Drugs / DCCR
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | Prader-Willi syndrome due to paternal deletion of 15q11q13 type 2 | 2025-05-07 | “seeking marketing approval of DCCR (marketed in the U.S. as VYKAT XR) to patients with PWS in the E.U.” soleno.life ↗ “Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA)” soleno.life ↗ |
| Filed | US (FDA) | — | Prader-Willi syndrome due to paternal deletion of 15q11q13 type 2 | 2024-06-28 | “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” soleno.life ↗ “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of DCCR” soleno.life ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03714373 | Oct 2018 → Aug 2023 | Prader-Willi syndrome | Soleno Therapeutics, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2026-01-05 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Publication of Results from Pivotal Study of VYKAT™ XR in the Journal of Clinical Endocrinology and Metabolism soleno.life ↗ |
| 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. |
| 2025-05-22 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Announces Submission and EMA Validation of Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets for the Treatment of Hyperphagia in Patients with Prader-Willi Syndrome soleno.life ↗ |
| 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. |
| 2025-05-15 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Presentations Featuring VYKAT(TM) XR in Prader-Willi Syndrome at PES 2025 soleno.life ↗
Resuming diazoxide choline extended-release (DCCR) after 16-week randomized withdrawal is associated with significant improvements in hyperphagia and behavioral symptoms in PWS (Study C614) |
| 2025-03-26 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Announces U.S. FDA Approval of VYKAT™ XR to Treat Hyperphagia in Prader-Willi Syndrome soleno.life ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS). |
| 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 |
| 2024-08-27 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and Priority Review of NDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome soleno.life ↗ |
| 2024-06-28 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Announces Submission of New Drug Application to the U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets for the Treatment of Prader-Willi Syndrome soleno.life ↗ |
| 2024-04-30 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Peer-Reviewed Publication of Data Comparing DCCR Treatment to the Natural History of Prader-Willi Syndrome soleno.life ↗
Hyperphagia: Participants treated with DCCR showed highly statistically significant and clinically meaningful improvement with DCCR administration relative to participants in the PATH study at 6 and 12 months (p<0.001 for both comparisons). |
| 2024-04-29 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Receives Breakthrough Therapy Designation from U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome (PWS) soleno.life ↗ |
| 2023-11-07 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results soleno.life ↗
Announced positive statistically significant top-line data from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS). |
| 2023-11-06 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Peer-Reviewed Publication of Results from Long-Term Open-Label Study of DCCR in Prader-Willi Syndrome soleno.life ↗
Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced publication of one-year results from the Phase 3 DESTINY PWS study and the open-label extension period of Study C602 evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets for patients with Prader-Willi syndrome (PWS). |
| 2023-09-26 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Positive Statistically Significant Top-line Results from Randomized Withdrawal Period of Study C602 of DCCR for Prader-Willi Syndrome soleno.life ↗
“We are delighted with the highly statistically significant results from the randomized withdrawal phase of Study C602,” said Anish Bhatnagar , M.D., Chief Executive Officer of Soleno. |
| 2023-01-26 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Peer-Reviewed Publication of Results from Previously Completed Phase 3 Trial of DCCR for Treatment of Prader-Willi Syndrome soleno.life ↗
Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that results from the Company’s previously completed Phase 3 DESTINY PWS (C601) trial of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi Syndrome (PWS) have been published in a peer-reviewed journal. |
| 2022-07-20 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of Prader-Willi Syndrome soleno.life ↗
FDA acknowledges that data from a randomized withdrawal period of Study C602 have the potential to support an NDA submission |
| 2022-07-11 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Presentation of DCCR Data at the 11th International Prader-Willi Syndrome Organisation Conference soleno.life ↗
The presentations by Mr. Pittman and Ms. Bolding included the results from the analysis of caregiver interviews conducted after at least 12 months of investigational, open-label DCCR treatment. |
| 2022-06-13 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Presents Long Term Data for DCCR Showing Metabolic and Body Composition Improvements in Patients with PWS soleno.life ↗
Patients (n=82) experienced improvements in body composition, as evidenced by statistically significant changes in lean body mass (p<0.0001) and the ratio of lean body mass to fat mass (p=0.0005), based on DXA scanning. |
| 2022-05-02 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Presentation of Long-Term Hyperphagia and Behavioral Data in Patients Receiving DCCR for Treatment of Prader-Willi Syndrome soleno.life ↗
Results Show Significant Improvements in Hyperphagia and PWS-Related Behaviors in DCCR-Treated Patients |
| 2021-09-08 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Positive Data Showing Continued Significant Improvements in Symptoms of PWS following One Year Treatment with DCCR soleno.life ↗
