Vykat Xr

(Diazoxide choline)

Small molecule

SSoleno Therapeutics, Inc.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Hypertriglyceridemia2 trials

Diazoxide Choline in Hypertriglyceridemia

Completed·EEssentialis, Inc.·Phase 2·NCT00696475·80 enrolled

Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

Completed·EEssentialis, Inc.·Phase 2·NCT01211847·44 enrolled

TED1 trial

Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations

Completed·EEssentialis, Inc.·Phase 1·NCT00688857·12 enrolled

Treatment1 trial

A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)

Unknown status·EEssentialis, Inc.·Phase 2·NCT02893618·32 enrolled

Prader-Willi syndrome1 trial

An Observational Study of VYKAT™ XR (Diazoxide Choline Extended-Release Tablets) in Patients With Prader-Willi Syndrome (PWS)

Enrolling by invitation·SSoleno Therapeutics, Inc.··NCT07450664·200 enrolled

Unspecified2 trials

Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

Withdrawn·EEssentialis, Inc.·Phase 1·NCT00901823

Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

Completed·EEssentialis, Inc.·Phase 1·NCT01211860·9 enrolled

Regulatory

FDA Approval Timeline[3]

Mar 26, 2025

VYKAT XR

NDA NDA216665

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Diazoxide choline. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Diazoxide choline compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA216665). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Vykat Xr. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Soleno Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: SSoleno Therapeutics, Inc.

Patent Landscape[4]

Patent Cliff

Dec 20, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7572789Dec 20, 2026

7799777Mar 5, 2029

12343348Nov 12, 2035

12178823Nov 12, 2035

9757384Nov 12, 2035

1 more patents

12419895Nov 12, 2035