Drugs / Diazoxide Choline
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VYKAT XR | — | 2025-03-26 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| 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| Phase 1 | NCT00901823 | Mar 2011 | hypertriglyceridemia | Essentialis, Inc. | Withdrawn | No outcome recorded |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 | ||||||
| Phase 3 | NCT05701774 | Jan 2023 → Jun 2028 expected | Prader-Willi syndrome | Soleno Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03440814 | May 2018 → May 2020 | Prader-Willi syndrome | Soleno Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00973271 | Mar → Nov 2011 | hypertriglyceridemia | Essentialis, Inc. | Withdrawn | No outcome recorded |
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 ↗ |