Ivermectin
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Ivermectin: From Antiparasitic Use to Vulvovaginal Candidiasis
One-Sentence Summary
Ivermectin is a marketed antiparasitic drug with oral, cream and lotion products in the US. The TxGNN model predicts it may be effective for vulvovaginal candidiasis, but 0 clinical trials and 0 publications currently support this prediction. It is a model-only signal with no supporting evidence.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not listed in the license data (ivermectin is known as an antiparasitic, e.g., for strongyloidiasis and scabies) |
| Predicted New Indication | Vulvovaginal candidiasis |
| TxGNN Prediction Score | 99.95% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Ivermectin’s known action is on glutamate-gated chloride channels in invertebrates, which explains its antiparasitic use. It has no established clinical antifungal activity.
Vulvovaginal candidiasis is a fungal infection, while ivermectin’s proven uses are against parasites. No mechanistic link between the two has been established. The very high score (0.999) most likely reflects proximity in the knowledge graph, such as similarity to other anti-infective drugs, rather than biological or clinical support.
Several other predictions for this drug are also Candida-related or vaginal conditions (esophageal, neonatal, congenital and invasive candidiasis, vulvovaginitis). All are L5 with no supporting trials. The two papers linked to these related predictions describe strongyloidiasis and crusted scabies, which are antiparasitic uses. Candidiasis appears in them only as a background condition, so they do not support an antifungal role.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ANDA204154 | Ivermectin (Edenbridge Pharmaceuticals) | Tablet | Not listed |
| ANDA210019 | Ivermectin (Bryant Ranch Prepack) | Cream | Not listed |
| M031 | Ivometn ivermectin lice treatment (Shenzhen Zhenshangzekai Technology) | Lotion | Not listed |
| M031 | Lice treatment dedicated (Shenzhen Zhenshangzekai Technology) | Lotion | Not listed |
| NDA206255 | Ivermectin (Mayne Pharma) | Cream | Not listed |
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found in the queried source.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a knowledge-graph score. There are no clinical trials or publications, and no antifungal mechanism is established. Effective standard antifungal therapies already exist for candidiasis, so this candidate does not justify progression without new evidence.
To proceed, the following is needed:
- Mechanism of action data and any in vitro evidence of activity against Candida species
- Package insert warnings and contraindications (a blocking gap for safety screening)
- Preclinical or early clinical data for a vaginal or topical route, since route compatibility has not been assessed
- Confirmation of the approved indications for the listed US products
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.