PeptideTrace
ApprovedCCK Analogue (Diagnostic)Metabolic

Sincalide (Kinevac)

A

Evidence Grade A — Regulatory approved. 104 published studies. 10 registered clinical trials.

10 trials104 studiesUSEUCA

Medically reviewed by a licensed medical professional

Licensed Indications

  • Barium Transit Acceleration
  • Gallbladder Diagnostic Stimulation
  • Pancreatic Secretion Diagnostic Stimulation

User Experience Reports

Loading...

Overview

Sincalide (sold as Kinevac) is not a treatment — it is a diagnostic tool. It is a synthetic version of the active portion of cholecystokinin (CCK), a gut hormone that makes the gallbladder contract. Doctors use it during imaging scans (HIDA scans) to measure how well the gallbladder empties — helping diagnose gallbladder dysfunction in patients with symptoms but no gallstones.

Also Known As

Sincalide is also known by these brand and alternate names:

Research Activity

104studies
Human 83
Animal 12
In-vitro 5
Reviews 13

104 published studies: 83 human, 12 animal, 5 in-vitro, 13 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CANon-prescription (OTC)

Summary

Sincalide is marketed as Kinevac (Bracco Diagnostics, approved approximately 1976). Its primary use is during hepatobiliary scintigraphy (HIDA scans) to assess gallbladder function. It is also used to stimulate pancreatic secretion for collection during diagnostic testing and to accelerate barium transit during small bowel imaging.

Sincalide is one of the longest-established peptide compounds in clinical use and one of the few used purely for diagnostic purposes. Its role in gallbladder ejection fraction testing is well-established, though debate continues about the clinical significance of a low ejection fraction and whether it reliably predicts symptom improvement after gallbladder removal.

Mechanism of Action

After a meal, the gut releases cholecystokinin to signal the gallbladder to contract and release bile into the intestine for fat digestion. Sincalide mimics this signal by activating CCK receptors on the gallbladder muscle, producing a controlled contraction. During a HIDA scan, this allows radiologists to calculate the gallbladder ejection fraction — essentially how much bile the gallbladder can push out. A low ejection fraction (below 35–40%) suggests gallbladder dysfunction and may support a decision for surgery.

Research Summary

Sincalide's role in the gallbladder ejection fraction test during HIDA scans is well established. A low ejection fraction (below 35-40%) suggests the gallbladder is not functioning properly and may support a decision for surgical removal. However, there is ongoing debate about how reliable this test is at predicting which patients will actually feel better after gallbladder surgery — the clinical significance of a low ejection fraction in the absence of gallstones remains contested. No significant research programmes exist for sincalide itself. The broader CCK receptor field remains active in research, with CCK-1 receptor activation explored for appetite control and weight management, though no therapeutics have reached approval through this pathway.

Clinical Trials

PeptideTrace tracks 10 registered clinical trials for Sincalide sourced from ClinicalTrials.gov.

NCT07018804N/AEnrolling by Invitation

Mechanisms and Targeted Therapy of Airway Basal Cell Dysfunction in Bronchiolitis Obliterans Syndrome

Haikou Affiliated Hospital of Central South University Xiangya School of MedicineEndpoint: The self - renewal ability of airway basal cellsCompletion: 2028-06-30
NCT07019519N/ARecruiting

POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS

University of CopenhagenEndpoint: Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR)Completion: 2026-09-30
NCT04567667Phase ICompleted

Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants

Bristol-Myers SquibbEndpoint: Maximum observed plasma concentration (Cmax) of BMS-986278Completion: 2021-04-11
NCT02496221Phase IVCompleted

A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects

GlaxoSmithKlineEndpoint: Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum EffectCompletion: 2015-10-13
NCT02507167Phase ICompleted

Impact of Two Genetic Variants of OATP1B3 or MRP2 or Rifampin on Systemic Disposition and Biological Efficacy of CCK-8

University Medicine GreifswaldEndpoint: CCK-8Completion: 2014-12-01
View all 10 trials on ClinicalTrials.gov →

