Sincalide

When injected intravenously, sincalide stimulates gallbladder contraction and reduction in size. The evacuation of bile that results is similar to that which occurs physiologically in response to endogenous cholecystokinin.

• Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. Kinevac is a cholecystokinin (CCK) analog indicated in adults to: stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals.

• KINEVAC is contraindicated in patients with: a history of hypersensitivity to sulfites or sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] .contraindicated

Recommended Adult Dosage and Administration by Indication: To Stimulate Contraction of the Gallbladder 0.02 mcg/kg as a single dose over 30 to 60 seconds via intravenous injection. If satisfactory contraction does not occur in 15 minutes, administer a dose of 0.04 mcg/kg over 30 to 60 seconds. ( 2.1 ) Alternatively consider an intravenous infusion to reduce gastrointestinal adverse reactions : 0.12 mcg/kg diluted in 100 mL of 0.9% Sodium Chloride Injection USP and infused over 50 minutes at a rate of 2 mL per minute. ( 2.1 , 2.2 , 5.3 ) To Stimulate Pancreatic Secretion in Combination with Secretin 30 minutes after initiation of secretin for injection, administer 0.02 mcg/kg diluted in 30 mL of 0.9% Sodium Chloride Injection USP and infused over 30 minutes at a rate of 1 mL per minute. ( 2.1 , 2.2 ) To Accelerate Transit of a Barium Meal Through the Small Intestine After the barium meal is beyond the proximal jejunum, administer 0.04 mcg/kg over 30 to 60 seconds via intravenous injection. ( 2.1 ) If satisfactory transit of the barium meal has not occurred in 30 minutes, administer a second dose of 0.04 mcg/kg over 30 to 60 seconds. ( 2.1 ) Alternatively consider an intravenous infusion to reduce gastrointestinal adverse reactions : 0.12 mcg/kg diluted in 100 mL 0.9% Sodium Chloride Injection USP and infused over 30 minutes. ( 2.1 , 2.2 , 5.3 ) 2.1 Recommended Dosage and Administration Instructions The recommended dosage and administration of Kinevac by indication is shown in Table 1. For preparation instructions see Dosage and Administration ( 2.2 ) .

Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions : Contains sodium metabisulfite. Serious reactions may occur during or soon after administration. If symptoms occur, discontinue the drug. ( 4 , 5.1 ) Evacuation of Gallstones : Stimulation of gallbladder contraction in patients with small gallbladder stones could lead to the evacuation of the stones from the gallbladder, resulting in their lodging in the cystic duct or in the common bile duct. ( 5.2 ) Gastrointestinal Adverse Reactions with Intravenous Injection : Administration as an intravenous injection may cause transient nausea, vomiting, abdominal pain or cramping, dizziness or flushing. To reduce the risk of adverse reactions when used to stimulate contraction of the gallbladder or accelerate transit of a barium meal through the small intestine, administer as an intravenous infusion over 50 or 30 minutes, respectively. ( 2.1 , 5.3 ) Preterm Labor or Spontaneous Abortion : Advise pregnant women of the potential risk for preterm labor and spontaneous abortion. ( 5.4 , 8.1 ) 5.1 Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions Contains sodium metabisulfite [see Description ( 11 )] , a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

The following clinically significant adverse reactions are described elsewhere in labeling: Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] Evacuation of gallstones [see Warnings and Precautions ( 5.2 )] Adverse reactions with intravenous injection [see Warnings and Precautions ( 5.3 )] Preterm labor or spontaneous abortion [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of Kinevac were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. The most frequent adverse reactions (20% or greater) are gastrointestinal: abdominal discomfort or pain, and nausea; these may not necessarily indicate an abnormality of the biliary tract unless there is other clinical or radiologic evidence of disease. Less common adverse reactions include: Hypersensitivity reactions : anaphylaxis and anaphylactic shock, hypotension, throat tightness, bradycardia, shortness of breath, nausea, abdominal cramping, diaphoresis, hives, rash, itching; and numbness of face, lips and eyes [see Contraindications ( 4 ), ( 5.1 )] . Neurological reactions : seizures, headache. Vasovagal reactions : dizziness, loss of consciousness, nausea, diaphoresis, syncope and hypotension (generally self-limiting). Other: nausea, vomiting, flushing, hypertension, urge to defecate, diarrhea, sneezing.

8.1 Pregnancy Risk Summary Based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous abortion [see Warnings and Precautions ( 5.4 )]. Available data with sincalide for injection are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal embryo-fetal development studies in which sincalide was administered to hamsters and rats during the period of organogenesis, no effects were seen at doses comparable to the maximum recommended clinical dose on a mg/kg basis. However, in a prenatal development study in which rats were administered sincalide during organogenesis through parturition, decreased weight gain and developmental delays were observed at a dose 122 times higher than the maximum recommended human dose based on body surface area. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

In the event of an overdose, symptoms related to vagal stimulation, such as gastrointestinal symptoms (abdominal cramps, nausea, vomiting and diarrhea), hypotension with dizziness or fainting may occur. Overdosage symptoms should be treated symptomatically and should be of short duration. A single bolus intravenous injection of 0.05 mcg/kg (approximately 2 to 3 times the human dose of 0.02 mcg/kg), sincalide caused hypotension and bradycardia in dogs. In addition, higher doses injected intravenously once or repeatedly in dogs caused syncope and ECG changes (approximately 5 times the human dose of 0.02 mcg/kg). These effects were attributed to sincalide-induced vagal stimulation in that all were prevented by pretreatment with atropine or bilateral vagotomy.

