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Brexafemme FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 22, 2022.

FDA Approved: Yes (First approved June 1, 2021)
Brand name: Brexafemme
Generic name: ibrexafungerp
Dosage form: Tablets
Company: Scynexis, Inc.
Treatment for: Vaginal Yeast Infection

Brexafemme (ibrexafungerp) is a first-in-class, triterpenoid antifungal agent used to treat vulvovaginal candidiasis (VVC), and to reduce the incidence of recurrent VVC in adults and adolescent females who have started their menstruation.


Development timeline for Brexafemme

Dec  1, 2022Approval Scynexis Announces FDA Approval of Second Indication for Brexafemme (ibrexafungerp tablets) for Reduction in Incidence of Recurrent Vulvovaginal Candidiasis
Jun  2, 2021Approval FDA Approves Brexafemme (ibrexafungerp) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections
Dec  7, 2020Scynexis Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections
Oct 14, 2020Scynexis Announces Submission of New Drug Application to the U.S. Food and Drug Administration for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infection
Jan 30, 2019Scynexis Announces Positive Interim Results from Phase 3 Open-Label FURI Study, Showing Oral Ibrexafungerp's Ability to Treat Refractory Fungal Infections and to Provide an Alternative to Long-Term IV Therapies

Further information

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