drugset
Drugs / DCCR
last change Jun 2025 re-read 3 minutes ago

DCCR

Developed for
Prader-Willi syndrome
Investigated by
Soleno Therapeutics, Inc.

Trials 1

today NCT04086810 · Ph 3
2020202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT04086810 Oct 2019 Prader-Willi syndrome Soleno Therapeutics, Inc. Withdrawn Met primary

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2025-06-25 Soleno Therapeutics, Inc. Results Soleno Therapeutics Highlights New Data on VYKAT(TM) XR at the 2025 United in Hope: International Prader-Willi Syndrome Conference soleno.life ↗
For those individuals who are managed with strict food controls, these data suggest that they had more hyperphagia symptoms at baseline yet still saw a statistically significant, clinically meaningful benefit from treatment with VYKAT XR.
2025-05-20 Soleno Therapeutics, Inc. Results Soleno Therapeutics Announces Data Presentation Showing that Resumption of Treatment with VYKAT(TM) XR after a Randomized Withdrawal Period was Associated with Significant Improvements in Hyperphagia and Behavioral Symptoms in Participants with Prader-Willi Syndrome soleno.life ↗
The presentation showed that resumption of VYKAT XR treatment in participants with PWS following a 16-week randomized withdrawal was associated with significant improvements in both hyperphagia and behavioral symptoms.
2024-11-26 Soleno Therapeutics, Inc. Regulatory Soleno Therapeutics Announces FDA Extension of Review Period for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome soleno.life ↗
The FDA determined that responses to recent information requests constituted a major amendment to the NDA, resulting in the extension of the PDUFA goal date by three months.
2024-10-08 Soleno Therapeutics, Inc. Regulatory Soleno Therapeutics Announces Regulatory Update on DCCR (diazoxide choline) Extended-Release Tablets to Treat Prader-Willi Syndrome soleno.life ↗
The FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment
2020-06-08 Soleno Therapeutics, Inc. Results Soleno Therapeutics Announces Top-line Results from Phase III Trial of DCCR for Treatment of Prader-Willi Syndrome soleno.life ↗
The study did not meet its primary endpoint of change from baseline in hyperphagia.
2019-09-24 Soleno Therapeutics, Inc. Results Soleno Therapeutics Announces Publication of Results from Previously Completed Phase II Trial of DCCR for Treatment of Prader-Willi Syndrome soleno.life ↗
2018-11-15 Soleno Therapeutics, Inc. Results Soleno Therapeutics Presents Clinical Fat Loss Data on DCCR at the Obesity Society Meeting 2018 soleno.life ↗
The clinical data presented at the Obesity Society Meeting demonstrates that in addition to improving hyperphagia, treatment with DCCR also leads to statistically significant reductions in body fat in PWS patients.

All press releases naming this drug 56 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as DCCR ClinicalTrials.gov intervention name — accepted as the source's own label NCT04086810 ↗
Route Oral “Once daily oral administration” NCT04086810 ↗