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

Patients referred for a gallbladder or pancreatic function test may be given a drug they have never heard of before the procedure. Sincalide is that drug, a diagnostic agent rather than a treatment, designed to make imaging and lab testing more accurate.

Key takeaways

• Sincalide is a cholecystokinin (CCK) analog marketed as Kinevac, used to aid diagnostic procedures rather than to treat disease.
• It works by mimicking the natural hormone CCK, triggering gallbladder contraction and stimulating pancreatic secretion.
• Approved uses include gallbladder imaging support, bile and pancreatic fluid collection for analysis, and speeding barium transit through the small bowel.
• Thirteen registered clinical trials reference sincalide, including completed studies on gallbladder emptying and genetic influences on its disposition.
• FAERS reports are dominated by procedural and product-use issues rather than classic adverse drug effects, alongside some nausea and diarrhoea.

What Sincalide Is

Sincalide belongs to a drug class called cholecystokinin analogs. It is a synthetic version of a hormone the body makes naturally to coordinate digestion. When given intravenously, it causes the gallbladder to contract and shrink, releasing bile much as the body's own cholecystokinin would. It also stimulates the pancreas to secrete digestive fluid, slows gastric emptying, and contracts the pylorus, the valve between the stomach and small intestine. When paired with another hormone called secretin, it further increases the volume and output of pancreatic secretions.

What Sincalide Is Approved For

Under the brand name Kinevac, sincalide is approved for adults for three diagnostic purposes. It is used to stimulate gallbladder contraction so that imaging tests can assess gallbladder function, or so that bile can be collected by duodenal aspiration for analysis of cholesterol, bile salts, phospholipids, and crystals. It is also used alongside secretin to stimulate pancreatic secretion before collecting a duodenal sample for enzyme and cytology analysis. A third approved use is accelerating the passage of a barium meal through the small bowel, which can shorten the time and radiation exposure needed for x-ray and fluoroscopy exams. No boxed warning is listed on the label.

What the Evidence Shows

Thirteen clinical trials in the registry reference sincalide. Among them, a completed Phase 4 study evaluated the effect of albiglutide on gallbladder emptying in healthy subjects, and a completed Phase 1 trial examined how genetic variants affecting drug transport proteins, or rifampin, influence the disposition and biological effect of CCK-8. A separate completed study without a listed phase looked at how gallbladder emptying and bile acids affect GLP-1 secretion in humans. These trials reflect sincalide's role as a research and diagnostic tool, consistent with its approved use.

Reported Side Effects

FAERS data reflect reports submitted to a safety surveillance system, not confirmed incidence or causation. The most frequently reported issues for sincalide relate to its performance as a diagnostic product rather than typical drug reactions: drug ineffective (38 reports), decreased drug effect (35), and multiple use of a single-use product (29). Reports of no adverse event (24) and product quality issues (11) were also common. Among reactions resembling traditional side effects, nausea (13 reports) and diarrhoea (8) were the most noted.