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: 02 Jul 2025

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At a glance

25 Jun 2025 Results presented in Soleno Therapeutics Media Release
25 Jun 2025 According to a Soleno Therapeutics media release, the company presented new data on VYKATTM XR , at the 2025 United in Hope: International Prader-Willi Syndrome Conference.
22 May 2025 According to a Soleno Therapeutics media release, company announced that Soleno Marketing Authorization Application (MAA) seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets (previously referred to as DCCR) for the treatment of adults and children four years and older with Prader-Willi syndrome (PWS) who have hyperphagia had been validated by the European Medicines Agency (EMA).

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