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A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease

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Trial Profile

A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Oct 2024

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At a glance

  • Drugs Gildeuretinol (Primary)
  • Indications Stargardt disease
  • Focus Adverse reactions; Registrational
  • Acronyms TEASE
  • Sponsors Alkeus Pharmaceuticals

    • Most Recent Events

    • 17 Oct 2024 According to an Alkeus Pharmaceuticals Media Release, Positive data from Study will be presented at the 128th annual meeting of the American Academy of Ophthalmology (AAO) being held in Chicago October 18-21, 2024.
    • 05 Jun 2023 According to an Alkeus Pharmaceuticals media release, the U.S. FDA has granted Orphan Drug Designation to gildeuretinol (ALK-001). Alkeus plans to submit an NDA for approval of gildeuretinol in 2024.
    • 05 Jun 2023 According to an Alkeus Pharmaceuticals media release, the company announced that it has raised a $150 million Series B financing to support the registration and launch of gildeuretinol (ALK-001) for the treatment of Stargardt disease.The financing was led by Bain Capital Life Sciences, with additional participation by TCGX, Wellington Management and Sofinnova Investments.Joshua Boger, Ph.D.,the founder of Vertex Pharmaceuticals, has joined Alkeus as Executive chairman.

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