NDAORALSUSPENSION
Approved
Apr 1971
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
NILSTAT (nystatin) by Molecular Devices is clinical pharmacology nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. First approved in 1971.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NILSTAT (nystatin) is an oral polyene antifungal suspension approved in 1971 that binds to fungal cell membrane sterols, disrupting membrane permeability and causing leakage of intracellular components. It is used to treat candida and other fungal infections but is absorbed minimally following oral administration with no detectable blood levels at recommended doses.
LOE Approaching
With LOE approaching and moderate competitive pressure (30%), team size and investment are likely stabilizing or declining, creating defensive rather than growth-oriented opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is absorbed very sparingly following oral administration, with no detectable blood levels when given…
Pharmacologic Class:
Polyene Antifungal
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis
Started Jun 2011
221 enrolled
HIV-1 Infection
A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
Started Dec 2007
160 enrolled
VaginitisInfectious Vaginosis
A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
Candidiasis, OralHIV Infections
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Candidiasis, OralHIV Infections
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Candidiasis, OralHIV Infections
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.