Natamycin
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
Natamycin: Vulvitis
One-Sentence Summary
Natamycin is a polyene antifungal that is marketed in India as single-ingredient ophthalmic products. The TxGNN model predicts it may be useful for vulvitis, with a score of 0.9981. The supporting evidence is 1 completed Phase 3 trial and several publications on vaginal natamycin, and none of them studies vulvitis as its own endpoint.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Vulvitis |
| TxGNN Prediction Score | 0.9981 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. In general, natamycin is a polyene antifungal. Drugs of this class bind fungal membrane sterols and disrupt the fungal cell membrane. Natamycin is used topically.
The prediction is plausible only for vulvitis with a fungal (yeast) cause, where the drug’s antifungal activity would be relevant. Non-infectious vulvitis, for example from irritants, allergy or dermatological disease, would not be expected to respond. The vaginal-route studies listed below show that natamycin has been used on genital mucosa. They do not test vulvitis directly.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT06411314 | Phase 3 | Completed | 218 | International randomized superiority trial of natamycin 100 mg + lactulose 300 mg vaginal suppositories versus natamycin 100 mg suppositories alone or lactulose 300 mg alone in non-pregnant adult women. It assessed efficacy and safety. Vulvitis was not a separate primary endpoint, so the relevance is indirect. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39979898 | 2025 | RCT | BMC Women’s Health | Report of the randomized trial of natamycin + lactulose vaginal suppositories (100 mg + 300 mg) in adult females, assessing efficacy and safety. |
| 6760652 | 1982 | Clinical study | Acta Obstet Gynecol Scand | 33 women used natamycin vaginal tablets for 10 days, and partners were treated double-blind with natamycin cream or placebo. Cure rates were 94% with active partner treatment and 88% with placebo, not significantly different. |
| 6966774 | 1980 | Clinical study | N Z Med J | 50 women received natamycin vaginal tablets twice nightly for 10 days. The cure rate was 76% at two weeks and was maintained at four weeks. |
| 1082689 | 1975 | Clinical study (combination) | Zentralbl Gynakol | Oral metronidazole plus vaginal natamycin tablets was used for genital infections. Any benefit cannot be attributed to natamycin alone. |
| 6332983 | 1984 | Clinical study | Mykosen | Dose-related effects of a newly developed natamycin suppository formulation. |
| 18288724 | 2008 | Formulation study | J Pharm Sci | A natamycin:gamma-cyclodextrin complex was prepared for vaginal mucoadhesive tablets. It improved solubility and stability, and in-vitro antifungal activity was preserved (MIC90 below 0.0313 µg/mL). |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 153940 | Natray Eye Drop | Bottle of 3 ml ophthalmic suspension | Not stated |
| 160579 | Natcon Eye Drop | Packet of 3 ml eye drop | Not stated |
| 80292 | Elmycin Eye Drop | Packet of 3 ml eye drop | Not stated |
| 247165 | Zonat Eye Drop | Packet of 5 ml eye drop | Not stated |
| 154732 | Ntc Eye Drop | Bottle of 5 ml ophthalmic suspension | Not stated |
These are 5 of 20 valid single-ingredient licences in the local data, and the list may be partial. All records are ophthalmic products, and no vaginal or vulvar product appears among them.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: No study cited here examines vulvitis itself, so the evidence level is L5 despite the high model score. The only Phase 3 trial is indirect, because vulvitis was not a separate endpoint. Benefit is plausible only if the vulvitis is fungal in origin.
To proceed, the following is needed:
- A study that defines and measures vulvitis as its own endpoint, with fungal and non-fungal causes separated.
- Mechanism-of-action data and package-insert safety information.
- Confirmation of a suitable vulvar or vaginal formulation, since the locally licensed products are ophthalmic.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.