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Ibrexafungerp

DRUG8 trials

Sponsors

Scynexis Inc., Scynexis, Inc.

Conditions

Allergic Bronchopulmonary AspergillosisBlastomycosisCandida InfectionCandida VulvovaginitisChronic Pulmonary AspergillosisCoccidioidomycosisFungal DiseaseHistoplasmosis

Phase 1

ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
CompletedNCT05668429
Scynexis, Inc.Fungal Disease
Start: 2022-12-14End: 2023-01-28Updated: 2023-06-28
Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp
CompletedNCT06954493
Scynexis, Inc.Candida Infection, Vaginal Candidiasis, Vulvovaginal Candidiasis
Start: 2023-07-12End: 2023-11-01Updated: 2025-08-08

Phase 3

Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
CompletedNCT03059992
Scynexis, Inc.Allergic Bronchopulmonary Aspergillosis, Blastomycosis, Chronic Pulmonary Aspergillosis +7
Start: 2017-04-01End: 2023-08-25Updated: 2024-11-20
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
CompletedNCT03734991
Scynexis, Inc.Candida Vulvovaginitis
Start: 2019-01-04End: 2019-09-04Updated: 2021-09-08
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
CompletedNCT03987620
Scynexis, Inc.Candida Vulvovaginitis
Start: 2019-06-07End: 2020-04-29Updated: 2021-09-08
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
CompletedNCT04029116
Scynexis, Inc.Recurrent Vulvovaginal Candidiasis
Start: 2019-10-21End: 2021-11-29Updated: 2023-06-18
Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis
CompletedNCT05399641
Scynexis, Inc.Vulvovaginal Candidiasis
Start: 2022-05-01End: 2023-08-02Updated: 2024-07-10
A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin followed by Oral Ibrexafungerp versus Intravenous Echinocandin followed by Oral Fluconazole (MARIO)
CompletedCTIS2024-511755-18-00
Scynexis Inc.Invasive Candidiasis/ Candidemia
Start: 2022-12-23End: 2025-10-14Target: 72Updated: 2025-09-16

Related Papers

Ibrexafungerp: Mechanism of Action, Clinical, and Translational Science
Clinical and Translational Science2025-09-01
871. Oral Ibrexafungerp Outcomes by Fungal Disease in Patients from an Interim Analysis of a Phase 3 Open-label Study (FURI)
Open Forum Infectious Diseases2022-12-0116 citations
466. All-Cause Mortality in Patients with Invasive Candidiasis or Candidemia from an Interim Analysis of a Phase 3 Open-label Study (FURI)
Open Forum Infectious Diseases2022-12-013 citations
Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306
Journal of Women s Health2022-10-1820 citations
P056 Oral Ibrexafungerp outcomes by fungal disease in patients from an interim analysis of a Phase 3 Open-label Study (FURI)
Medical Mycology2022-09-016 citations
P057 All- cause mortality in patients with invasive Candidiasis or candidemia from an interim analysis of a Phase 3 Open-label Study (FURI)
Medical Mycology2022-09-011 citations
123. Oral Ibrexafungerp Outcomes by Fungal Disease in Patients from an Interim Analysis of a Phase 3 Open-label Study (FURI)
Open Forum Infectious Diseases2021-11-018 citations
992. Oral Ibrexafungerp Outcomes in Patients with Oropharyngeal and Esophageal Candidiasis from an Interim Analysis of a Phase 3 Open-label Study (FURI)
Open Forum Infectious Diseases2021-11-01
983. Outcomes of Candida Bone and Joint Infections in Eight Patients from a Phase 3 Open-label Study (FURI)
Open Forum Infectious Diseases2021-11-01
Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis
Clinical Infectious Diseases2021-09-2234 citations
1248. Efficacy and Safety of Oral Ibrexafungerp in 41 Patients with Refractory Fungal Diseases, Interim Analysis of a Phase 3 Open-label Study (FURI)
Open Forum Infectious Diseases2020-10-0111 citations