FDA Approves Alpha Cognition's Delayed-Release Alzheimer's Drug Zunveyl

Alpha Cognition has recently launched a new symptomatic medication for Alzheimer’s disease, marking a significant development amid the surge of treatments targeting the condition’s believed root causes. The U.S. Food and Drug Administration (FDA) has approved Alpha Cognition's benzgalantamine, an oral prodrug of galantamine, for treating mild-to-moderate Alzheimer’s disease. This new drug will be marketed under the brand name Zunveyl.

Zunveyl is designed to be taken twice a day, starting with a dose of 5 mg. Patients are expected to gradually increase their dosage to a maintenance level of 10 mg, with the possibility of reaching a maximum dose of 15 mg. As a prodrug, benzgalantamine remains inactive as it travels through the stomach, effectively curbing the gastrointestinal side effects often associated with galantamine, such as nausea, vomiting, and decreased appetite. These side effects are substantial barriers to treatment adherence, with about 55% of Alzheimer’s patients discontinuing their medication within a year due to these issues.

Zunveyl addresses Alzheimer’s symptoms through a dual mechanism. Firstly, it inhibits the breakdown of acetylcholine, a neurotransmitter essential for memory, motivation, and attention. Secondly, it stimulates the release of acetylcholine from presynaptic neurons. Elaine Peskind, M.D., a professor at the University of Washington School of Medicine, highlighted that Zunveyl combines the proven efficacy of galantamine with enhanced tolerability, which is expected to offer physicians a valuable option for treating patients.

The FDA’s approval of Zunveyl was facilitated by data showing its bioequivalence and better tolerability compared to traditional galantamine in both immediate- and extended-release forms. Alpha Cognition conducted three bioavailability studies in healthy adults, comparing Zunveyl with galantamine tablets. These trials indicated that Zunveyl did not cause insomnia and resulted in gastrointestinal side effects in fewer than 2% of patients.

Alpha Cognition plans to launch Zunveyl in U.S. pharmacies beginning in the first quarter of 2025, marking the company’s first commercial product. This approval comes at a time when the Alzheimer’s treatment landscape is evolving rapidly. Since the controversial approval of Eisai and Biogen’s Aduhelm in 2021, several new drugs, including Leqembi and Eli Lilly’s Kisunla, have emerged, aiming to combat Alzheimer’s.

Unlike Zunveyl, which focuses on alleviating Alzheimer’s symptoms, Leqembi and Kisunla target the disease’s progression by eliminating beta-amyloid proteins from the brain. These proteins can accumulate over time, disrupting the cellular networks responsible for memory and cognition.

Alpha Cognition's new med offers a promising alternative for patients who struggle with the side effects of existing Alzheimer's treatments, potentially improving adherence and overall quality of life. As the company prepares for Zunveyl’s commercial release, the Alzheimer’s treatment landscape continues to expand, giving hope to millions affected by this debilitating condition.