Nystatin
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
Nystatin: From Topical Antifungal Use to Vulvovaginitis
One-Sentence Summary
Nystatin is a polyene antifungal marketed in South Africa in topical and vaginal products, but the supplied data does not record its original approved indication. The TxGNN model predicts it may be effective for vulvovaginitis, and 19 publications support this. There are no registered clinical trials for this indication. This is probably an established use rather than true repurposing, so it should be confirmed against the SAHPRA label.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the supplied registration data |
| Predicted New Indication | Vulvovaginitis |
| TxGNN Prediction Score | 99.92% |
| Evidence Level | L3 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 4 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Nystatin binds ergosterol in the fungal cell membrane and forms pores. This causes leakage of cell contents and fungal cell death. Formal mechanism-of-action data was not available from DrugBank, so this description comes from the general pharmacology of polyene antifungals.
Candida albicans causes about 85–90% of vulvovaginal candidiasis cases, according to the BMJ Clinical Evidence reviews. Nystatin’s ergosterol-targeting action is directly relevant to this organism. Nystatin has been used for vulvovaginal candidiasis since the 1950s, although azoles have since become the usual first choice (1992 review).
The prediction is therefore mechanistically sound. It is better described as a confirmation of established use than a new discovery.
Clinical Trial Evidence
Currently no related clinical trials registered for vulvovaginitis.
Literature Evidence
No randomised controlled trial was identified from the titles and abstracts. The table lists the most relevant items, with the strongest study types first.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 20406393 | 2011 | Cohort | Mycoses | Compared fluconazole and nystatin susceptibility with clinical outcome in 283 patients with complicated vulvovaginal candidosis. Fluconazole resistance was 0.8% and susceptible-dose-dependent 5.3% of 132 isolates. |
| 21918792 | 2012 | Clinical study | Acta Derm Venereol | Compared fluconazole and nystatin for vaginal Candida in Brazilian women (932 screened, 114 positive for yeasts). |
| 31969236 | 2019 | Clinical study | Acta Dermatovenerol Croat | GENIE study of oxytetracycline plus nystatin vaginal tablets in 189 women with non-specific or mixed vulvovaginal infections. Beneficial effects were reported in 100% of participants. |
| 4584828 | 1973 | Trial (design unclear) | J Obstet Gynaecol Br Commonw | Clotrimazole versus nystatin in vaginal moniliasis. No abstract is available. |
| 16047929 | 2005 | Clinical study | Ceska Gynekol | Mixed vulvovaginal infections treated with combined nifuratel and nystatin vaginal products. |
| 39771534 | 2024 | Review | Pharmaceutics | Update on fluconazole-resistant vulvovaginal candidiasis. Nystatin is among the alternatives discussed, with boric acid, oteseconazole and ibrexafungerp. |
| 25775428 | 2015 | Review | BMJ Clin Evid | Evidence review of vulvovaginal candidiasis treatment. Earlier editions are also retrieved (2010, 2007). |
| 1436934 | 1992 | Review | Obstet Gynecol Clin North Am | Topical antifungals. Nystatin has been surpassed by imidazoles and triazoles as first choice. |
| 30359236 | 2018 | Animal study | BMC Microbiol | In a rat model of vulvovaginal candidiasis, nystatin enhanced the immune response against C. albicans and protected the vaginal epithelium ultrastructure. |
| 32104010 | 2020 | Laboratory study | Infect Drug Resist | ZnO nanoparticles and nystatin against fluconazole-resistant C. albicans isolates from vulvovaginal candidiasis. |
South Africa Market Information
Approved indication text and manufacturer names were not included in the supplied registration data.
| Registration Number | Product Name | Dosage Form |
|---|---|---|
| L/20.1.6/0394 | Nystacid | Ointment |
| 50/20.1.1/0250 | Polygynax® | Pvc |
| G1591 | Kenacomb | Cream |
| G1592 | Kenacomb | Ointment |
The dosage form recorded for Polygynax® is “Pvc”. Please verify the exact form and active ingredients on the SAHPRA label. Essential Medicines List (EML) status was not supplied.
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: Proceed with Guardrails
Rationale:
- Nystatin’s mechanism fits Candida-driven vulvovaginitis, and the literature (reviews, a cohort study and several clinical studies) supports its use.
- Evidence is graded L3 because no registered trials or randomised controlled trials were identified.
To proceed, the following is needed:
- The SAHPRA package insert warnings and contraindications. This is a blocking gap for safety screening.
- Confirmation of whether vulvovaginitis is already an approved indication on the local labels.
- Formal mechanism-of-action data from DrugBank.
- Confirmation of route compatibility, since the registered forms are an ointment, a cream and “Pvc”.
Other predictions in the pack:
- Vulvitis is a research question at L4. Its literature overlaps with the vulvovaginitis evidence and is not independent.
- Orbital disease, cystic teratoma, spinal cord dermoid cyst, atrophic vaginitis, biotin metabolic disease, commissural lip fistula and osteoradionecrosis of the mandible are on Hold at L5. They rest on model prediction alone, with no plausible mechanism or supporting studies.
This report is for research reference only and is not medical advice. Predicted 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.