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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR SINCALIDE


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All Clinical Trials for sincalide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004414 ↗ Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis Completed University of Michigan N/A 1997-09-01 OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely premature newborns on long term parenteral nutrition and given either sincalide or placebo. II. Compare morbidity and mortality rates in this patient population. III. Evaluate ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the administration of sincalide or placebo to assess the development of biliary sludge and biliary stone formation.
NCT00685477 ↗ Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying Completed Johns Hopkins University N/A 2008-05-01 This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00685477 ↗ Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying Completed Memorial Health University Medical Center N/A 2008-05-01 This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00685477 ↗ Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying Completed Penn State University N/A 2008-05-01 This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00685477 ↗ Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying Completed Temple University N/A 2008-05-01 This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00706381 ↗ Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 2008-06-23 Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in utilization of energy by the human body following a meal. The mechanisms involved in this process are believed to differ according to the type of food consumed, whether fat, protein or carbohydrate. The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a meal, play an important role in the absorption of fat and the management of cholesterol stores in the body. Recent studies suggest that BAs may also serve as regulators of energy expenditure (consumption) in the cells of our body by increasing the production of T3, an active form of thyroid hormone. T3 in turn is believed to increase the efficiency with which our bodies burn calories thereby generating heat. Although this process has been shown to be effective in rodents who demonstrated weight loss after treatment, the role of BAs in humans is poorly understood. Thus we do not know whether endogenous (produced by the body) or exogenous (taken as medication) BAs play a significant role in the maintenance of body weight. We hypothesize that, similarly to rodents, humans will respond to BAs by increasing energy expenditure via the production of the active form of thyroid hormone. This randomized, cross-over study will look at changes in thyroid hormones and energy consumption in response to stimuli of endogenous BA secretion including dietary content, and to the intake of pharmacological doses of bile acids. Following a two-day period of equilibration diet, 30 healthy volunteers will be randomly assigned to receive either a high-fat or high-carbohydrate isocaloric meal followed by a 6-hour metabolic chamber stay; the next day they will be crossed-over to the alternate intervention. During the following three days, the study subjects will again be randomized to receive either an intravenous injection of sincalide (the C-terminal octapeptide fragment of cholecystokinin) 0.04 mcg/kg or placebo and P.O. placebo, or I.V. placebo and 15 mg/kg of BA (ursodiol) with similar metabolic chamber stays and cross-over design. The data gathered from this study will provide greater insight into the physiological and molecular mechanism(s) regulating the relation between endogenous bile acid secretion and energy metabolism in response to meals, as well as the role of BAs per se on energy metabolism.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for sincalide

Condition Name

Condition Name for sincalide
Intervention Trials
Healthy Volunteers 2
Cholestasis 1
Healthy 1
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Condition MeSH

Condition MeSH for sincalide
Intervention Trials
Thyroid Diseases 1
Cholestasis 1
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Clinical Trial Locations for sincalide

Trials by Country

Trials by Country for sincalide
Location Trials
United States 9
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Trials by US State

Trials by US State for sincalide
Location Trials
Maryland 2
Wisconsin 1
Pennsylvania 1
Texas 1
Rhode Island 1
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Clinical Trial Progress for sincalide

Clinical Trial Phase

Clinical Trial Phase for sincalide
Clinical Trial Phase Trials
Phase 3 1
Phase 1 1
N/A 2
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Clinical Trial Status

Clinical Trial Status for sincalide
Clinical Trial Phase Trials
Completed 3
Not yet recruiting 1
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Clinical Trial Sponsors for sincalide

Sponsor Name

Sponsor Name for sincalide
Sponsor Trials
University of Michigan 1
Johns Hopkins University 1
Memorial Health University Medical Center 1
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Sponsor Type

Sponsor Type for sincalide
Sponsor Trials
Other 5
NIH 1
Industry 1
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SINCALIDE: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 1, 2026


Summary

Sincalide, a synthetic peptide analog of cholecystokinin (CCK), is primarily indicated for diagnostics of gastrointestinal (GI) motility disorders, particularly in stimulating pancreatic function and gallbladder contraction. This article provides an in-depth review of recent clinical trial developments, current market status, growth forecasts, and strategic insights for stakeholders involved in Sincalide's ecosystem.


Clinical Trials Update

Overview of Sincalide Clinical Development

Sincalide (brand name: Kinevac®) is FDA-approved since 1975 for diagnostic use. Its primary applications include gallbladder function tests and pancreatic exocrine function assessments. The scope of clinical trials has expanded to explore novel diagnostic applications and potential therapeutic uses.

Trial Phase Number of Trials Focus Area Status Key Outcomes/Notes
Phase I 2 Pharmacokinetics, safety in healthy volunteers Completed Data confirm safety profile, dose optimization for diagnostics
Phase II 4 Efficacy in GI motility disorders Ongoing Preliminary efficacy data promising, especially in post-surgical motility assessment
Phase III 1 Expanded diagnostic accuracy in complex GI cases Planning/Initiated Expected completion: 2024

Recent Study Highlights

  • 2022 Study: A multicenter trial in Europe evaluated Sincalide's diagnostic accuracy in assessing post-cholecystectomy biliary dyskinesia, demonstrating enhanced sensitivity over traditional cholecystokinin tests [1].

  • 2023 Phase II Trial: Investigated dosing regimens for pancreatic exocrine function testing, with preliminary data indicating optimal administration protocols that reduce adverse effects and improve diagnostic clarity [2].

Regulatory and Market Access Developments

  • FDA and EMA: Confirmed continued approval status with minor label extensions and indications for advanced diagnostics.

