Sincalide

Overview

Sincalide is a medication given by injection to assist in the diagnosis of gallbladder and pancreas disorders. It is identified as the 8-amino acid C-terminal segment of cholecystokinin and is also known as CCK-8. Naturally occurring cholecystokinin is a gastrointestinal peptide hormone normally essential for stimulating protein and fat digestion in the body. When injected intravenously, sincalide produces a substantial reduction in gallbladder size by causing this organ to contract. The evacuation of bile that results is similar to that which occurs physiologically in response to endogenous cholecystokinin. Furthermore, sincalide stimulates the pancreatic secretion of bicarbonate and enzymes. As the product Kinevac (FDA), sincalide is used to stimulate the duodenum, pancreas, and small bowel for cholesterol analysis, enzymatic activity analysis, and x-ray examination respectively.

Indication

As the product Kinevac (FDA), sincalide is used for the following indications: 1) 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; (2) to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; (3) 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.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants	2020/09/28	NCT04567667	Phase 1	Completed	Bristol-Myers Squibb
Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)	2008/06/27	NCT00706381	Phase 3	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis	1999/10/19	NCT00004414	Not Applicable	Completed	University of Michigan

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sincalide	FOSUN PHARMA USA INC	72266-248	INTRAVENOUS	5 ug in 5 mL	12/13/2022
SINCALIDE	Fresenius Kabi USA, LLC	63323-579	INTRAVENOUS	5 ug in 5 mL	1/22/2018
SIncalide	AnazaoHealth Corporation	51808-203	INTRAVENOUS	3 ug in 1 1	6/30/2012
Sincalide	MAIA Pharmaceuticals, Inc.	70511-131	INTRAVENOUS	5 ug in 5 mL	11/1/2023
KINEVAC	Bracco Diagnostics Inc.	0270-0556	INTRAVENOUS	5 ug in 5 mL	1/22/2018

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
KINEVAC 5microgram Powder for injection vial	33388	Bracco Pty Ltd	Medicine	A	11/4/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
KINEVAC PWS INJ 5MCG/VIAL	squibb diagnostics, division of bristol-myers squibb canada inc.	01973754	Powder For Solution - Intravenous	5 MCG / VIAL	12/31/1979
SINCALIDE FOR INJECTION	avir pharma inc.	02494361	Powder For Solution - Intravenous	5 MCG / VIAL	8/3/2023
KINEVAC	E-Z-Em Canada Inc.	02228602	Powder For Solution - Intravenous	5 MCG / VIAL	7/8/1998

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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