Drugs / sincalide

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) KINEVAC 1986-08-25 fda.gov
Approved US (FDA) KINEVAC 1976-07-21 fda.gov

Trials 2 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 31 trial
Phase 3 NCT00706381 Jun 2008 → Aug 2012 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed No outcome recorded
Phase not applicable1 trial
NCT00004414 Sep 1997 → Jun 2002 cholestasis University of Michigan Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04567667 Background Oct 2020 → Apr 2021 Bristol-Myers Squibb Completed No outcome recorded
Phase not applicable1 trial
NCT00685477 Comparator May 2008 → May 2009 Temple University Completed No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as sincalide “This multicenter trial establishes a GBEF lower limit of normal of 38% (first percentile) for a 60-min infusion of 0.02 microg of sincalide per kilogram, quantified at 60 min.” PMID 20080900 Jan 2010
2

NCT00706381

NCT00004414

Known as Cck c-terminal octapeptide ChEMBL registry synonym — accepted as the source's own label CHEMBL1121
Known as CCK-8 “Dose Response of Intravenous Sincalide (CCK-8) for Gallbladder Emptying” NCT00685477
Known as Cck-8s ChEMBL registry synonym — accepted as the source's own label CHEMBL1121
Known as Cholecystokinin c-terminal octapeptide ChEMBL registry synonym — accepted as the source's own label CHEMBL1121
Known as Cholecystokinin Octapeptide “Sincalide (Cholecystokinin Octapeptide) Versus Placebo” NCT00004414
Known as Kinevac ClinicalTrials.gov intervention name — accepted as the source's own label NCT04567667
Known as Sincalida ChEMBL registry synonym — accepted as the source's own label CHEMBL1121
Known as SQ 19844 ChEMBL registry synonym — accepted as the source's own label CHEMBL1121
Action Activate “Cholecystokinin A receptor agonist” CHEMBL1121
Modality Peptide “the C-terminal octapeptide fragment of cholecystokinin” NCT00706381
Route Intravenous “sincalide IV over 10 to 15 minutes” NCT00004414
Target CCKAR “Cholecystokinin A receptor agonist” CHEMBL1121