- |||||||||| Brexafemme (ibrexafungerp) / SCYNEXIS, GSK, TOL-463 / Toltec Pharma
Review, Journal: Treatment of Vulvovaginal Candidiasis-An Overview of Guidelines and the Latest Treatment Methods. (Pubmed Central) - Aug 26, 2023
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.
- |||||||||| TOL-463 / Toltec Pharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Suppression Of Bacterial Vaginosis (BV) [SUBVert] (clinicaltrials.gov) - Mar 28, 2022
P2, N=82, Completed,
There has been significant new knowledge generated about VVC since the 2015 CDC Guidelines which have led to changing recommendations. Recruiting --> Completed | N=250 --> 82 | Trial completion date: Sep 2022 --> Feb 2022 | Trial primary completion date: Sep 2022 --> Dec 2021
- |||||||||| TOL-463 / Toltec Pharma
Trial completion date, Trial primary completion date: Suppression Of Bacterial Vaginosis (BV) [SUBVert] (clinicaltrials.gov) - Oct 1, 2021
P2, N=250, Recruiting,
Recruiting --> Completed | N=250 --> 82 | Trial completion date: Sep 2022 --> Feb 2022 | Trial primary completion date: Sep 2022 --> Dec 2021 Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022
- |||||||||| TOL-463 / Toltec Pharma
Trial completion date, Trial primary completion date: Suppression Of Bacterial Vaginosis (BV) [SUBVert] (clinicaltrials.gov) - Jul 20, 2020
P2, N=250, Recruiting,
Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022 Trial completion date: Jul 2020 --> Jul 2021 | Trial primary completion date: Jul 2020 --> Jul 2021
- |||||||||| TOL-463 / Toltec Pharma
Clinical, P2 data, Journal: 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 Central) - Apr 10, 2020
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.
- |||||||||| TOL-463 / Toltec Pharma
Preclinical, Journal: In vitro activity of EDTA and TOL-463 against Neisseria gonorrhoeae. (Pubmed Central) - Jun 22, 2019
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.
- |||||||||| TOL-463 / Toltec Pharma
Trial completion: TOL-463 Phase 2 Study for Vaginitis (clinicaltrials.gov) - Jul 23, 2017
P2, N=106, Completed,
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. Active, not recruiting --> Completed
- |||||||||| TOL-463 / Toltec Pharma
Enrollment closed, Trial primary completion date: TOL-463 Phase 2 Study for Vaginitis (clinicaltrials.gov) - May 19, 2017
P2, N=106, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2017 --> Jun 2017
- |||||||||| TOL-463 / Toltec Pharma
New P2 trial: TOL-463 Phase 2 Study (clinicaltrials.gov) - Jun 27, 2016
P2, N=80, Not yet recruiting,
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