ALZPROTECT Receives U.S. FDA Fast Track Designation for AZP2006 (Ezeprogind®) in Progressive Supranuclear Palsy (PSP)
Fast Track designation follows U.S. IND clearance and is designed to facilitate development and expedite review of AZP2006 in PSP
Lille, France, August 24, 2026 — Alzprotect today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AZP2006 (Ezeprogind®) for the treatment of Progressive Supranuclear Palsy (PSP). The designation was granted under IND 169279 following Alzprotect’s request. The FDA concluded that AZP2006 meets the criteria for Fast Track designation for the treatment of PSP.
“Receiving Fast Track designation from the FDA is an important milestone for AZP2006 and for our PSP program,” said Philippe Verwaerde, PhD, President & Chief Scientific Officer of Alzprotect. “Following the recent clearance of our U.S. IND, this designation provides an opportunity for closer and more frequent interaction with the FDA as we advance Ezeprogind. For patients living with PSP, where there is still no approved disease-modifying therapy, accelerating the development of promising new approaches is critical.”
The Fast Track designation follows the FDA clearance of Alzprotect’s IND for AZP2006 in May 2026, which enabled U.S. clinical development. AZP2006 has also been selected as one of the first drug candidates for planned evaluation in the NIH/NIA-funded Progressive Supranuclear Palsy Trial Platform (PTP), supporting Alzprotect’s strategy to advance the program in the United States.
About FDA Fast Track Designation
The FDA Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and address an unmet medical need. Fast Track designation provides opportunities for more frequent meetings and written communication with the FDA and may allow rolling review of a future marketing application. A Fast Track product may also be eligible for Accelerated Approval and Priority Review if the applicable criteria are met.
About Progressive Supranuclear Palsy (PSP)
PSP is a rare, rapidly progressive neurodegenerative tauopathy characterized by postural instability and falls, ocular motor dysfunction, movement abnormalities, and cognitive impairment. The disease leads to progressive loss of autonomy and has a major impact on patients and caregivers. There are currently no approved disease-modifying treatments for PSP in the United States.