Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05399641 | Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis | PHASE3 | COMPLETED | 150 | — | — | May 1, 2022 | Aug 2, 2023 | Jul 10, 2024 | 25 | United States |
| NCT06954493 | Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp | PHASE1 | COMPLETED | 5 | — | — | Jul 12, 2023 | Nov 1, 2023 | Aug 8, 2025 | 1 | United States |
Percentage of participants with complete resolution of signs and symptoms (total VSS score of 0) with no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
To determine the levels of SCY-078 in breast milk in ng/mL, starting pre-dose (Baseline) on Day 1 until 108 hours post first dose. Concentrations of SCY-078 in milk is measured pre-dose, and in milk collected at the following post-dose intervals: 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, 18-24 hours, 24-36 hours, 36-48 hours, 48-72 hours and 72-108 hours.
To measure the levels of SCY-078 in plasma at pre-dose (0 hours), 2, 6, 8 12 hours post dose (prior to the second dose) and 24, 36, 48, 72 and 108 hours post first dose.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Subjects without underlying medical conditions and have isolates other than C glabrata, C krusei, C auris. Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day. |
| Group B (3 Day dosing) | EXPERIMENTAL | Subjects with underlying medical conditions: DM, immunocompromised conditions (e.g. HIV), debilitation, immunosuppressive therapy (e.g. corticosteroids), recurrent VVC (≥3 episodes/year) and/or known to have C glabrata, C krusei or C auris isolates. Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day. |
| Group B (7 Day dosing) | EXPERIMENTAL | Subjects with underlying medical conditions: DM, immunocompromised conditions (e.g. HIV), debilitation, immunosuppressive therapy (e.g. corticosteroids), recurrent VVC (≥3 episodes/year) and/or known to have C glabrata, C krusei or C auris isolates. Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day |
| Open Label Treatment | OTHER | Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H) |
| Name | Type | Description |
|---|---|---|
| Ibrexafungerp | DRUG | Each day dosing will consist of two 150mg tablets taken BID. |
Inclusion Criteria: 1. Subject is a post menarchal female ≥18 years of age at the time of signing the ICF. 2. Subject has a diagnosis of symptomatic VVC that meets the following criteria at the Screening visit: 1. Minimum composite vulvovaginal signs and symptoms score of ≥4 with at least 2 ...