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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: 24 Nov 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

    • 14 Nov 2024 According to a Soleno Therapeutics media release, company will be presenting long-term efficacy results from its DCCR clinical development program for the treatment of Prader-Willi syndrome (PWS) at the 62nd Annual European Society for Paediatric Endocrinology (ESPE) Meeting 2024, being held Nov 16-18, 2024 in Liverpool, UK.
    • 08 Oct 2024 According to a Soleno Therapeutics media release, FDA Review Division has determined that there is no need for an advisory committee meeting at this time for the New Drug Application (NDA) for DCCR extended-release tablets for treating Prader-Willi syndrome (PWS). However, the Division's review team will consider the potential need for the same during their ongoing review. The NDA was designated for Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of 27 Dec 2024.
    • 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.

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