CLINICAL TRIALS PROFILE FOR SINCALIDE

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.

Clinical Trial Conditions for sincalide

Condition Name

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

Condition MeSH

Condition MeSH for sincalide
Intervention	Trials
Thyroid Diseases	1
Cholestasis	1

Clinical Trial Locations for sincalide

Trials by Country

Trials by Country for sincalide
Location	Trials
United States	9

Trials by US State

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

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

Clinical Trial Status

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

Clinical Trial Sponsors for sincalide

Sponsor Name

Sponsor Name for sincalide
Sponsor	Trials
Bristol-Myers Squibb	1
University of Michigan	1
Johns Hopkins University	1

Sponsor Type

Sponsor Type for sincalide
Sponsor	Trials
Other	5
NIH	1
Industry	1

Last updated: May 7, 2026

Sincalide (synthetic secretin) — Clinical Trials Update and Market Projection

What is s i n c a l i d e and what is its current clinical footing?

Sincalide is a synthetic form of human secretin used to stimulate pancreatic bicarbonate secretion and to evaluate gallbladder function (classically for biliary dyskinesia) via cholescintigraphy. The active ingredient has been available for decades; the commercial and clinical landscape is driven by maintenance of supply, label positioning in imaging workflows, and periodic updates to payer coverage and protocol standards rather than by large phase-development programs.

Clinical development posture

• No late-stage (Phase 3) registrational trials for s i n c a l i d e are evident in routinely indexed public trial registries at the time of this update.
• Clinical activity is concentrated in:
  • Diagnostic performance studies (protocol comparisons, imaging endpoints).
  • Retrospective or observational analyses in imaging pathways.
  • Safety and handling practices in radiology departments.

Practical implication The “clinical trials update” for s i n c a l i d e is largely operational: studies tend to refine use in imaging protocols rather than expand indications through new pivotal endpoints.

What are the core labeled uses and where does the drug fit in care?

S i n c a l i d e is used in radiology and gastroenterology workflows that require secretin receptor stimulation to support diagnostic imaging interpretations.

Common use patterns

• Gallbladder function assessment by cholescintigraphy after secretin stimulation or related secretin-based protocols.
• Pancreatic function evaluation in contexts where secretin stimulation is part of the diagnostic algorithm.

Operational placement

• Delivered in a controlled clinical setting (typically nuclear medicine).
• Protocolized administration tied to imaging timing windows, radiotracer kinetics, and downstream interpretation.

What does the competitive and regulatory landscape look like?

S i n c a l i d e is a mature, specialty diagnostic drug with a relatively narrow therapeutic field. Competition is primarily through:

• Alternative secretin formulations (where available in-region).
• Imaging protocol alternatives (e.g., other functional tests or different radiotracer strategies).
• Generics or supplier substitutions in markets that support multiple manufacturers.

Regulatory profile

• Mature products with established safety data.
• Ongoing relevance depends on consistent supply and compatibility with nuclear medicine imaging standards.

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Clinical trials update: What does recent evidence emphasize?

Because s i n c a l i d e is not typically the subject of new pivotal trials, the meaningful “update” is the direction of evidence in diagnostic imaging practice, including:

• Standardization of stimulation and imaging time points.
• Clarification of normal ranges and interpretive metrics for gallbladder ejection assessments (where used).
• Safety handling practices across radiology departments (adverse event capture tends to focus on tolerability and reproducibility of imaging response).

Evidence type dominating the literature

• Observational studies and protocol audits.
• Diagnostic accuracy or interpretive reliability work.
• Clinical pathway studies in biliary dyskinesia evaluation.

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Market analysis: demand drivers, constraints, and pricing dynamics

What drives demand for s i n c a l i d e?

Demand follows utilization of secretin-stimulated or secretin-involved imaging pathways.

Key demand drivers

1. Persistent use of functional imaging in biliary and pancreatic diagnostic workups.
2. Hospital and nuclear medicine capacity that sustains demand for stimulation agents.
3. Protocol adherence in gastroenterology and radiology practices that use secretin stimulation to support diagnostic interpretation.

What constrains demand?

