Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Sincalide (Kinevac, CCK-8): what the evidence says

Name: Sincalide (Kinevac, CCK-8)
Published: 2026-10-27

At a glance

What it is: a synthetic copy of the last 8 amino acids of cholecystokinin (CCK-8), the gut hormone that makes the gallbladder contract and the pancreas secrete. Approved as Kinevac (Jul 1976) as a diagnostic aid: to contract the gallbladder during imaging, to collect bile or pancreatic fluid (with secretin), and to speed barium through the small bowel. ^{R1, R2}

What the evidence says: Human a 4-center study of 60 healthy volunteers set normal values for gallbladder emptying during sincalide-stimulated scans. ^R3 Whether a low result reliably predicts benefit from gallbladder surgery is still debated, and experts have called for a large randomized trial. ^R4

Biggest risks: serious allergic reactions including anaphylaxis (the product contains a sulfite); it can push small gallstones into the bile ducts, and fast injection causes nausea, cramping and flushing. Pregnant women should be told of a risk of preterm labor or miscarriage. ^R2

Rating


Human Human evidence	Moderate: multicenter normal-value study and reviews ^{R3, R4}
Animal Animal / lab evidence	Not reviewed
Regulatory	FDA-approved diagnostic ^{R1, R5} · not on FDA's 503A list; on the 503B list in Category 1 (under evaluation) ^{R6, R7} · not on FDA's safety-risk page ^R8 · not named by WADA ^R9
Established human dose	Yes, label dose (see Study details)

Evidence verdict: Gallbladder and pancreas function testing: Moderate (long-approved diagnostic; normal values set in a multicenter study, but predictive value of the test is debated) · Weight loss or appetite control: No human data reviewed

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: the drug reliably contracts the gallbladder; the open question is how well the test result guides treatment.

What is it?

Related pages: secretin.

Does it work?

Human Ziessman 2010 (60 volunteers, 4 centers): the slowest infusion gave the least variable results and set a lower limit of normal for gallbladder ejection fraction. ^R3
🟨 Clinical utility: reviews note mixed evidence that a low ejection fraction predicts relief after gallbladder removal. ^R4
⚪ Weight loss or appetite: no human data reviewed for this product.

Is it safe?

Contraindicated with sulfite or sincalide allergy, and with bowel obstruction. ^R2
Warnings: anaphylaxis, gallstone evacuation, GI reactions with fast IV injection, preterm labor or spontaneous abortion. ^R2

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: FDA-approved, prescription diagnostic (Kinevac; a second sincalide product approved in Nov 2022). ^{R1, R5}
Compounding: sincalide is in Category 1 (under evaluation) on FDA's 503B bulk-substance list, marked as a component of an FDA-approved drug; it is not on the 503A list or FDA's compounding safety-risk page. ^{R6, R7, R8}
Sport: not named on WADA's 2026 Prohibited List. ^R9

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
Ziessman 2010	60 healthy volunteers, 4 centers	IV infusion	0.02 µg/kg over 15, 30 or 60 min	Single tests	60-min infusion least variable; lower limit of normal GBEF 38%	PMID 20080900
Kinevac label	Adults	IV	Per label	Diagnostic use	Approved diagnostic indications	^R2

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)

^R1 Drugs@FDA, Kinevac (sincalide), application NDA017697 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA017697
^R2 Kinevac prescribing information, label published Oct 20, 2023 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1408aabb-6982-48e5-ae9f-504ec43b0003
^R3 Ziessman HA, et al. J Nucl Med. 2010. PMID 20080900
^R4 Ziessman HA. Semin Nucl Med. 2012. PMID 22293163
^R5 Drugs@FDA, Sincalide (Maia), application NDA210850 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA210850
^R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download Sincalide appears in Category 1 (under evaluation), marked as a component of an FDA-approved drug.
^R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R9 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Sincalide (Kinevac, CCK-8). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).