
Alpha Cognition has received approval from the US Food and Drug Administration (FDA) approval for Zunveyl (benzgalantamine) to treat mild-to-moderate Alzheimer’s disease (AD).
The biopharmaceutical company, which is based in Canada, is focused on developing treatments for neurodegenerative diseases.
Zunveyl, formerly known as ALPHA-1062, is the firm’s patented oral therapy for Alzheimer’s disease. It features a dual mechanism of action to remove drug absorption in the gastrointestinal tract (GI) tract.
In December 2023, the FDA accepted Alpha Cognition’s new drug application (NDA) for ALPHA-1062.
The approval has been granted based on comprehensive chemistry, manufacturing, and control data from four studies.
The results demonstrated its bioequivalence and tolerability compared to galantamine immediate-release tablets and galantamine extended-release capsules.
In addition, the clinical trials reported minimal adverse events associated with Zunveyl.
The efficacy of the oral therapy was assessed through three bioavailability studies in healthy adults, comparing it to both galantamine immediate-release tablets and galantamine extended-release capsules.
Across all studies, gastrointestinal adverse events with Zunveyl were less than 2%, and no cases of insomnia were reported.
Additionally, clinical trials involving galantamine, the active component of Zunveyl, have shown sustained enhancements in cognitive function and quality of life over long-term use.
Alpha Cognition CEO Michael McFadden said: “The approval of Zunveyl is a pivotal moment in the fight against Alzheimer’s disease as it is only the second oral AD treatment to be approved in more than a decade.
“Zunveyl was designed to addresses a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes.
“We are delighted, as this represents a major breakthrough in Alzheimer’s treatment, providing hope to millions of patients, families, and caregivers affected by this devastating disease.”
Zunveyl is set to be available by prescription at pharmacies across the US starting in Q1 2025.
In addition, the drug is being developed in combination with memantine for the treatment of Alzheimer’s dementia, and as an intranasal formulation to address cognitive impairment associated with mild traumatic brain injury.