Alzprotect receives FDA clearance for AZP2006 trial in PSP
Thursday, May 28, 2026
Alzprotect has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug (IND) application for AZP2006 (Ezeprogind®) to treat Progressive Supranuclear Palsy (PSP). The clearance allows the company to begin clinical development of AZP2006 in the United States.
The company stated that the FDA decision supports expansion of its clinical development activities in the US to assess the potential of AZP2006 for PSP, a severe neurodegenerative disease that currently has no approved disease-modifying treatments.
Alzprotect said the IND clearance also aligns US and European regulatory pathways and enables the launch of clinical trials in the United States for patients with PSP.
The approval further supports the company’s planned participation in the Progressive Supranuclear Palsy Trial Platform, funded by the National Institutes of Health and the National Institute on Aging. AZP2006 has been selected as one of the first treatment candidates to be evaluated in the programme, supporting Alzprotect’s lysosomal dysfunction approach for PSP research.
PSP is a rare and rapidly progressing tau-related neurological disorder associated with balance problems, falls, eye movement disorders and cognitive decline. There are currently no approved disease-modifying therapies for PSP in the US.
Source: businesswire.com
