Clinical Trials

Tavaborole (AN-2690) has been evaluated in several clinical trials sponsored by Pfizer, all of which have completed recruitment for the treatment of fungal nail infections, including onychomycosis and tinea unguium. Spanning Phase 2 and Phase 4 development, these studies investigated the safety, tolerability, absorption, and pharmacokinetic profile of topical applications in adult patients.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03405818 Completed
Onychomycosis|Tinea Unguium
Pfizer
 2015-10-22 Phase 4
NCT00679601 Completed
Onychomycosis
Pfizer
 2007-03-31 Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Tavaborole (AN-2690) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tavaborole is a boron-containing antifungal agent that selectively binds to and inhibits fungal leucyl-tRNA synthetase, thereby blocking essential protein translation by preventing leucine charging of transfer RNA. This disruption of fungal cellular protein synthesis halts fungal cell growth and replication, providing therapeutic activity against fungal pathogens in conditions such as onychomycosis.

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>).

Jump to

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