Oral Zunveyl Approved by FDA for Early Alzheimer Disease

Alpha Cognition (Vancouver, British Columbia, Canada) has announced that the Food and Drug Administration (FDA) approved oral therapy Zunveyl (benzgalantamine), previously known as Alpha-1062, for the treatment of mild-to-moderate Alzheimer disease (AD). Zunveyl is a prodrug of galantamine, an acetylcholinesterase inhibitor (AChEI), which is thought to work by preventing the breakdown of acetylcholine, a neurotransmitter crucial for memory and attention and enhancing its release from presynaptic neurons. Zunveyl was formulated to eliminate drug absorption in the gastrointestinal (GI) tract, addressing common tolerability issues such as GI side effects and insomnia associated with other formulations of galantamine.

Clinical studies demonstrated Zunveyl’s bioequivalence to galantamine immediate-release tablets and extended-release capsules, with minimal adverse events reported. Zunveyl will be available by prescription in pharmacies in the United States starting in the first quarter of 2025.

Commenting on the FDA’s decision, Elaine Peskind, MD, Friends of Alzheimer’s Research Professor of Psychiatry at the University of Washington School of Medicine, said, “This advancement marks a meaningful step forward in improving the quality of life for those living with Alzheimer's and their families. As a geriatric psychiatrist specializing in Alzheimer disease, I am eager to incorporate this new treatment into our practice and see the positive difference it will make.”