TOL-463

TOL-463, also known as boric acid/ethylenediaminetetraacetic acid or boric acid/EDTA, is an <a href="/facts/Anti-infective/182XrncP">anti-infective</a> medication which is under development for the treatment of <a href="/facts/Bacterial_vaginosis/Tmvw2bMR">bacterial vaginosis</a> (BV) and <a href="/facts/Vulvovaginal_candidiasis/vcrTlo0C">vulvovaginal candidiasis</a> (VVC) (vaginal yeast infection). It is a <a href="/facts/Boric_acid_(vaginal)/Wj2ygPwQ">boric acid</a>-based <a href="/facts/Vaginal_administration/kIwGRMDf">vaginal</a> anti-infective enhanced with <a href="/facts/Ethylenediaminetetraacetic_acid/XvHgKQyD">ethylenediaminetetraacetic acid</a> (EDTA) which was designed to have improved activity against <a href="/facts/Vaginal/ca5jsTwF">vaginal</a> <a href="/facts/Bacterial/wC8xSCsU">bacterial</a> and <a href="/facts/Fungal/BHo5DP59">fungal</a> <a href="/facts/Biofilm/zg93x2w4">biofilms</a> while sparing protective <a href="/facts/Lactobacilli/uKhIxU67">lactobacilli</a>. EDTA enhances the antimicrobial activity of boric acid and improves its efficacy against relevant biofilms.
In a small <a href="/facts/Phases_of_clinical_research/o8hEodVu">phase 2</a> <a href="/facts/Randomized_controlled_trial/LG9lkyVx">randomized controlled trial</a>, TOL-463 as an <a href="/facts/Vaginal_insert/kIwGRMDf">insert</a> or <a href="/facts/Vaginal_gel/alFfLndS">gel</a> achieved clinical cure rates of 50 to 59% against BV and 81 to 92% against VVC in women who had one or both conditions. It was effective and safe in the study, though it was without indication of superiority over other <a href="/facts/Antifungal/WEk5nS2B">antifungal</a> medications for VVC. The cure rates against BV with TOL-463 were said to be comparable to those with recently approved antibiotic treatments like single-dose <a href="/facts/Oral_administration/vNQcvLVx">oral</a> <a href="/facts/Secnidazole/ey98M9wa">secnidazole</a> (58%) and single-dose metronidazole vaginal gel (41%).
As of July 2022, TOL-463 is in <a href="/facts/Phases_of_clinical_research/o8hEodVu">phase 2</a> <a href="/facts/Clinical_trial/q8LMr832">clinical trials</a> for the treatment of BV and VVC. It was originated by Toltec Pharmaceuticals and is under development by Toltec Pharmaceuticals and the <a href="/facts/National_Institute_of_Allergy_and_Infectious_Diseases/PD8bQnvS">National Institute of Allergy and Infectious Diseases</a>. There have been no developmental updates since May 2019.

TOL-463 open-in-new

TOL-463