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
- Associated Therapies
- -
ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
- First Posted Date
- 2022-12-29
- Last Posted Date
- 2023-06-28
- Lead Sponsor
- Scynexis, Inc.
- Target Recruit Count
- 6
- Registration Number
- NCT05668429
- Locations
- 🇬🇧
Quotient Sciences Limited, Nottingham, United Kingdom
Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis
- First Posted Date
- 2022-06-01
- Last Posted Date
- 2024-07-10
- Lead Sponsor
- Scynexis, Inc.
- Target Recruit Count
- 150
- Registration Number
- NCT05399641
- Locations
- 🇺🇸
Jefferson University, Philadelphia, Pennsylvania, United States
🇺🇸Wake (Mount Vernon Clinical Research), Atlanta, Georgia, United States
🇺🇸Women's Healthcare Research, San Diego, California, United States
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Interventions
- First Posted Date
- 2019-07-23
- Last Posted Date
- 2023-06-18
- Lead Sponsor
- Scynexis, Inc.
- Target Recruit Count
- 440
- Registration Number
- NCT04029116
- Locations
- 🇺🇸
Chattanooga Medical Research Inc, Chattanooga, Tennessee, United States
🇺🇸Clinical Research Prime - ClinEdge - PPDS, Idaho Falls, Idaho, United States
🇺🇸Women's Healthcare Research Corp, San Diego, California, United States
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
- First Posted Date
- 2019-06-17
- Last Posted Date
- 2021-09-08
- Lead Sponsor
- Scynexis, Inc.
- Target Recruit Count
- 455
- Registration Number
- NCT03987620
- Locations
- 🇺🇸
New Generation Medical Research, Hialeah, Florida, United States
🇺🇸Physician Care Clinical Research LLC, Sarasota, Florida, United States
🇺🇸Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center, Philadelphia, Pennsylvania, United States
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
- First Posted Date
- 2018-11-08
- Last Posted Date
- 2021-09-08
- Lead Sponsor
- Scynexis, Inc.
- Target Recruit Count
- 376
- Registration Number
- NCT03734991
- Locations
- 🇺🇸
Women's Medical Research Group, Clearwater, Florida, United States
🇺🇸Unified Women's Clinical Research Greensboro, Greensboro, North Carolina, United States
🇺🇸Magnolia Ob/Gyn Research Center, LLC, Myrtle Beach, South Carolina, 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
Drug Development Updates
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