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Mycostatin (nystatin)
Nystatin (Mycostatin) is a generic polyene antifungal marketed for cutaneous or mucocutaneous mycotic infections, originally developed by Squibb. Its key strength lies in its mechanism of action, which involves binding ergosterol in fungal cell membranes to create pores leading to cell death, and it is not absorbed systemically, minimizing systemic side effects. The primary risk is the key composition patent expiry in 2028, which could increase competition from other generics.
At a glance
| Generic name | nystatin |
|---|---|
| Also known as | Mycostatin, Nystop, Bio-Statin |
| Sponsor | Generic (originally Squibb) |
| Drug class | Polyene Antifungal [EPC] |
| Target | Ergosterol (fungal cell membrane) |
| Modality | Small molecule (natural product) |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1954-01-01 (United States) |
Approved indications
- Cutaneous or Mucocutaneous Mycotic Infections
Common side effects
- Diarrhea
- Vomiting
- Polydipsia
- Polyuria
- SAP enzyme elevation
- SGPT (ALT) enzyme elevation
Serious adverse events
- Cushing's syndrome
- Hearing loss
- Bloody diarrhea
Key clinical trials
- Single Blind Randomized Study of Efficacy and Safety of Vaginal Cream With Association of Metronidazole, Nystatin and Dexamethasone in the Treatment of Bacterial and Fungal Vaginal Infections (Phase 3)
- Antifungal Potential of Moringa Olifera-loaded Nanoparticles Against Otomycosis; Preparation, Characterization, and Clinical Evaluation (EARLY/Phase 1)
- RGNOSIS: Ecological Effects of Decolonisation Strategies in Intensive Care (Phase 3)
- Comparison of Therapeutic Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis (Phase 2)
- A Phase III Study of Magic Mouthwash Plus Sucralfate Versus Benzydamine HCl for Treatment of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients. (Phase 3)
- A Phase 1/2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Non-muscle Invasive Bladder (Phase 1)
- The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer (Phase 2)
- Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mycostatin CI brief — competitive landscape report
- Mycostatin updates RSS · CI watch RSS
- Generic (originally Squibb) portfolio CI