Ibrexafungerp
- Generic Name
- Ibrexafungerp
- Brand Names
- Brexafemme
- Drug Type
- Small Molecule
- Chemical Formula
- C44H67N5O4
- CAS Number
- 1207753-03-4
- Unique Ingredient Identifier
- A92JFM5XNU
- Background
Ibrexafungerp, also known as SCY-078 or MK-3118, is a novel enfumafungin derivative oral triterpene antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as a vaginal yeast infection. It was developed out of a need to treat fungal infections that may have become resistant to echinocandins or azole antifungals. Ibrexafungerp is orally bioavailable compared to the echinocandins caspofungin, micafungin, and anidulafungin; which can only be administered parenterally. Similar to echinocandins, ibrexafungerp targets the fungal β-1,3-glucan synthase, which is not present in humans, limiting the chance of renal or hepatic toxicity.
Ibrexafungerp was granted FDA approval on 1 June 2021.
- Indication
Ibrexafungerp is indicated in the treatment of vulvovaginal candidiasis in post-menarchal patients. It is also indicated for the reduction in the incidence of recurrent vulvovaginal candidiasis.
- Associated Conditions
- Recurrent Vulvovaginal Candidiasis, Vulvovaginal Candidiasis
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
- First Posted Date
- 2017-08-17
- Last Posted Date
- 2021-08-12
- Lead Sponsor
- Scynexis, Inc.
- Target Recruit Count
- 186
- Registration Number
- NCT03253094
- Locations
- 🇺🇸
Drexel University, Philadelphia, Pennsylvania, United States
🇺🇸Wake Research Associates, LLC, Raleigh, North Carolina, United States
🇺🇸New Age Medical Research Corp., Miami, Florida, United States
Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
- Conditions
- Invasive CandidiasisAllergic Bronchopulmonary AspergillosisChronic Pulmonary AspergillosisMucocutaneous CandidiasisCoccidioidomycosisBlastomycosisOther Emerging FungiHistoplasmosisInvasive Pulmonary AspergillosisRecurrent Vulvovaginal Candidiasis
- Interventions
- First Posted Date
- 2017-02-23
- Last Posted Date
- 2024-11-20
- Lead Sponsor
- Scynexis, Inc.
- Target Recruit Count
- 233
- Registration Number
- NCT03059992
- Locations
- 🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States
🇺🇸University of Texas Health Science Center at Houston, Houston, Texas, United States
🇺🇸Emory University Hospital Midtown, Atlanta, Georgia, United States
Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
- First Posted Date
- 2016-02-10
- Last Posted Date
- 2019-07-12
- Lead Sponsor
- Scynexis, Inc.
- Target Recruit Count
- 96
- Registration Number
- NCT02679456
- Locations
- 🇩🇴
Hospital Dr. Francisco E. Moscoso Puello, Santo Domingo, Dominican Republic
🇩🇴Instituto Dermatologico y Cirugia de Piel, Santo Domingo, Dominican Republic
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
- Conditions
- MycosesCandidiasis, InvasiveCandidemia
- Interventions
- First Posted Date
- 2014-09-19
- Last Posted Date
- 2024-06-25
- Lead Sponsor
- Scynexis, Inc.
- Target Recruit Count
- 27
- Registration Number
- NCT02244606
- Locations
- 🇺🇸
University of Texas Health Science Center at Houston, Houston, Texas, United States
🇺🇸University of Miami, Miami, Florida, United States
🇺🇸South Texas Veterans Healthcare System, San Antonio, Texas, United States
Drug Development Updates
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