Regulatory Timeline

1976
Regulatory

FDA ORIG 1

1977
Regulatory

FDA SUPPL 1

1979
Regulatory

FDA SUPPL 4

1985
Regulatory

FDA SUPPL 6

1986
Regulatory

FDA SUPPL 5

1988
Regulatory

FDA SUPPL 9

1992
Regulatory

FDA SUPPL 10

2002
Regulatory

FDA SUPPL 11

2002
Regulatory

FDA SUPPL 14

2002
Regulatory

FDA SUPPL 12

2002
Regulatory

FDA SUPPL 15

2002
Regulatory

FDA SUPPL 13

2005
Regulatory

FDA SUPPL 17

2014
Regulatory

FDA SUPPL 23

2015
Regulatory

FDA SUPPL 24

2015
Regulatory

FDA SUPPL 25

2015
Regulatory

FDA SUPPL 26

2016
Regulatory

FDA SUPPL 27

2018
Regulatory

FDA SUPPL 31

2018
Regulatory

FDA SUPPL 32

2018
Regulatory

FDA SUPPL 33

2022
Regulatory

FDA ORIG 1

2023
Regulatory

Health Canada Market Authorisation

2023
Regulatory

FDA SUPPL 38

2023
Regulatory

FDA SUPPL 4

Scientific Detail

Overview (Scientific)

Sincalide is the synthetic C-terminal octapeptide (8 amino acids) of cholecystokinin (CCK), retaining the biologically active portion of the native 33-amino-acid hormone. It is used exclusively as a diagnostic agent.

Mechanism of Action (Scientific)

Sincalide activates cholecystokinin-A (CCK₁) receptors on gallbladder smooth muscle cells, producing gallbladder contraction and bile ejection into the duodenum. It also stimulates pancreatic enzyme and bicarbonate secretion via CCK₁ receptors on pancreatic acinar and duct cells. There are no therapeutic applications—it is a pharmacological provocation test agent.

Summary (Scientific)

Sincalide is marketed as Kinevac (Bracco Diagnostics, originally approved approximately 1976). Diagnostic indications: (1) gallbladder contraction for hepatobiliary scintigraphy (HIDA scan)—gallbladder ejection fraction (GBEF) calculation, where normal is ≥35–40%; (2) stimulation of pancreatic secretion for collection and analysis; (3) acceleration of barium transit in small bowel follow-through imaging. Administered IV over 30–60 seconds for HIDA scans.

Related Compounds

Linaclotide

Approved
Guanylate Cyclase-C Agonist

Linaclotide is marketed as Linzess (approved August 2012). It is taken as a daily oral capsule on an empty stomach, at least 30 minutes before the first meal. The recommended dose is 290 mcg for IBS-C and 72 or 145 mcg for chronic constipation. In clinical trials, approximately 34% of IBS-C patients met the composite improvement endpoint compared to 17% on placebo. Diarrhoea is the most common side effect (approximately 20%) and the leading reason for discontinuation. Linaclotide has a boxed warning against use in children under 6 years due to deaths in young mice, though no such events have been reported in humans. It competes with plecanatide (which targets the same pathway) and other IBS-C treatments.

Elamipretide

Approved
Mitochondria-Targeted Tetrapeptide (Approved)

Elamipretide (Forzinity) was approved by the FDA for Barth syndrome based on the TAZPOWER trial. The randomised crossover phase (12 patients) did not meet its primary endpoints, but the open-label extension (168 weeks) demonstrated durable improvements in walking distance and muscle strength that formed the basis for approval. Barth syndrome affects approximately 1 in 300,000–400,000 births. A larger Phase III trial in primary mitochondrial myopathy (218 patients, MMPOWER-3) did not meet its primary endpoint, and the drug was not approved for that broader indication. Elamipretide remains approved exclusively for Barth syndrome. See also SS-31 (#158) for the research compound context.

Glucagon

Approved
Counter-Regulatory Peptide Hormone

Glucagon has been available as an emergency injection since the 1960s and remains the standard rescue treatment for severe hypoglycaemia. Recent innovation has focused on making it easier to administer in emergencies. Baqsimi, approved in 2019, was the first needle-free option as a nasal powder. Gvoke, also approved in 2019, eliminated the need to mix and reconstitute the medication before injection — a significant advance since severe hypoglycaemia often impairs the ability to follow complex preparation steps. Dasiglucagon (Zegalogue), a next-generation stable liquid glucagon approved in 2021, further improved on the convenience of rescue administration. Beyond emergency rescue, glucagon's receptor is now a major research target — dual and triple agonists combining glucagon receptor activity with GLP-1 (such as survodutide and retatrutide) are in advanced clinical trials for obesity and metabolic disease.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.