The FDA has granted FRF-001 Fast Track Designation
New York — February 18, 2026 —The Food and Drug Administration (FDA) has granted FRF-001 Fast Track Designation, for the treatment of FOXG1 syndrome. This important designation comes on the heels of FDA clearing the IND application for initiation of a first-in-human Ph1/2 clinical trial, and adds to the Orphan Drug and Rare Pediatric Disease designations granted to FRF-001 recently.
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
With Fast Track designation, FRF-001 will be eligible for more frequent meetings and communication with FDA and enable the potential for a priority review.
Information pertaining to the clinical trial will be available on ClinicalTrials.gov
About the FOXG1 Research Foundation
The FOXG1 Research Foundation is a global, parent-led nonprofit organization founded in 2017 with the mission to improve the lives of every person and family impacted by FOXG1 syndrome. FRF advances research, builds community, and is pioneering a new blueprint for rare disease drug development—accelerating the path to life-changing therapies for children worldwide. Learn more at FOXG1Research.org.
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