13 completed, 2 terminated. 7 Phase 3, 4 Phase 1, 4 Phase 2.
By phase and status
Follow ibrexafungerp: new trials by email Literature Review of ibrexafungerp trials Research Report on ibrexafungerp
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp Ibrexafungerp - Vulvovaginal Candidiasis, Candida Infection Phase 1 Completed 5 2023-07-12 2025-08-08 ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects Ibrexafungerp - Fungal Disease Phase 1 Completed 6 2022-12-14 2023-06-28 A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole SCY-078, Fluconazole, Echinocandin - Candidiasis, Invasive, Candidemia Phase 3 Terminated 68 2022-08-03 2026-08-10 Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis Ibrexafungerp - Vulvovaginal Candidiasis Phase 3 Completed 150 2022-05-01 2024-07-10 Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects PRA, SCY-078 plus PRA - Pharmacokinetics Phase 1 Completed 28 2019-11-22 2020-09-02 Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) Fluconazole Tablet, IBREXAFUNGERP, Placebo oral tablet - Recurrent Vulvovaginal Candidiasis Phase 3 Completed 440 2019-10-21 2023-06-18 Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects DAB, SCY-078 plus DAB - Pharmacokinetics Phase 1 Completed 36 2019-09-09 2020-09-02 Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis Ibrexafungerp, Placebo - Candida Vulvovaginitis Phase 3 Completed 455 2019-06-07 2021-09-08 Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis SCY-078, Voriconazole, Oral Placebo Tablets - Invasive Pulmonary Aspergillosis Phase 2 Terminated 22 2019-01-22 2024-08-09 Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303) Ibrexafungerp, Placebo - Candida Vulvovaginitis Phase 3 Completed 376 2019-01-04 2021-09-08 Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) SCY-078 - Candidiasis, Invasive, Candidemia Phase 3 Completed 30 2017-11-15 2024-07-03 Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis Fluconazole, SCY-078 - Candida Vulvovaginitis Phase 2 Completed 186 2017-08-01 2021-08-12 Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment Ibrexafungerp - Invasive Candidiasis, Mucocutaneous Candidiasis Phase 3 Completed 233 2017-04-01 2024-11-20 Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis SCY-078, Fluconazole - Vulvovaginal Candidiasis Phase 2 Completed 96 2015-11-01 2019-07-12 Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis SCY-078, Fluconazole, Micafungin - Mycoses, Candidiasis, Invasive Phase 2 Completed 27 2014-09-01 2024-06-25
Conditions studied Candidiasis, Vulvovaginal (8) · Candidiasis, Invasive (4) · Candidemia (3) · Mycoses (3) · Invasive Pulmonary Aspergillosis (2) · Aspergillosis (1) · Aspergillosis, Allergic Bronchopulmonary (1) · Blastomycosis (1) · Candidiasis (1) · Candidiasis, Chronic Mucocutaneous (1) · Candidiasis, Oral (1) · Coccidioidomycosis (1) · Histoplasmosis (1) · Torulopsis (1) · Vaginitis (1)
Sponsors Scynexis, Inc. (15)
Countries United States (11) · Germany (4) · South Africa (4) · Australia (2) · Belgium (2) · Bulgaria (2) · Canada (2) · Pakistan (2) · Spain (2) · United Kingdom (2) · Austria (1) · China (1) · Dominican Republic (1) · El Salvador (1) · France (1)
Top investigators David Angulo, MD (7) · Lori Tierney (1) · Nkechi Azie, MD (1)
Results publications PMID 36255448 , PMID 40970688 , PMID 34555149
NIH funding 2017 (1) , 2018 (1)