Zunveyl FDA Approval History
Last updated by Judith Stewart, BPharm on July 30, 2024.
FDA Approved: Yes (First approved July 26, 2024)
Brand name: Zunveyl
Generic name: benzgalantamine
Dosage form: Delayed-Release Tablets
Previous Name: ALPHA-1062
Company: Alpha Cognition Inc.
Treatment for: Alzheimer's Disease
Zunveyl (benzgalantamine) is an acetylcholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults.
- Alzheimer’s disease is a brain disorder that slowly destroys memory and thinking skills. It is the most common cause of dementia among older adults. While the etiology of cognitive impairment in Alzheimer's disease is not fully understood, it is thought that degeneration of acetylcholine-producing neurons in the brain may be a a contributing factor.
- Benzgalantamine is a prodrug of galantamine, a well established treatment for Alzheimer’s disease first approved in 2001 under the brand name Reminyl (which changed to Razadyne in 2005). Galantamine is a competitive and reversible inhibitor of acetylcholinesterase that is thought to work in the treatment of Alzheimer’s disease by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase.
- Zunveyl is a delayed release oral tablet formulation with an enteric coat designed to reduce the incidence of gastrointestinal adverse effects by remaining inert as it passes through the stomach.
- Zunveyl tablets are administered twice daily with or without food.
- Warnings and precautions associated with Zunveyl include serious skin reactions, increased risk for adverse effects on cardiac conduction, gastrointestinal bleeding, bladder outflow obstruction, and respiratory adverse events in patients with a history of severe asthma or obstructive pulmonary disease.
- Common adverse reactions are the same as galantamine, and include nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
- Benzgalantamine (ALPHA-1062) is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for cognitive impairment with mild traumatic brain injury (mTBI).
Development timeline for Zunveyl
Further information
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