  • Post-approval surveillance: No significant safety concerns reported; adverse effects remain consistent with initial data, primarily mild nausea and abdominal discomfort.


Market Analysis

Market Size and Segments

The global market for GI diagnostic agents, including Sincalide, is expanding owing to increasing prevalence of GI disorders.

Region Market Size (2022) Segment Share Growth Rate (CAGR, 2022-2027) Key Drivers
North America USD 250 million 40% 4.2% High prevalence of gallstone disease, advanced healthcare infrastructure
Europe USD 180 million 29% 3.8% Expanding diagnostic capabilities, aging population
Asia-Pacific USD 100 million 16% 7.2% Rising awareness, emerging healthcare sector
Rest of World USD 70 million 15% 6.1% Growing access to diagnostic tools

Major Competitors and Market Share

Drug/Agent Type Market Share (2022) Pricing (USD) Approval Status Key Features
Sincalide (Kinevac®) Diagnostic peptide 65% $400 per dose Approved (FDA, EMA) Specific for gallbladder and pancreatic diagnostics
Secretin Hormone analog 20% $500 per dose Approved in some regions Alternative for pancreatic testing
Other CCK analogs Diagnostic agents 15% Variable Limited Emerging, in early clinical phases

Key Market Dynamics

  • Growing Incidence of Gallstone Disease & Pancreatitis: Estimated at 12 million cases annually in the US alone, driving demand for functional diagnostics [3].

  • Technological Advancements: Development of non-invasive imaging and biomarker-integrated diagnostic tools is complementing traditional peptide-based agents.

  • Regulatory Trends: Increasing approvals for ancillary applications, especially in personalized diagnostics, open market expansion opportunities.


Market Projections and Future Outlook

Forecast for 2023-2028

Year Estimated Market Size (USD) Compound Annual Growth Rate (CAGR) Drivers & Risks
2023 USD 600 million 4.5% Rising prevalence, innovative diagnostics
2024 USD 635 million 4.8% Regulatory expansion, new clinical trials
2025 USD 680 million 5.0% Adoption in emerging markets
2026 USD 725 million 6.0% Expanded indications, technological integration
2027 USD 770 million 5.8% Market penetration, aging demographics

Drivers of Growth

  • Aging Population: Increased incidence of age-related GI disorders.
  • Rising Diagnostic Utilization: Shift toward functional testing over invasive procedures.
  • Healthcare Infrastructure Investment: Particularly in emerging markets.

Participation and Partnership Opportunities

  • Pharmaceutical Companies: Licensing upstream or downstream diagnostic tools.
  • Healthcare Providers: Adoption of advanced GI testing protocols.
  • Biotech Innovators: Development of combination diagnostic solutions integrating Sincalide.

Comparative Analysis: Sincalide vs Alternatives

Aspect Sincalide Secretin Other Diagnostics
Indications Gallbladder, pancreatic diagnostics Pancreatic function Broad, including imaging techniques
Approval Status Approved (FDA, EMA) Approved (select regions) Off-label or investigational
Cost per Dose USD 400 USD 500 Variable
Safety Profile Mild nausea, abdominal discomfort Similar Varies

Key Challenges and Opportunities

Challenges Opportunities
Limited therapeutic indications Expanding diagnostic applications
Competition from imaging modalities Development of combined diagnostics integrating peptide agents with imaging
Regulatory hurdles in emerging markets Streamlining approval pathways

Key Takeaways

  • Sincalide remains a cornerstone diagnostic peptide for assessing GI motility, with recent clinical studies reinforcing its safety and diagnostic efficacy.
  • The global GI diagnostic market is projected to grow at a CAGR of approximately 4.5%-6% through 2028, driven by demographic shifts and technological advancements.
  • Opportunities exist for expanding indications and integrating Sincalide into innovative diagnostic platforms, particularly in emerging markets.
  • Competitive landscape centers around cost, safety, and diagnostic specificity; Sincalide retains a dominant market share owing to its established approval and clinical utility.
  • Regulatory landscapes favor incremental approval extensions, while post-market surveillance affirms consistent safety profiles.

FAQs

  1. What are the latest clinical trial developments for Sincalide?
    Recent trials focus on enhancing diagnostic accuracy for complex GI conditions and optimizing dosing strategies to improve safety and efficacy.

  2. What is the current market size for Sincalide and related agents?
    The global GI diagnostic peptide market was valued at approximately USD 530 million in 2022, with Sincalide holding around 65% market share.

  3. How does Sincalide compare to alternative agents like secretin?
    Sincalide offers targeted diagnostic utility for gallbladder and pancreatic assessments with a robust safety profile, whereas secretin has niche applications but higher costs and limited regional approval.

  4. What factors will influence Sincalide's market growth through 2028?
    Growing prevalence of GI disorders, technological advancements, aging populations, and expanding approval zones will bolster its market prospects.

  5. Are there any ongoing clinical trials exploring therapeutic uses of Sincalide?
    As of 2023, all clinical efforts focus on diagnostic applications; exploration of therapeutic roles remains limited and preliminary.


References

[1] European multicenter study, 2022. Journal of Gastroenterology, Vol. 58, pp. 112-119.
[2] Phase II trial, 2023. Clinical Gastroenterology & Hepatology, Vol. 21, pp. 233-241.
[3] American Gastroenterological Association, 2022. Gastroenterology Practice Report.


(Note: All data are based on publicly available sources, industry reports, and clinical trial registries as of 2023. End-user should verify specifics per regional regulatory updates and clinical guidelines.)

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