Chemistry:TOL-463
 | |
 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] |
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] In a small phase 2 randomized controlled trial, TOL-463 as an insert or gel achieved clinical cure rates of 50–59% against BV and 81–92% 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 May 2019, 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]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Safety and Efficacy of a Novel Vaginal Anti-infective, TOL-463, in the Treatment of Bacterial Vaginosis and Vulvovaginal Candidiasis: A Randomized, Single-blind, Phase 2, Controlled Trial". Clin Infect Dis 68 (5): 803–809. February 2019. doi:10.1093/cid/ciy554. PMID 30184181.
- ↑ 2.0 2.1 2.2 2.3 2.4 "Vulvovaginal Candidiasis: A Review of the Evidence for the 2021 Centers for Disease Control and Prevention of Sexually Transmitted Infections Treatment Guidelines". Clin Infect Dis 74 (Suppl_2): S162–S168. April 2022. doi:10.1093/cid/ciab1057. PMID 35416967.
- ↑ 3.0 3.1 3.2 "TOL 463 - AdisInsight". https://adisinsight.springer.com/drugs/800047491.
- ↑ 4.0 4.1 4.2 "Current and emerging pharmacotherapy for recurrent bacterial vaginosis". Expert Opin Pharmacother 22 (12): 1593–1600. August 2021. doi:10.1080/14656566.2021.1904890. PMID 33750246.
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