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Also known as CD101 Vaginal Gel (3%)
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 vulvovaginal candidiasis, a vaginal yeast infection. It is a topical vaginal gel formulation studied in adult women with acute vaginal yeast infections. It has not been approved by the FDA and remains in clinical development.
CD101 Vaginal is being developed by Cidara Therapeutics, Inc., which trades on the Nasdaq under the ticker CDTX. The company is the sponsor of the clinical program evaluating the vaginal gel formulation for vulvovaginal candidiasis.
CD101 Vaginal is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
CD101 Vaginal has been studied in the Phase 2 RADIANT trial, NCT02733432, titled CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections. The trial enrolled 126 participants in the United States, was randomized and active-controlled, and is now completed.
Yes. CD101 Vaginal Gel (3%) is an alternative name for CD101 Vaginal. Both names refer to the same Cidara Therapeutics investigational product, a 3% vaginal gel formulation of CD101 being evaluated for the treatment of vulvovaginal candidiasis.
The RADIANT Phase 2 trial of CD101 Vaginal enrolled women aged 18 years and older with acute vaginal yeast infections. It was a randomized, active-controlled study comparing CD101 with standard of care, and it enrolled 126 participants across sites in the United States.