Vykat Xr

(Diazoxide choline)

Phase 2Small molecule

SSoleno Therapeutics, Inc.

Vykat Xr is one of 45 small molecule programs targeting Hypertriglyceridemia. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HypertriglyceridemiaActive, not recruiting

HypertriglyceridemiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

63 competitors in Hypertriglyceridemia

#DrugCompanyPhaseTrials

Selzentry

Lopid

Cipro

Lovaza

3 5

Zocor

Topamax

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

1 8

Zetia

Statin

1 10

EVKEEZA

Regeneron

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

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

Unspecified2 trials

Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

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

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

Withdrawn·EEssentialis, Inc.·Phase 1·NCT00901823

Regulatory

FDA Approval Timeline[4]

Mar 26, 2025

VYKAT XR

NDA NDA216665

Sources

References

[1]
ClinicalTrials.gov — 6 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]
Open Targets Platform — Drug–disease associations for Diazoxide choline. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216665). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vykat Xr. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Soleno Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SSoleno Therapeutics, Inc.

Patent Landscape[5]

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

Vykat Xr

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Hypertriglyceridemia2 trials

TED1 trial

Treatment1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News