Alzinova receives Fast Track designation from US FDA
Alzinova has announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the company’s vaccine candidate ALZ-101 in Alzheimer’s disease.
October 6, 2025
“Fast Track designation for ALZ-101 is an important recognition of the unmet patient need in Alzheimer’s disease. This designation follows encouraging safety and efficacy data from our completed Phase 1b clinical trial, demonstrating early indication of clinical benefit as well as mechanistic data supporting the activity of ALZ-101,” says Tord Labuda, CEO of Alzinova.
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Even though many have tried and few succeeded in the quest to find viable treatments for neurodegenerative diseases, Nordic drug developers continue to take different approaches to crack the riddle.
The US FDA Fast track process is 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.
Published: October 6, 2025