1. Diagnostic pathway substitution
   • Where protocols shift toward alternative tests or where payer guidance changes.
2. Specialty supply risk
   • Specialty injectable manufacturing and sourcing constraints can affect availability and elective imaging ordering.
3. Limited payer flexibility
   • Coverage and reimbursement for functional imaging can affect ordering volume.

What does the competitive structure imply for revenue durability?

• Revenue durability is supported by sticky workflow use in imaging departments.
• Revenue volatility can appear when supply disruptions occur or when payer utilization management shifts.

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Market projection: where growth is likely to come from

How should the market be projected given the drug’s mature status?

A mature specialty diagnostic drug typically tracks:

• Imaging volume trends (number of nuclear medicine procedures).
• Mix shift (more patients evaluated with functional imaging vs alternative pathways).
• Geographic adoption where secretin-based protocols are standardized in radiology practices.

Projection framing Given s i n c a l i d e’s role as a diagnostic stimulation agent rather than a systemic therapeutic, the most defensible forward indicators are:

• Growth in nuclear medicine imaging volumes.
• Stability or increases in biliary dyskinesia evaluation using cholescintigraphy pathways.
• Stable reimbursement for functional imaging and preserved clinical protocol use.

Downside risks to include in projections

• Ongoing replacement of secretin-based workflows with alternative functional assessments.
• Manufacturing or supply interruptions that temporarily reduce procedures.
• Competitive substitution by alternative secretin products if price and access favor substitutes.

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Actionable business implications (R&D, partnerships, and investment)

Where do companies typically create value for s i n c a l i d e?

1. Supply and manufacturing reliability
   • Maintaining uninterrupted availability is a primary value lever in mature injectable diagnostic drugs.
2. Formulation and packaging improvements
   • Reduced preparation steps and improved stability can affect adoption and hospital procurement.
3. Coverage and protocol alignment
   • Evidence dossiers that map to payer criteria and radiology department protocols can sustain ordering.

What does “clinical trials update” mean for commercialization?

For s i n c a l i d e, “clinical update” translates into:

• Posting and disseminating protocol-aligned evidence for imaging accuracy and workflow safety.
• Supporting radiology guideline consistency so departments do not swap away during procurement cycles.

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Key Takeaways

• S i n c a l i d e is a mature secretin-based diagnostic stimulation agent with use centered on nuclear medicine functional imaging pathways.
• Clinical trial activity is not characterized by new late-stage registrational programs; recent work tends to refine imaging protocol use and interpretive practices.
• Market durability depends on imaging procedure volumes, protocol stickiness, payer coverage for functional imaging, and supply reliability.
• Market growth is most plausibly driven by steady increases in nuclear medicine utilization and protocol persistence, with downside from pathway substitution and any supply constraints.

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FAQs

1) Is s i n c a l i d e undergoing Phase 3 development today?

No public signal indicates an active, late-stage Phase 3 registrational program for s i n c a l i d e in major trial registries at this update.

2) What clinical endpoints matter for s i n c a l i d e in the literature?

Studies typically focus on diagnostic response reproducibility, imaging timing/kinetics, and interpretive outcomes tied to gallbladder function assessment and tolerability.

3) What are the main demand drivers in real-world use?

Hospital nuclear medicine imaging volumes and protocol-driven utilization in biliary and pancreatic functional diagnostic pathways.

4) What are the largest commercial risks?

Workflow substitution to alternative tests and operational supply risk for a specialty injectable.

5) How can a manufacturer expand share without new pivotal trials?

Through supply reliability, product handling improvements, and protocol/payer-aligned evidence that sustains ordering within existing imaging pathways.

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References

[1] APA, American Psychiatric Association. (n.d.). Diagnostic and Statistical Manual of Mental Disorders (DSM) (not applicable to s i n c a l i d e).
[2] ClinicalTrials.gov. (n.d.). Search results for s i n c a l i d e. https://clinicaltrials.gov/
[3] U.S. Food and Drug Administration. (n.d.). Drug approvals and labeling for secretin-based diagnostic products. https://www.accessdata.fda.gov/scripts/cder/daf/
[4] Society of Nuclear Medicine and Molecular Imaging (SNMMI). (n.d.). Guidance and practice considerations for functional imaging protocols. https://www.snmmi.org/