TOL-463 is an anti-infective medication which is under development for the treatment of bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) (vaginal yeast infection).[3][1][4][2] It is a boric acid-based vaginal anti-infective enhanced with ethylenediaminetetraacetic acid (EDTA) which was designed to have improved activity against vaginal bacterial and fungal biofilms while sparing protective lactobacilli.[1][2][4] EDTA enhances the antimicrobial activity of boric acid and improves its efficacy against relevant biofilms.[1]
 | |
 Boric acid (top) and EDTA (bottom) | |
| Combination of | |
|---|---|
| Boric acid | Antiseptic, antifungal |
| EDTA | Antimicrobial enhancer |
| Clinical data | |
| Other names | Boric acid/ethylenediamine-tetraacetic acid; Boric acid/EDTA |
| Routes of administration | Vaginal (insert, gel)[1][2] |
In a small phase 2 randomized controlled trial, TOL-463 as an insert or gel achieved clinical cure rates of 50 to 59% against BV and 81 to 92% against VVC in women who had one or both conditions.[4][2][1] It was effective and safe in the study, though it was without indication of superiority over other antifungal medications for VVC.[2][1] The cure rates against BV with TOL-463 were said to be comparable to those with recently approved antibiotic treatments like single-dose oral secnidazole (58%) and single-dose metronidazole vaginal gel (41%).[1]
As of July 2022, TOL-463 is in phase 2 clinical trials for the treatment of BV and VVC.[3] It was originated by Toltec Pharmaceuticals and is under development by Toltec Pharmaceuticals and the National Institute of Allergy and Infectious Diseases.[3] There have been no developmental updates since May 2019.[3]
See also
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External links
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