Digestive & weight Cholecystokinin analog
Sincalide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- Also known as
- Kinevac
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Sincalide (sold as Kinevac) is a synthetic fragment of the hormone cholecystokinin used as a diagnostic agent to make the gallbladder contract so its function can be measured. It is given during imaging to calculate the gallbladder ejection fraction and to stimulate pancreatic secretion or speed barium through the small bowel. It has been FDA-approved in the U.S. since 1976 and is given by injection during a diagnostic study.
At a glance
- What it is
- The synthetic C-terminal octapeptide of cholecystokinin (CCK-8), used diagnostically
- Approved for
- Stimulating gallbladder contraction, pancreatic secretion, and small-bowel transit for imaging
- Key fact
- A standardized slow infusion gives the most reproducible gallbladder ejection fraction, with a normal lower limit around 38%
- Route
- Intravenous injection or timed infusion
- Evidence strength
- FDA approved
Summary
Sincalide, sold as Kinevac, is an FDA-approved diagnostic peptide that triggers gallbladder contraction. Learn how it works, its uses, and side effects.
What is sincalide?
Sincalide, sold under the brand Kinevac, is a synthetic copy of the biologically active C-terminal eight amino acids of cholecystokinin (CCK), the gut hormone that signals the gallbladder to empty after a meal. It is used as a diagnostic agent rather than a treatment, to produce a controlled gallbladder contraction (or pancreatic and intestinal response) during imaging. It was approved in the United States in 1976.
How does sincalide work?
Sincalide binds cholecystokinin receptors and reproduces the natural effects of CCK: it makes the gallbladder smooth muscle contract and empty, relaxes the sphincter of Oddi, and stimulates pancreatic enzyme secretion and intestinal motility. In a gallbladder study, sincalide is given during nuclear imaging and the fraction of tracer expelled from the gallbladder, the ejection fraction, is calculated as a measure of gallbladder function.
The way sincalide is administered affects the result: a standardized, slower infusion over about an hour gives the most reproducible ejection fractions, with studies supporting a normal lower limit near 38 percent, whereas rapid injection causes more cramping and less reliable numbers. Sincalide is also used to stimulate pancreatic secretion for sampling and to accelerate the passage of barium through the small intestine during radiologic studies.
Is it FDA-approved?
Editor’s note
Status: Yes. Sincalide (Kinevac) was approved by the FDA in 1976. It is approved to: - Stimulate gallbladder contraction - Stimulate pancreatic secretion (often alongside secretin) - Speed the transit of barium through the small bowel to shorten imaging time
Category: FDA-approved · Primary body area: Digestive & weight
Yes. Sincalide (Kinevac) was approved by the FDA in 1976. It is approved to:
- Stimulate gallbladder contraction
- Stimulate pancreatic secretion (often alongside secretin)
- Speed the transit of barium through the small bowel to shorten imaging time
What is sincalide prescribed for?
Sincalide is used diagnostically to assess gallbladder function through the ejection fraction, to provoke pancreatic secretion for diagnostic sampling, and to shorten small-bowel imaging. It is given by a clinician as part of a specific test.
What are the side effects?
According to the prescribing information, common side effects include:
- Abdominal pain or cramping
- Nausea
- Urge to defecate
- Flushing or dizziness
More serious considerations include:
- Caution in pregnancy, because it may stimulate uterine contraction
Sincalide is contraindicated in intestinal obstruction.
Sources: FDA prescribing information for Kinevac; a multicenter study of standardized sincalide infusion for gallbladder ejection fraction (Ziessman et al., Journal of Nuclear Medicine, 2010, DOI: 10.2967/jnumed.109.069393), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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