The FDA has approved benzgalantamine, formerly known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer's disease. Developed by Alpha Cognition, benzgalantamine is an oral therapy with a dual mechanism of action aimed at mitigating certain tolerability issues associated with Alzheimer's disease medications while maintaining the efficacy and long-term benefit profile of galantamine.
The approval of benzgalantamine was based on data from three bioavailability studies in healthy adults demonstrating bioequivalence and tolerability compared to galantamine immediate-release tablets and galantamine extended-release capsules. The treatment is designed to eliminate absorption in the gastrointestinal tract, potentially addressing tolerability concerns.
As a prodrug of galantamine, an acetylcholinesterase inhibitor, benzgalantamine is thought to exert its therapeutic effect by preventing the breakdown of acetylcholine, a key neurotransmitter involved in memory, motivation, and attention functions. Additionally, it acts as an allosteric potentiator of α-7 nicotinic acetylcholine and α4β2 receptors, facilitating the release of acetylcholine from presynaptic neurons.
Alpha Cognition expects benzgalantamine to be available in the first quarter of 2025. Health care professionals can access the full prescribing information on the company's website.
References:
- Alpha Cognition. FDA approves benzgalantamine for the treatment of mild-to-moderate Alzheimer's disease [press release]. July 29, 2024.
- Benzgalantamine prescribing information. Alpha Cognition; 2024.
