KLAYESTA (nystatin) · EPIC PHARMA LLC
KLAYESTA is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
Details
- Status
- Prescription
- First Approved
- 2018-04-30
- Routes
- TOPICAL
- Dosage Forms
- POWDER
KLAYESTA Approval History
What KLAYESTA Treats
1 indicationsKLAYESTA is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidiasis
KLAYESTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03178149 | 7317-CL-0003 | Ph 1 | recruiting | A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration |
| NCT04550546 | STUDY00004638 | Ph 1 | completed | Effects of Nystatin Suspension Oral Application on Oral Microbial Community |
| NCT04532060 | FoAr | Ph 2 | completed | Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis |
| NCT03862079 | 2017-0466 NCI-2019-01045, 2017-0466 | Ph 2 | withdrawn | Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics |
| NCT01495039 | Nista 1 | Ph 4 | completed | Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients |
| NCT01531192 | ZTB630301 | Ph 4 | completed | Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KLAYESTA FDA Label Details
Indications & Usage
KLAYESTA is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. KLAYESTA is not indicated for systemic, oral, intravaginal or ophthalmic use.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.