PeptideTrace
ApprovedCCK Analogue (Diagnostic)

Sincalide

Kinevac

A

Evidence Grade A — Regulatory approved. 104 published studies. 8 registered clinical trials.

8 trials104 studiesUSEUCA

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.

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

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
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
NCT00706381Phase IIICompleted

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Endpoint: Energy ExpenditureCompletion: 2012-08-21
View all 8 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

Related Compounds

Exenatide

Approved
GLP-1 Receptor Agonist

Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.

Lixisenatide

Approved
GLP-1 Receptor Agonist

Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.

Pramlintide

Approved
Amylin Analogue

Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy. Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.