Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CD101 Vaginal · 1 trial · 5 indications
adverse events, clinical chemistry and hematology, pelvic exams
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours. |
| Cohort 2 | EXPERIMENTAL | CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours. |
| Cohort 3 | ACTIVE_COMPARATOR | Oral fluconazole (150mg) administered on day 1. |
| Name | Type | Description |
|---|---|---|
| CD101 Vaginal Gel (3%) | DRUG | CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2 |
| CD101 External gel (1%) | DRUG | CD101 external gel (1%) applied topically twice daily over 72 hours as needed |
| CD101 Vaginal Ointment (6%) | DRUG | CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1 |
| CD101 External ointment (1%) | DRUG | CD101 external ointment (1%) applied topically twice daily over 72 hours as needed |
| Fluconazole | DRUG | oral fluconazole (150mg) on Day 1 |
Inclusion Criteria: * moderate to severe acute vulvovaginal candidiasis (severity score \>7) * positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species * vaginal pH \<4.5 for subjects with...
CD101 Vaginal is an investigational small molecule being developed for the treatment of candidiasis, specifically vulvovaginal candidiasis, which is a vaginal yeast infection. It is being studied as a topical treatment for acute vaginal yeast infections in adult women.
CD101 Vaginal is an antifungal small molecule. It is designed to treat vulvovaginal candidiasis, a fungal infection caused by Candida species. The drug is administered vaginally to deliver the antifungal agent directly to the site of infection.
CD101 Vaginal is being developed by Cidara Therapeutics, Inc., a biopharmaceutical company. Cidara Therapeutics is publicly traded on the Nasdaq under the ticker symbol CDTX.
CD101 Vaginal is in Phase 2 clinical development. It has completed one Phase 2 clinical trial, the RADIANT study, which evaluated the drug in subjects with acute vaginal yeast infections. The drug is still investigational and has not been approved by regulatory authorities.
CD101 Vaginal has been studied in one clinical trial, the RADIANT study (NCT02733432). This Phase 2 trial was a randomized, active-controlled study that compared CD101 Vaginal to standard of care in 126 female subjects with acute vaginal yeast infections. The trial was conducted in the United States and has been completed.
CD101 Vaginal is a formulation of the antifungal drug CD101, which is being developed by Cidara Therapeutics. The vaginal formulation is specifically designed for the treatment of vulvovaginal candidiasis, while other formulations of CD101 may be studied for different indications.