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A pivotal relative bioavailability study assessing Alpha-1062 for Alzheimer's disease

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Trial Profile

A pivotal relative bioavailability study assessing Alpha-1062 for Alzheimer's disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jul 2024

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At a glance

  • Drugs Benzgalantamine (Primary) ; Galantamine
  • Indications Alzheimer's disease
  • Focus Pharmacokinetics; Registrational
  • Acronyms BABE
  • Sponsors AlphaCognition

Most Recent Events

  • 29 Jul 2024 According to an Alpha Cognition media release, company announces that the U.S. Food and Drug Administration (FDA) has granted approval for ZUNVEYL (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer's disease.
  • 22 Feb 2024 According to an AlphaCognition media release, company announced that it has filed a new composition-of-matter patent that secures broad protection for its lead asset, ALPHA-1062, currently under review by the FDA for mild-to-moderate Alzheimer's Disease based on findings in the clinical trial work the company completed and further demonstrates the uniqueness of ALPHA-1062.
  • 07 Dec 2023 According to an Alpha Cognition media release, the U.S. Food and Drug Administration (FDA) has completed its filing review and has accepted the companys New Drug Application (NDA) for ALPHA-1062, for the treatment of mild-to-moderate Alzheimer's Disease. The NDA has been granted a Prescription Drug User Fee Act (PDUFA) goal date of July 27th, 2024.

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