Nystatin

Evidence Level: L3

Predicted Indications: 10

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Table of Contents

1. Nystatin
2. Nystatin: From Candidiasis to Vulvovaginitis
   1. One-Sentence Summary
   2. Quick Overview
   3. Why is This Prediction Reasonable?
   4. Clinical Trial Evidence
   5. Literature Evidence
   6. UK Market Information
   7. Safety Considerations
   8. Conclusion and Next Steps
   9. Disclaimer

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## Pharmacist Assessment Report

Using no additional skill — this is a direct content-generation task against a fully specified template already in context.

Nystatin: From Candidiasis to Vulvovaginitis

One-Sentence Summary

Nystatin is a polyene antifungal historically used to treat candidiasis (oral, cutaneous and vaginal). The TxGNN model predicts it may be effective for vulvovaginitis, with 0 registered clinical trials but 20 supporting publications, including two cohort studies directly evaluating nystatin in vulvovaginal candidiasis. Note: the evidence itself suggests this is less a “new” repurposing than a re‑confirmation of nystatin’s existing antifungal role, since vulvovaginitis is most commonly caused by Candida albicans.

Quick Overview

Item	Content
Original Indication	Not formally recorded in this dataset (original_indications and original_moa are data gaps — DG002). Based on drug-class knowledge, nystatin is a polyene antifungal traditionally used for candidiasis.
Predicted New Indication	Vulvovaginitis
TxGNN Prediction Score	99.92%
Evidence Level	L3
UK Market Status	Not marketed
Number of Marketing Authorisations	0
Recommended Decision	Proceed with Guardrails

Why is This Prediction Reasonable?

Detailed mechanism of action data is flagged as a data gap in the underlying evidence pack (DG002). However, the model’s own repurposing rationale provides sufficient mechanistic detail to assess plausibility: nystatin is a polyene antifungal that binds ergosterol in the fungal cell membrane, forming pores that cause leakage of intracellular contents and fungal cell death.

Vulvovaginitis is most commonly caused by Candida albicans infection, and this pathogen-driven mechanism maps directly onto nystatin’s established antifungal action. The evidence pack itself notes that this prediction falls within nystatin’s existing core indication range rather than representing atypical drug repurposing — in other words, this is closer to confirming a known clinical use than discovering a genuinely novel one.

Two cohort studies in the literature evidence directly support this: one evaluating combined vaginal nystatin/nifuratel therapy for mixed vulvovaginitis, and another correlating in-vitro nystatin susceptibility with clinical outcomes in complicated vulvovaginal candidiasis. This gives the prediction a stronger empirical basis than a pure model-only inference.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
20406393	2011	Cohort	Mycoses	In-vitro fluconazole/nystatin susceptibility testing in 287 Candida isolates from complicated VVC, correlated with clinical treatment outcome
16047929	2005	Cohort	Ceska gynekologie	Evaluation of combined vaginal nifuratel + nystatin therapy for mixed/miscellaneous vulvovaginitis
39771534	2024	Review	Pharmaceutics	Update on management of fluconazole-resistant VVC; nystatin discussed alongside boric acid and newer agents (oteseconazole, ibrexafungerp)
21774671	2011	Review	J Womens Health	Review of boric acid for recurrent VVC, discussing nystatin as an alternative in azole-resistant non-albicans species
25775428	2015	Review	BMJ Clinical Evidence	General overview of vulvovaginal candidiasis; C. albicans accounts for 85–90% of cases
21718579	2010	Review	BMJ Clinical Evidence	General overview of vulvovaginal candidiasis epidemiology and treatment
19454049	2007	Review	BMJ Clinical Evidence	General overview of vulvovaginal candidiasis epidemiology and treatment
12228137	2002	Review	BMJ	Overview of vulvovaginal candidiasis diagnosis and management
4919155	1970	Review	Med Clin North Am	Historical review of nystatin pharmacology and clinical use
11363911	1996	Review	J Int Assoc Physicians AIDS Care	Review of candidiasis management

UK Market Information

Nystatin currently has no marketing authorisations recorded in this dataset (total_licenses: 0, licenses: []); UK market status is Not marketed.

Safety Considerations

Please refer to the SmPC and BNF for safety information. Report suspected adverse reactions via the Yellow Card Scheme.

(Note: key warnings, contraindications and DDI fields in this evidence pack are unpopulated/data-gap (DG001, Blocking severity) — MHRA label data would need to be sourced separately before any safety initial assessment can proceed.)

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: Two cohort studies plus a consistent body of review literature support nystatin’s mechanistic and clinical plausibility for vulvovaginitis, and the underlying rationale indicates this prediction largely reconfirms nystatin’s existing antifungal indication rather than a novel use — but there are no clinical trials, no UK marketing authorisation, and safety/label data are currently missing (Blocking gap DG001).

To proceed, the following is needed:

• MHRA-equivalent SmPC data (warnings, contraindications, DDI) — currently a Blocking data gap
• Confirmation of nystatin’s formally documented original indication(s) and MOA (currently a High-severity gap)
• Clarification of whether this represents genuine repurposing or simply an unlicensed-in-UK formulation of an already-established antifungal use
• A route-of-administration assessment (vaginal formulation availability), since route_compatibility data is currently unpopulated

  Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.

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