Mebendazole
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Mebendazole: From Anthelmintic Use to Acne
One-Sentence Summary
Mebendazole is an oral anthelmintic (anti-worm) medicine. The TxGNN model predicts it may be effective for acne, with a very high score of 99.2%. However, there are 0 clinical trials and 1 publication (an unrelated case report), so the prediction rests on the model alone and has no supporting evidence.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA data supplied (mebendazole is an anthelmintic) |
| Predicted New Indication | Acne |
| TxGNN Prediction Score | 99.20% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 2 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Mebendazole is a benzimidazole anthelmintic that works by inhibiting tubulin in parasites. This is the basis for its use against worm infections.
Acne is a chronic inflammatory condition of the hair follicle and sebaceous gland. It involves excess sebum, follicular blockage, Cutibacterium acnes and inflammation. Inhibition of parasite tubulin has no established link to any of these processes, so we found no credible mechanistic link.
The high TxGNN score (0.992) is a graph-based prediction only. It should not be read as evidence of clinical benefit.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 7072899 | 1982 | Case report | Am J Trop Med Hyg | Case of proliferative sparganosis (a tapeworm larval infection) in Venezuela. The patient had acne-like skin lesions as part of the infection. It does not study acne vulgaris or mebendazole treatment. |
This is the only publication linked to this prediction. It does not support the acne indication.
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 32/12/0538 | Cipex | Tablet | — |
| Reg. No. 27/12/0082 | Adco-wormex | Tablet | — |
Both products are oral tablets. The approved indication text was not included in the data supplied, so it should be checked against the current Professional Information (PI).
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: The acne prediction is L5 (model prediction only). There are no trials, no relevant literature and no plausible mechanism. Safety data were also not available in the pack.
Other predicted indications in the pack: Acne is the top-ranked prediction, but it is not the best supported. Of the 10 predictions, the alveolar echinococcosis and Echinococcus granulosus infection predictions are the most credible. Both are parasitic diseases in which benzimidazoles already play a recognised role.
| Predicted Indication | TxGNN Score | Evidence Level | Suggested Decision |
|---|---|---|---|
| Alveolar echinococcosis | 94.20% | L3 | Proceed with Guardrails |
| Echinococcus granulosus infection | 95.61% | L3 | Research Question |
- Alveolar echinococcosis: there is one completed observational study, NCT02876146 (50 patients, albendazole follow-up markers). There are also multiple reviews and a comparative study of mebendazole and albendazole. No RCT is available, and the effect of mebendazole is not separated from albendazole.
- Guardrails for alveolar echinococcosis: specialist-directed use, therapeutic drug monitoring, liver and blood count monitoring, and long-term follow-up.
- Cystic echinococcosis (E. granulosus): a 1989 series of 70 patients treated with mebendazole supports the prediction, but no RCT is available.
- Leishmaniasis (diffuse cutaneous) and Demodex infestation: only a class-level antiparasitic rationale exists, with no supporting studies.
- Hordeolum, impetigo, botulism (both forms) and Sorsby’s fundus dystrophy: no plausible mechanism.
To proceed, the following is needed:
- SAHPRA package insert warnings and contraindications, which block any safety screening (data gap DG001)
- Mechanism of action data from DrugBank (data gap DG002)
- The approved indication text for both registrations
- For the echinococcosis candidates: mebendazole-specific comparative data and a review of local specialist practice
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.