Drugs / Diazoxide Choline
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Prader-Willi syndrome due to paternal deletion of 15q11q13 type 2 1 milestone | |||||
| Filed | US (FDA) | — | Prader-Willi syndrome due to paternal deletion of 15q11q13 type 2 | 2024-08-07 | “Submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Diazoxide Choline Extended-Release (DCCR) for the treatment of Prader-Willi Syndrome (PWS)” soleno.life ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | VYKAT XR | — | 2025-03-26 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT00901823 | Mar 2011 | hypertriglyceridemia | Essentialis, Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT01211860 | Oct → Nov 2010 | hypertriglyceridemia | Essentialis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00688857 | May → Jun 2008 | hypertriglyceridemia | Essentialis, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01211847 | Oct 2010 → Sep 2011 | hyperlipidemia, hypertriglyceridemia | Essentialis, Inc. | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05701774 | Jan 2023 → Jun 2028 expected | Prader-Willi syndrome | Soleno Therapeutics, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT03440814 | May 2018 → May 2020 | Prader-Willi syndrome | Soleno Therapeutics, Inc. | Completed | Missed primary |
| Phase 3 | NCT00973271 | Mar → Nov 2011 | hypertriglyceridemia | Essentialis, Inc. | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 34
| 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 ↗
The validation of our MAA represents the next significant milestone in our mission to deliver this important therapy to the broad PWS community, including those in the EU, |
| 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 ↗ |
| 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 ↗ |
| 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 |
| 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 ↗
today announced that 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. |
| 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 ↗
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. |
| 2024-05-22 | Soleno Therapeutics, Inc. | Results Soleno Therapeutics Announces Oral Presentation featuring DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome at ENDO 2024 soleno.life ↗
Withdrawal of DCCR (Diazoxide Choline) Extended-Release Tablets Worsens Hyperphagia and Increases Weight and BMI in a 16-week Double-blind, Placebo-controlled, Randomized Withdrawal Period in Patients with Prader Willi Syndrome |
| 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 ↗
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 ↗
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 Breakthrough Therapy Designation to diazoxide choline for the treatment of adults and children ages 4 years and older with genetically confirmed Prader-Willi syndrome (PWS) who have hyperphagia. |
| 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 ↗
One-Year Administration of DCCR in PWS Patients from DESTINY-PWS Demonstrates Significant Improvements in Hyperphagia and Other Behavioral Complications |
| 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 ↗
Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced positive top-line results 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). |
| 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 ↗
Highly statistically significant reductions in HQ-CT total score for C601/C602 compared to the matched PfPWS cohort at Week 26 for propensity-adjusted and non-propensity-adjusted analyses and were sustained at Week 52 (all p<0.001) |
| 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 ↗
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 ↗
Results Show Improvement in Multiple Behavioral Domains Following Treatment with DCCR |
| 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 ↗
Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that updated top-line results from the Company’s Phase III trial, DESTINY PWS (C601), evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS), were highlighted in an oral presentation by Jennifer L. Miller , M.D., Professor in the Division of Pediatric Endocrinology at the University of Florida , at the Foundation for Prader-Willi Research Annual Research Symposium . |
| 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. |
| 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 ↗
These results indicate that DCCR targets the underlying neural mechanisms of hyperphagia in PWS. |
| 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 ↗
We are also encouraged by the data from these studies demonstrating that treatment with DCCR is not associated with compromised glycemic control. |
| 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 ↗
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 Fast Track designation to Diazoxide Choline Controlled-Release (DCCR) for the treatment of Prader-Willi Syndrome (PWS). |
| 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). |
| 2017-09-15 | 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 ↗
Thirteen subjects were enrolled; 11 subjects completed the open-label phase, were classified as responders and randomized into the double-blind phase. |
All press releases naming this drug 35 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Diazoxide choline | “Diazoxide choline extended-release tablet in people with Prader-Willi syndrome: results from long-term open-label study.” PMID 37919617 ↗ Nov 20236“An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome” NCT05701774 ↗ “290 mg diazoxide choline” NCT00973271 ↗ |
| Known as | DCCR | “Diazoxide choline extended-release (DCCR) tablets have previously been evaluated for their effects on hyperphagia and other behavioral complications of people with PWS” PMID 38671361 ↗ Apr 20245“A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels” NCT01211860 ↗ “An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome” NCT05701774 ↗ “Diazoxide Choline Controlled-Release Tablet (DCCR)” NCT00901823 ↗ “Diazoxide Choline Controlled-Release Tablet (DCCR)” NCT00973271 ↗ “DCCR Treatment with 290 mg Diazoxide Choline” NCT01211847 ↗ |
| Route | Oral | “administered orally once daily” NCT00688857 ↗ |