Clinical Trials

Multiple clinical trials spanning Phase 1 to Phase 3 evaluate mono- and combination antimicrobial regimens of natamycin for ophthalmic and gynecologic conditions, including fungal keratitis, mycotic corneal ulcers, ocular fungal infections, and vulvovaginal candidiasis. With recruitment statuses ranging from completed and recruiting to terminated, these studies are sponsored by pharmaceutical entities such as Avva Rus, JSC as well as academic and research institutions including the University of California San Francisco, L.V. Prasad Eye Institute, and the National Eye Institute.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06658002 RECRUITING
Fungal Keratitis; Corneal Ulcer
University of California, San Francisco
 2025-09-01 PHASE3
NCT05110001 COMPLETED
Acanthamoeba Keratitis; Fungal Keratitis
University of California, San Francisco
 2022-08-03 PHASE3
NCT06411314 COMPLETED
Vulvovaginal Candidiasis, Genital
Avva Rus, JSC
 2022-12-29 PHASE3
NCT02731638 COMPLETED
Corneal Ulcer; Fungal Keratitis
University of California, San Francisco
 2016-09 PHASE3
NCT03230058 UNKNOWN
Infection, Fungal
L.V. Prasad Eye Institute
 2017-01-01 PHASE2; PHASE3
NCT00996736 COMPLETED
Corneal Ulcer; Eye Infections, Fungal
University of California, San Francisco
 2010-04 PHASE3
NCT00516399 TERMINATED
Fungal Keratitis
University of California, Los Angeles
 2008-03 PHASE3
NCT00997035 Completed
Corneal Ulcer|Eye Infections Fungal
University of California San Francisco|Aravind Eye Hospitals India|Dartmouth-Hitchcock Medical Center|Lumbini Eye Institute and Hospital|Bharatpur Eye Hospital|National Eye Institute (NEI)
 2010-05 Phase 3
NCT00557362 COMPLETED
Fungal Keratitis
University of California, San Francisco
 2007-11 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-05)

Check the Natamycin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Natamycin acts as a macrolide polyene antifungal by binding specifically to ergosterol within fungal cell membranes, thereby inhibiting ergosterol-dependent transport proteins and blocking essential membrane fusion and fission processes. This disruption of critical membrane functions inhibits fungal cell growth and triggers cell death, rendering natamycin therapeutically effective in treating fungal keratitis and corneal ulcers.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.