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Sincalide | CAS No: 25126-32-3 | GMP-certified suppliers
A medication that enhances gallbladder contraction, stimulates pancreatic secretion, and accelerates small bowel transit for diagnostic imaging and functional assessment of the gastrointestinal system.
Therapeutic categories
Primary indications
- 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
Product Snapshot
- Sincalide is an injectable peptide formulated as a lyophilized powder for intravenous solution
- It is primarily used for diagnostic stimulation of gallbladder contraction, pancreatic secretion analysis, and acceleration of small bowel transit during imaging procedures
- Sincalide (Kinevac) is approved for use in the US and Canadian markets
Clinical Overview
Clinically, sincalide is approved for use under the brand name Kinevac in the United States. It is employed to stimulate gallbladder contraction, enabling imaging procedures to assess gallbladder emptying and biliary tract patency. It also facilitates collection of concentrated bile via duodenal aspiration for analysis of cholesterol, bile salts, phospholipids, and crystals. Additionally, sincalide stimulates pancreatic secretion in combination with secretin to aid enzyme activity and cytological studies of pancreatic function. Sincalide is used to accelerate small bowel transit during fluoroscopic evaluation with barium meals, thereby reducing examination time and radiation exposure.
Pharmacodynamically, an intravenous bolus dose of 0.02 mcg/kg sincalide induces maximal gallbladder contraction within 5 to 15 minutes. Gallbladder size typically decreases by at least 40%, representing satisfactory functional contraction. Its mechanism of action reflects the physiological role of endogenous cholecystokinin: sincalide binds to CCK receptors on gallbladder smooth muscle, prompting contraction and consequent bile evacuation. Concurrently, it stimulates pancreatic acinar cells to secrete digestive enzymes and ductal cells to release bicarbonate. When combined with secretin, the volume and bicarbonate content of pancreatic secretions are enhanced, supporting detailed pancreatic function analysis.
Regarding absorption, distribution, metabolism, and excretion (ADME), sincalide acts locally and systemically following intravenous administration. Given its peptide nature, it is rapidly degraded enzymatically and exhibits minimal systemic accumulation. Its elimination primarily involves renal clearance of peptide fragments.
Safety considerations include potential adverse reactions such as nausea, abdominal discomfort, flushing, or allergic responses. Caution is advised in patients with known hypersensitivity to cholecystokinin analogs or severe cardiopulmonary disease. Appropriate dosing and monitoring are essential to minimize adverse effects.
From an API sourcing perspective, sincalide production requires stringent control over peptide synthesis purity, sequence fidelity, and stability due to its peptide nature and clinical diagnostic use. Reliable suppliers should provide documentation on quality attributes including identity, potency, microbial limits, and endotoxin levels in compliance with regulatory standards to ensure consistent performance in diagnostic applications.
Identification & chemistry
| Generic name | Sincalide |
|---|---|
| Molecule type | Biotech |
| CAS | 25126-32-3 |
| UNII | M03GIQ7Z6P |
| DrugBank ID | DB09142 |
Pharmacology
| Summary | Sincalide is a cholecystokinin analog that targets CCK type A and B receptors to induce gallbladder contraction and stimulate pancreatic secretions. Its pharmacological effects replicate endogenous cholecystokinin, promoting bile evacuation and enhancing pancreatic enzyme and bicarbonate output when combined with secretin. This activity facilitates diagnostic procedures by enabling assessment of gallbladder function and pancreatic enzyme analysis. |
|---|---|
| Mechanism of action | 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. Like cholecystokinin, sincalide stimulates pancreatic secretion; concurrent administration with secretin increases both the volume of pancreatic secretion and the output of bicarbonate and protein (enzymes) by the gland. This combined effect of secretin and sincalide permits the assessment of specific pancreatic function through measurement and analysis of the duodenal aspirate. |
| Pharmacodynamics | Following an intravenous (bolus) injection of 0.02 mcg/kg of sincalide, maximal contraction of the gallbladder occurred in 5 to 15 minutes. Sincalide reduced gallbladder radiographic size by at least 40%, generally considered satisfactory contraction. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cholecystokinin receptor type A | Humans | agonist |
| Gastrin/cholecystokinin type B receptor | Humans | agonist |
ADME / PK
| Absorption | The intravenous (bolus) administration of sincalide causes a prompt contraction of the gallbladder that becomes maximal in 5 to 15 minutes, as compared with the stimulus of a fatty meal which causes a progressive contraction that becomes maximal after approximately 40 minutes. |
|---|---|
| Half-life | Limited information is available on the half-life of sincalide. |
| Protein binding | Limited information is available on the protein binding of sincalide. |
| Metabolism | Limited information is available on the metabolism of sincalide. |
| Route of elimination | Limited information is available on the route of elimination of sincalide |
| Volume of distribution | Limited information is available on the volume of distribution of sincalide. |
Formulation & handling
- Sincalide is a biotech peptide available as a lyophilized powder formulated for intravenous injection.
- The product requires reconstitution prior to intravenous administration, necessitating aseptic handling techniques.
- Storage and handling should account for peptide stability, typically involving refrigeration and protection from light until use.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is marketed in the US and Canada, with initial patent protection expiring in the US in August 2022 and extended patents valid through April 2038, indicating a mature market with ongoing patent coverage. |
|---|
| Markets | US, Canada |
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Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Sincalide involves a limited number of originator companies, with branded products primarily present in the US and Canadian markets. Multiple active patents in the United States extend protection through 2038, indicating limited current generic competition and a protected market position in the near term. |
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Safety
| Toxicity | Based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous abortion. 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. 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. |
|---|
- Sincalide may induce vagal-mediated cardiovascular effects, including hypotension, bradycardia, syncope, and ECG changes at doses exceeding therapeutic levels
- Exposure during pregnancy has shown no teratogenic effects in animal studies at doses up to clinically relevant levels
- However, high-dose prenatal exposure was associated with developmental delays in rats
Sincalide is a type of Diagnostic agents
Diagnostic agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used in the field of medical diagnostics. These agents play a vital role in diagnosing various diseases and conditions by aiding in the visualization and identification of specific biomarkers or structures within the body.
Diagnostic agents encompass a wide range of substances, including contrast agents, radiopharmaceuticals, and imaging agents. Contrast agents are commonly used in medical imaging techniques such as X-rays, magnetic resonance imaging (MRI), and computed tomography (CT) scans. They enhance the visibility of certain tissues or organs, allowing healthcare professionals to detect abnormalities more accurately.
Radiopharmaceuticals are another type of diagnostic agent that combines a radioactive component with a pharmaceutical compound. These agents emit radiation that can be detected by specialized imaging equipment, enabling the visualization of metabolic processes and the identification of abnormal cellular activity.
Imaging agents are designed to target specific molecular structures or biomarkers within the body. They can be used to detect and visualize specific proteins, enzymes, or receptors associated with certain diseases or conditions. By targeting these specific biomarkers, imaging agents provide valuable information about the presence, location, and extent of a disease, aiding in diagnosis and treatment planning.
Overall, diagnostic agents are essential tools in modern medicine, facilitating accurate and timely diagnoses. These pharmaceutical APIs enable healthcare professionals to identify and monitor diseases at an early stage, leading to better patient outcomes and improved treatment strategies.
Sincalide API manufacturers & distributors
Compare qualified Sincalide API suppliers worldwide. We currently have 1 companies offering Sincalide API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
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