Kinevac

(Sincalide)

PreclinicalSmall molecule

UUniversity of Maia

Kinevac is one of 5 small molecule programs targeting Cholestasis. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

CholestasisActive, not recruiting

CholestasisPreclinical

Active, not recruiting

Competition

Competitive Landscape

4 competitors in Cholestasis

#DrugCompanyPhaseTrials

Lynavoy

IIntercept Pharmaceuticals

Phase 3

1 2

IC-Green

PProvepharm SAS

Phase 1

1 3

Tauroursodeoxycholic Acid

HHumanitas Mirasole SpA

Preclinical

1 4

Kinevac

UUniversity of Maia

Preclinical

1 5

Omegaven Emulsion

FFresenius

Preclinical

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

Clinical

Trials by Indication[1]

Homeostasis1 trial

Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00706381·31 enrolled

Cholestasis1 trial

Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis

Completed·UUniversity of Michigan·N/A·NCT00004414·252 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

KINEVAC

NDA NDA017697

Nov 22, 2022

SINCALIDE

NDA NDA210850

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Sincalide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sincalide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sincalide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210850). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Kinevac. U.S. Food & Drug Administration.
[6]
SEC EDGAR — University of Maia company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: UUniversity of Maia

Patent Landscape[5]

Patent Cliff

Apr 20, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11737983Apr 20, 2038

11318100Apr 20, 2038

11110063Apr 20, 2038

Kinevac

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Homeostasis1 trial

Cholestasis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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