ALPHA-1062 FDA Approval Status
Last updated by Judith Stewart, BPharm on Oct 4, 2023.
FDA Approved: No
Brand name: ALPHA-1062
Company: Alpha Cognition Inc.
Treatment for: Alzheimer's Disease
ALPHA-1062 is a pro-drug of the approved acetylcholinesterase inhibitor (AChEI) galantamine in development for the treatment of mild-to-moderate Alzheimer’s disease.
- 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.
- Galantamine is 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.
- ALPHA-1062 is a pro-drug of galantamine in a delayed release oral tablet formulation that is designed to reduce gastrointestinal adverse effects by remaining inert as it passes through the stomach.
- 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 ALPHA-1062
| Date | Article |
|---|---|
| Sep 27, 2023 | Alpha Cognition Announces Submission of New Drug Application to the FDA for ALPHA-1062 for Mild-to-Moderate Alzheimer’s Disease |
Further information
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