Sincalide (Kinevac): Uses, Mechanism, and Side Effects

Key takeaways

• Sincalide is an FDA-approved cholecystokinin (CCK) analog marketed as Kinevac, used for diagnostic testing rather than ongoing treatment.
• It stimulates gallbladder contraction, pancreatic secretion, and intestinal motility to support imaging and fluid sampling procedures.
• The label carries no boxed warning.
• Across 13 registered trials, studies have examined gallbladder emptying response and use in neonates at risk for a liver condition tied to intravenous feeding.
• FAERS reports for sincalide are dominated by procedural or product performance issues rather than classic adverse reactions.

What sincalide is

Sincalide is a synthetic peptide that mimics the hormone cholecystokinin (CCK). As a CCK analog, it acts on the same receptors the body's natural hormone uses to trigger digestive responses. When given intravenously, it causes the gallbladder to contract and reduces its size, mirroring the body's normal reaction to a meal. It also stimulates pancreatic secretion and affects intestinal motility, including slowing gastric emptying and prompting pyloric contraction. When paired with the hormone secretin, sincalide increases both the volume of pancreatic secretion and the output of bile.

What sincalide is approved for

Sincalide, sold under the brand name Kinevac, is approved for use in adults for three main diagnostic purposes. It stimulates gallbladder contraction so clinicians can assess gallbladder function through imaging, or so a bile sample can be collected via duodenal aspiration for analysis of cholesterol, bile salts, phospholipids, and crystals. It is also used with secretin to stimulate pancreatic secretion before collecting a duodenal aspirate to evaluate enzyme activity, composition, and cytology. A third use is to speed the movement of a barium meal through the small bowel, which shortens the time and radiation exposure needed for fluoroscopy and x-ray examination of the intestines. The label does not carry a boxed warning.

What the evidence shows

Sincalide has 13 registered clinical trials. A completed study assessed the dose response of intravenous sincalide for gallbladder emptying, helping define how the agent performs in diagnostic use. Another completed trial compared sincalide against placebo in neonates at high risk of developing a liver condition associated with intravenous nutrition. A separate trial examining environmental agents and stress oxidants in female fertility is currently recruiting.

Reported side effects

FAERS reports for sincalide are counts of submitted reports, not confirmed rates of incidence, and they do not establish that the drug caused the event. The most frequently reported issues relate to the diagnostic procedure itself rather than typical drug reactions: drug ineffective (38 reports), decreased drug effect (35), and multiple use of a single-use product (29). A number of reports noted no adverse event at all (24), while others flagged product quality issues (11) or decreased therapeutic effect (11). Gastrointestinal symptoms were reported less often, with nausea (13 reports) and diarrhoea (8) among the more common findings.