Clinical Trials

Several clinical trials have evaluated CCK Octapeptide (Sincalide) across various clinical indications and research settings. Primary investigations have focused on conditions such as parenteral nutrition-associated cholestasis in neonates as well as physiological response studies in healthy volunteers. These evaluations include Phase 3 trials and dose-response investigations sponsored by academic and government entities, including the University of Michigan, Temple University, and the National Institute of Diabetes and Digestive and Kidney Diseases. Key completed trials, including NCT00004414, NCT00706381, and NCT00685477, have examined pediatric cholestasis outcomes, thyroid hormone homeostasis during bile acid stimulation, and gallbladder contraction dynamics.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00706381 COMPLETED
Healthy Volunteers
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2008-06-23 PHASE3
NCT00685477 COMPLETED
Healthy
Temple University
 2008-05
NCT00004414 COMPLETED
Cholestasis
University of Michigan
 1997-09

(data from https://clinicaltrials.gov, updated on 2020-07-22)

Check the CCK Octapeptide (Sincalide) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CCK Octapeptide acts as a cholecystokinin receptor agonist that binds to specific G-protein-coupled receptors in the gastrointestinal tract, initiating intracellular calcium mobilization and downstream signaling pathways. This biochemical activation induces smooth muscle contraction in the gallbladder and secretion of digestive enzymes, which enhances bile flow and provides the mechanistic basis for assessing gallbladder function and managing cholestasis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.