Sincalide: evidence, FDA status and research

It is a hospital drug that makes the gallbladder squeeze so doctors can see how well it empties. It does this reliably, and a study of 60 people set how to give it.

Sold for

Sincalide is the hospital drug that makes the gallbladder squeeze on cue so radiologists can measure how well it empties.

Studies say

Sincalide reliably contracts the gallbladder and stimulates pancreatic enzyme output, and a 60-person multicenter study standardized how to infuse it for imaging; that is solid for a diagnostic agent but is not outcome-trial evidence.

Why grade B. Sincalide is a diagnostic drug approved in 1976 on physiological studies, not outcome trials. The main modern evidence is a multicenter study of 60 healthy volunteers that compared infusion methods and set normal values for gallbladder ejection fraction. That is enough to establish it does what the label says, but there are no randomized trials showing that sincalide-based testing improves patient outcomes. ¹²

FDA. Sincalide is FDA-approved as Kinevac (approved 1976) as a diagnostic agent: to stimulate gallbladder contraction for imaging, to stimulate pancreatic secretion together with secretin for pancreatic function testing, and to speed the passage of barium through the small bowel during x-ray studies. ²

Written from 2 cited sources. Fact-checked 2026-10-27: 14 claims checked, 5 corrected. Last refreshed 2026-10-27. Not physician reviewed.

What this means for you

What people take it for: Testing how well the gallbladder empties
Can a US doctor prescribe it?: Yes, FDA approved for gallbladder and pancreas tests and X-ray studies.
Properly tested in people?: Partly: some human trials, with gaps. The key study had 60 healthy people.

Evidence checklist

Randomised controlled trial Physiological studies; no outcome trialsno
Human study over 100 people Multicentre study of 60 volunteersyes
More than one research group Multicentre study; in use since 1976yes
Clinical outcomes, not surrogate markers Diagnostic effect, not patient outcomesno
Human safety data beyond case reports Label warnings; decades of diagnostic useyes

Drawn from the cited studies below. A dash means the sources give no information.

What it is

Sincalide is a lab-made copy of the last eight amino acids of cholecystokinin (CCK). CCK is the hormone the small intestine releases after a fatty meal. Those eight amino acids are the active part of the hormone. Squibb developed the drug, and it was approved in 1976. Bracco now sells it as Kinevac. It is a powder that is mixed for injection into a vein. ²

Doctors use it only for diagnosis. The most common use is hepatobiliary scintigraphy. This is a nuclear medicine scan. The liver takes up a radioactive tracer and sends it into the gallbladder. Then the patient gets sincalide, which makes the gallbladder contract. This lets doctors calculate the gallbladder ejection fraction. A low ejection fraction supports a diagnosis of gallbladder dysfunction. It applies to people with biliary-type pain but no stones. ¹²

How it works

Sincalide binds CCK receptors (CCK-A, also called CCK1). These sit on the smooth muscle of the gallbladder wall, which then contracts. They also sit on the sphincter of Oddi, which relaxes. Bile then flows into the duodenum. The same receptors on pancreatic acinar cells trigger release of digestive enzymes. So pancreatic function tests pair sincalide with secretin, which drives fluid and bicarbonate output. Sincalide also makes the small intestine contract more. That is why doctors use it to speed barium through the bowel. Its action starts within minutes and is short. ²

What human research shows

A multicenter study in 60 healthy volunteers at four centers gave each person sincalide over 15, 30 and 60 minutes on separate days. This happened during hepatobiliary scintigraphy. The 60-minute infusion gave the steadiest gallbladder emptying. The coefficient of variation was 19 percent, against 35 percent at 30 minutes and 52 percent at 15 minutes. The study set the lower limit of a normal gallbladder ejection fraction at 38 percent for that method. The authors recommended the 60-minute infusion as the standard for routine use. ¹

The approved uses in the label rest on earlier studies of body function. These showed that sincalide makes the gallbladder contract, which shows on imaging. It increases pancreatic enzyme output when given with secretin. It also shortens the time barium takes to pass through the small bowel. ²

Study	Model	Finding
Multicenter infusion methodology study	Humans, n=60 healthy volunteers, three infusion methods compared	A 60-minute infusion gave the most reproducible gallbladder ejection fraction and set the normal threshold at 38 percent. ¹
Kinevac label clinical pharmacology	Humans, physiological studies supporting the 1976 approval	Sincalide contracts the gallbladder, stimulates pancreatic enzyme secretion with secretin, and speeds barium transit. ²

Safety

The common side effects are the hormone's own actions, felt too strongly. They are abdominal discomfort or pain and nausea, each in at least 20 percent of patients in the label. Patients also get cramping, dizziness and flushing during or soon after injection. The label advises a slow infusion to reduce them. It warns of rare hypersensitivity reactions, including anaphylaxis. It also warns that the drug may cause preterm labor or spontaneous abortion in pregnant women. It is contraindicated in intestinal obstruction. It is a single-dose diagnostic agent, so long-term effects are not a concern. ¹²

Questions for your clinician

Why is this test being ordered, and what will it change?
How fast will it be given, since speed affects cramping?
Is it safe in pregnancy or with bowel obstruction?

Questions people ask

What is sincalide used for?

It has three diagnostic jobs. It contracts the gallbladder during a nuclear medicine scan, to measure how well it empties. It stimulates pancreatic enzyme release during pancreatic function tests, alongside secretin. And it speeds barium through the small intestine during x-ray studies. It does not treat any disease. ²

Why is the injection speed so important?

Shorter infusions gave much less steady gallbladder emptying in healthy people. That makes it harder to tell a normal gallbladder from an abnormal one. In the 60-volunteer multicenter study, variability was 52 percent with a 15-minute infusion and 19 percent with a 60-minute infusion. The authors recommended the 60-minute method as standard. ¹

Is sincalide the same as cholecystokinin?

It is the active tail of the hormone, the last eight amino acids, made in a lab. It does the same things at the gallbladder and pancreas that the full hormone does. ²

What can patients feel during the injection?

Mostly short-lived belly cramping, nausea, flushing and lightheadedness, especially with fast injection. Serious allergic reactions are rare. The label warns pregnant women of a possible risk of preterm labor and miscarriage. ²

Citations

Ziessman 2010, J Nucl Med: multicenter study of sincalide infusion methodology and normal gallbladder ejection fraction values doi.org
Kinevac (sincalide) prescribing information, Bracco, 2023 bracco.com