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# F2G Gains ‘Breakthrough’ for Olorofim in Mold Infections
- URL: https://www.fdaweb.com/f2g-gains-breakthrough-for-olorofim-in-mold-infections/
- Published: 2019-11-11T12:00:00.000Z
- Updated: 2026-09-14T15:52:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145475

FDA has granted F2G Ltd. a breakthrough therapy designation for olorofim for treating invasive mold infections in patients with limited or no treatment options, including *aspergillosis* refractory or intolerant to currently available therapy, and infections due to *Lomentospora prolificans*, *Scedosporium*, and *Scopulariopsis* species. The company says that olorofim is the first antifungal agent to be granted such a designation. It is currently being investigated in an open-label single-arm Phase 2b study (clinicaltrials.gov identifier:NCT03583164) in patients with proven invasive fungal disease or probable invasive *aspergillosis* and either refractory disease, resistance, or intolerance to available agents. Preliminary data from the study were provided to FDA to support the designation.