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A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 May 2024

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At a glance

  • Drugs Diazoxide (Primary)
  • Indications Prader-Willi syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY PWS
  • Sponsors Soleno Therapeutics

    • Most Recent Events

    • 30 Apr 2024 According to a Soleno Therapeutics media release, company announced the publication of the comparison of results from the Companys Phase 3 placebo-controlled study (C601) and open-label extension study (C602) evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets in patients with Prader-Willi syndrome (PWS), to data from the PATH for PWS (PATH) natural history study, in the Journal of Neurodevelopmental Disorders.
    • 29 Apr 2024 According to a Soleno Therapeutics media release, company remain focused on preparing NDA submission for DCCR in PWS, which they continue to expect will occur in mid-2024.
    • 29 Apr 2024 According to a Soleno Therapeutics media release, based on an assessment of the preliminary data from the Phase 3 clinical development program, U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to diazoxide choline for the treatment of adults and children ages 4 years and older with genetically confirmed Prader-Willi syndrome (PWS) who have hyperphagia.
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