Clinical Trials

A completed Phase 3 clinical trial, sponsored by the Children's Hospital Medical Center in Cincinnati, evaluated glycocholic acid and related conjugated bile acid therapies in pediatric and clinical cohorts. The study focused on metabolic conditions, including bile acid synthesis defects as well as inborn errors of bile acid metabolism and conjugation. Ultimately, this research underscores the therapeutic potential of bile acid supplementation in addressing metabolic dysfunction caused by congenital conjugation defects.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01589523 COMPLETED
Bile Acid Synthesis Defect; Inborn Error of Bile Acid Metabolism; Inborn Error of Bile Acid Conjugation
Children's Hospital Medical Center, Cincinnati
 2006-02 PHASE3

(data from https://clinicaltrials.gov, updated on 2022-06-08)

Check the Glycocholic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an endogenous conjugated bile acid, glycocholic acid integrates into mixed lipid micelles to facilitate the emulsification, solubilization, and intestinal absorption of dietary fats and hydrophobic nutrients. By driving micellar transport and modulating biliary lipid secretion, it maintains hepatic metabolic homeostasis, which is clinically relevant for addressing functional deficiencies associated with inborn errors of bile acid metabolism and synthesis defects.

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.