harm-related evidence (L4). The remaining predictions are L5. All were rated Hold.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.