FDA approves Alpha Cognition oral Alzheimer's treatment

July 30, 2024

The FDA has approved Alpha Cognition’s Zunveyl (benzgalantamine) for the treatment of mild-to-moderate Alzheimer's disease.

Zunveyl is designed to minimize gastrointestinal absorption, potentially reducing side effects common with existing Alzheimer's medications. The medication is a prodrug of galantamine, first approved in 2001, and enhances cognitive and global function by preventing the breakdown of acetylcholine and potentiating specific receptors.

prodrug is developed by attaching a small side chain to the side of the molecule so that you improve the pharmacokinetics and absorption. Once taken, the side chain falls off in the body, allowing the original main molecule to exert its therapeutic effect. The method can help the drug work better, reduce side effects, improve how it's absorbed and processed, or target specific areas in the body more effectively. 

Clinical studies indicate lower incidences of gastrointestinal side effects and no reported cases of insomnia, addressing key issues that often lead to medication discontinuation.

This approval marks only the second oral Alzheimer's drug approved in over a decade. Last year, the FDA expanded approval to Otsuka's Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer’s disease. 

Vancouver-based Alpha Cognition is also developing Zunveyl in combination with memantine for moderate-to-severe Alzheimer's and as an intranasal formulation for cognitive impairment with mild traumatic brain injury.