FDA

• Ibrexafungerp is indicated for the treatment of vulvovaginal candidiasis (VVC) in adults and post-menarchal pediatric females.
• On September 27, 2023, SCYNEXIS issued a voluntary recall of ibrexfungerp tablets due to cross-contamination with a non-antibacterial beta-lactam drug substance.
  • In May 2025, the FDA removed the hold, and the drug was reported as available in pharmacies (Jan 2026).
  • A phase 3, randomized, double-blind study for patients with invasive candidiasis treated with an IV echinocandin followed by either ibrexafungerp or oral fluconazole (MARIO; NCT05178862) was suspended due to this contamination risk. It is unlikely this phase 3 study will re-open.