TOL-463 / Toltec Pharma - LARVOL DELTA

Treatment of Vulvovaginal Candidiasis-An Overview of Guidelines and the Latest Treatment Methods. (PubMed, J Clin Med) - "The efficacy of probiotics and substances such as TOL-463 and chlorhexidine is indicated as satisfactory; however, there are no relevant guidelines...Another clinical problem is the treatment of VVC with azole intolerance or resistance, for which literature proposes the use of several drugs including oteseconazole, ibrexafungerp, and voriconazole...Thus far, few precise recommendations are available in the literature. Future studies should focus on atypical VVC forms to elucidate the inconsistent findings."

Journal • Review • Candidiasis • Dermatology • Vaginitis

Vulvovaginal Candidiasis: A Review of the Evidence for the 2021 Centers for Disease Control and Prevention of Sexually Transmitted Infections Treatment Guidelines. (PubMed, Clin Infect Dis) - "There has been significant new knowledge generated about VVC since the 2015 CDC Guidelines which have led to changing recommendations."

Journal • Review • Candidiasis • Human Immunodeficiency Virus • Infectious Disease • Vaginitis • CD4

Suppression Of Bacterial Vaginosis (BV) [SUBVert] (clinicaltrials.gov) - P2 | N=82 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Completed | N=250 ➔ 82 | Trial completion date: Sep 2022 ➔ Feb 2022 | Trial primary completion date: Sep 2022 ➔ Dec 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Vaginitis

Suppression Of Bacterial Vaginosis (BV) [SUBVert] (clinicaltrials.gov) - P2; N=250; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Trial completion date: Sep 2021 ➔ Sep 2022; Trial primary completion date: Sep 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Vaginitis

Suppression Of Bacterial Vaginosis (BV) [SUBVert] (clinicaltrials.gov) - P2; N=250; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Trial completion date: Jul 2020 ➔ Jul 2021; Trial primary completion date: Jul 2020 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date

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. (PubMed, Clin Infect Dis) - P2 | "Future studies should assess the potential role of TOL-463 as a biofilm disrupter in enhancing likelihood of cure relative to approved therapies, reducing recurrence rates, and combined with traditional antimicrobials. NCT02866227."

Clinical • Journal • P2 data

Placebo-Controlled Study Of TOL-463 Insert for Suppression Of Bacterial Vaginosis (BV) (clinicaltrials.gov) - P2; N=250; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Not yet recruiting ➔ Recruiting

Enrollment open

In vitro activity of EDTA and TOL-463 against Neisseria gonorrhoeae. (PubMed, Diagn Microbiol Infect Dis) - "Time-kill curves revealed that EDTA and TOL-463 inhibit growth similar to penicillin, ciprofloxacin, and azithromycin. Furthermore, synergistic and additive antimicrobial interactions occurred when EDTA and TOL-463 were combined with penicillin or azithromycin, respectively, suggesting that further investigations into these unconventional antimicrobials may be advantageous."

Journal • Preclinical