today announced top-line results from the Company’s ongoing open-label extension study, C602, evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets for patients with Prader-Willi syndrome (PWS) and its comparison to data from the PATH for PWS natural history study. |
| 2021-07-06 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of Prader-Willi Syndrome soleno.life ↗
The FDA continued to assert that based on the data they have seen to date, an additional clinical trial is necessary for the submission of a New Drug Application (NDA). |
| 2021-06-02 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Receives Orphan Drug Designation from FDA for Diazoxide Choline for the Treatment of Glycogen Storage Disease Type 1a soleno.life ↗
Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational drug, DCCR (diazoxide choline) Extended-Release tablets, Orphan Drug Designation for the treatment of Glycogen Storage Disease Type 1a (GSD 1a), or von Gierke disease. |
| 2021-05-04 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Presentation of Positive Behavioral Data from Ongoing Extension Study of DCCR for Treatment of Prader-Willi Syndrome soleno.life ↗
Through the 48 interviews, 39 behavioral outcomes were identified in seven outcome domains, with an average of 22±5.9 behaviors reported. |
| 2021-03-08 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of Prader-Willi Syndrome soleno.life ↗
Following its review of the data submitted by Soleno, the FDA informed the Company on March 5, 2021 that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR in PWS. |
| 2021-02-05 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Provides Recap of Key Opinion Leader Webinar on DCCR for Treatment of Prader-Willi Syndrome soleno.life ↗
Our analysis of the data through March 1, 2020 found statistically significant differences between DCCR and placebo patients for the primary and all key secondary endpoints. |
| 2020-11-10 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2020 Financial Results soleno.life ↗
Announced updated top-line results from Phase III DESTINY PWS (C601) study evaluating once-daily Diazoxide Choline Controlled-Release (DCCR) tablets for patients with Prader Willi Syndrome (PWS) |
| 2020-11-03 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Presentation of Body Composition Results from DESTINY PWS, a Phase III Trial of DCCR in Prader-Willi Syndrome soleno.life ↗
Significant reductions in fat mass (p=0.0027) were observed after 13 weeks of double-blind treatment |
| 2020-09-30 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Updated 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, measured by the total score of a Hyperphagia Questionnaire for Clinical Trials (HQ-CT, 036). |
| 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. |
| 2020-04-23 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Publication Evaluating Potential Role of Activating ATP-Sensitive Potassium Channel in Treatment of Hyperphagic Obesity soleno.life ↗
These responses have also been seen in diazoxide chloride-controlled release (DCCR)-treated patients with PWS, a rare genetic form of hyperphagic obesity. |
| 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. |
| 2018-10-08 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Presents Clinical Data on DCCR at 2018 Foundation for Prader-Willi Research Annual Conference soleno.life ↗
The data presented on DCCR at this year’s FPWR continue to support the design of our ongoing Phase 3 trial, |
| 2018-10-01 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Presents Clinical Data on DCCR at Late-Breaking Session of European Society for Paediatric Endocrinology soleno.life ↗ |
| 2018-07-30 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Receives Fast Track Designation from FDA for DCCR for Treatment of Prader-Willi Syndrome soleno.life ↗ |
| 2017-11-14 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2017 Financial Results soleno.life ↗
Presented Positive Updated Safety and Efficacy Data from Pilot Clinical Trial of DCCR for Treatment of Prader-Willi Syndrome |
| 2017-10-12 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Receives Positive Opinion from European Orphan Committee for DCCR in Prader-Willi Syndrome soleno.life ↗
Soleno Therapeutics, Inc. (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending Diazoxide Choline Controlled-Release Tablet (DCCR) for designation as an orphan medicinal product for the treatment of Prader-Willi Syndrome (PWS). |
| 2017-09-25 | Soleno Therapeutics, Inc. | Regulatory Soleno Therapeutics Announces Receipt of Scientific Advice from the European Medicines Agency for DCCR in Prader-Willi Syndrome soleno.life ↗
The EMA indicated that a single pivotal trial would support a Marketing Authorisation Application. |
| 2017-09-15 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Presents Updated Safety and Efficacy Data from Clinical Trial of DCCR for Treatment of Prader-Willi Syndrome soleno.life ↗
Soleno Therapeutics, Inc. (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced today that updated safety and efficacy data from the pilot clinical trial of Diazoxide Choline Controlled Release Tablet (DCCR) for the treatment of Prader-Willi syndrome (PWS) were the subject of a poster presentation at the 10 th International Meeting of Pediatric Endocrinology, being held September 14-17 in Washington , D.C. |
All press releases naming this drug 65 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DCCR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03714373 ↗ |
| Known as | Diazoxide choline extended-release tablet | “Diazoxide choline extended-release tablet in people with Prader-Willi syndrome: results from long-term open-label study.” PMID 37919617 ↗ Nov 2023 |
| Route | Oral | “Once daily oral administration of open-label DCCR tablet(s) during the OLE Period” NCT03714373 ↗ |