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# Scynexis Clinical Hold Lifted on Antifungal
- URL: https://www.fdaweb.com/scynexis-clinical-hold-lifted-on-antifungal/
- Published: 2025-05-16T12:00:00.000Z
- Updated: 2026-09-14T15:12:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159197

FDA has lifted a clinical hold against Scynexis’s ibrexafungerp that will allow it to proceed with its Phase 3 MARIO study evaluating its use as a non-azole, oral step-down for patients with invasive candidiasis and candidemia. The company says ibrexafungerp, if approved, could give healthcare providers the opportunity to step-down their patients to a non-azole oral therapy that retains the glucan synthase inhibition of the intravenous-only echinocandins, which are the gold standard for treating *Candida* infections, potentially allowing for faster discharge from the hospital.

Ibrexafungerp is being developed under a licensing agreement with GSK. The first-in-class antifungal is currently approved for treating vulvovaginal candidiasis (VVC) and for reducing the incidence of recurrent VVC.