Drug intelligence / Profile preview

TOL-463

Development stage
Phase 2
Lead developer
Toltec Pharmaceuticals
Modality
Small Molecules
Administration
Vaginal
01

Overview

TOL-463 is an investigational vaginal insert containing a combination of boric acid and ethylenediaminetetraacetic acid (EDTA). Developed by Toltec Pharmaceuticals, it is intended for the treatment and suppression of recurrent bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC). The mechanism of action involves the antimicrobial properties of boric acid and the biofilm-disrupting activity of EDTA. EDTA acts as a chelating agent that destabilizes the protective biofilm matrix produced by pathogens such as *Gardnerella vaginalis*, thereby enhancing the clearance of the infection and preventing recurrence. TOL-463 has been studied in Phase II clinical trials, including the NIAID-sponsored SUBVert trial, as a maintenance therapy following induction with standard antibiotics.

Other names
boric acid/ethylenediaminetetraacetic acidboric acid/EDTA
02

Targets

Vaginal polymicrobial biofilm

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