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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: 28 Aug 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

    • 27 Aug 2024 According to a Soleno Therapeutics media release, the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for DCCR for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia.
    • 28 Jun 2024 According to a Soleno Therapeutics media release, company today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia. Company has requested Priority Review of the NDA, which would provide a target review period of six months by the FDA after the NDA has been accepted.
    • 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.

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