• Jul 21, 1976NDANDA017697Bracco
• Nov 22, 2022NDANDA210850Maia Pharms Inc

1. 1Drug Ineffective3825%
2. 2Drug Effect Decreased3523%
3. 3Multiple Use Of Single-use Product2919%
4. 4No Adverse Event2416%
5. 5Nausea138.5%
6. 6Product Quality Issue117.2%
7. 7Therapeutic Product Effect Decreased117.2%
8. 8Diarrhoea85.2%
9. 9Gallbladder Disorder85.2%
10. 10Pain85.2%
11. 11Abdominal Pain74.6%
12. 12Chills74.6%
13. 13Dizziness74.6%
14. 14Hepatobiliary Scan Abnormal74.6%
15. 15Product Physical Consistency Issue74.6%

Recent PubMed references pinned to Sincalide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Elucidation of roles of serine/threonine phosphatases PP1 and PP2A in mediating CCK-stimulated growth and enzyme secretion in pancreatic acinar cells.
  American journal of physiology. Gastrointestinal and liver physiology · 2025 · Ramos-Alvarez I, Jensen RT
  PMID 40375576DOI 10.1152/ajpgi.00308.2024
• Gastrointestinal cholecystokinin signaling pathway drugs modulate osteogenic/cementogenic differentiation of human periodontal ligament stem cells.
  Journal of dentistry · 2025 · Sacramento CM, Casati MZ, Casarin RCV, et al.
  PMID 40032153DOI 10.1016/j.jdent.2025.105657
• [Recombinant porcine interferon-gamma expressed in CHO cells and its antiviral activity].
  Sheng wu gong cheng xue bao = Chinese journal of biotechnology · 2023 · Wang L, Hao R, Yang Y, et al.
  PMID 38147981DOI 10.13345/j.cjb.221000
• CCK-8 enhances acid-sensing ion channel currents in rat primary sensory neurons.
  Neuropharmacology · 2023 · Qin QR, Xu ZQ, Liu TT, et al.
  PMID 37820935DOI 10.1016/j.neuropharm.2023.109739
• Effect of cholecystokinin on small intestinal motility in suncus murinus.
  General and comparative endocrinology · 2023 · Yokota N, Takemi S, Sakata I, et al.
  PMID 37517599DOI 10.1016/j.ygcen.2023.114352
• A potential immunotherapeutic and prognostic biomarker for multiple tumors including glioma: SHOX2.
  Hereditas · 2023 · Wu X, Chen H, You C, et al.
  PMID 37170390DOI 10.1186/s41065-023-00279-8
• Wee1 promotes cell proliferation and imatinib resistance in chronic myeloid leukemia via regulating DNA damage repair dependent on ATM-γH2AX-MDC1.
  Cell communication and signaling : CCS · 2022 · Zeng F, Peng Y, Qin Y, et al.
  PMID 36575478DOI 10.1186/s12964-022-01021-z
• Suppression of PI3Kp110β Reduces Cell Viability and Induces Apoptosis in Human Esophageal Cancer.
  Annals of clinical and laboratory science · 2022 · Pan D, Liao X, Tan S, et al.
  PMID 36197777

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Sincalide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
  Recruiting · Interventional · 30 enrolled · University of Copenhagen
  NCT07019519updated 2025-06-13
• Mechanisms and Targeted Therapy of Airway Basal Cell Dysfunction in Bronchiolitis Obliterans Syndrome
  Enrolling by invitation · Interventional · 5 enrolled · Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
  NCT07018804updated 2025-06-12
• Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants
  Completed · Phase 1 · Interventional · 9 enrolled · Bristol-Myers Squibb
  NCT04567667updated 2022-06-02
• Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)
  Completed · Phase 3 · Interventional · 31 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT00706381updated 2020-07-22
• A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
  Completed · Phase 4 · Interventional · 20 enrolled · GlaxoSmithKline
  NCT02496221updated 2018-04-05
• Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying
  Completed · Interventional · 60 enrolled · Temple University
  NCT00685477updated 2017-02-17
• Impact of Two Genetic Variants of OATP1B3 or MRP2 or Rifampin on Systemic Disposition and Biological Efficacy of CCK-8
  Completed · Phase 1 · Interventional · 19 enrolled · University Medicine Greifswald
  NCT02507167updated 2015-07-23
• The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion
  Completed · Interventional · 10 enrolled · Filip Krag Knop
  NCT01656057updated 2015-07-14
• Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
  Completed · Interventional · 252 enrolled · University of Michigan
  NCT00004414updated 2015-03-25
• Ultrasound for Diagnosis of Biliary Dyskinesia
  Terminated · Interventional · 25 enrolled · Texas Tech University Health Sciences Center
  NCT00737295updated 2010-11-16

Frequently asked questions

How does Sincalide work?

When injected intravenously, sincalide stimulates gallbladder contraction and reduction in size. The evacuation of bile that results is similar to that which occurs physiologically in response to endogenous cholecystokinin.

What is Sincalide used for?

According to FDA labeling, Sincalide carries indications including: Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. Kinevac is a cholecystokinin (CCK) analog indicated in adults to: stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sincalide?

Sincalide is classified as Tests for bile duct patency, Cholecystokinin Analog, Immunologic and Biological Factor Interactions, Bile Secretion Volume Alteration, Decreased Esophageal Muscle Tone, Increased Gallbladder Tone, Inhibition Gastric Mucous Secretion, Stimulation Pancreatic Enzymatic Secretion.

What are the brand names for Sincalide?

Sincalide is marketed under brand names including Kinevac.

What are the contraindications for Sincalide?

Sincalide labeling lists contraindications including: KINEVAC is contraindicated in patients with: a history of hypersensitivity to sulfites or sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] .. Always consult the full prescribing information and a clinician.