Lithocholic acid Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate lithocholic acid and related bile acid derivatives, investigating therapeutic and physiological impacts in primary biliary cirrhosis, obesity, and healthy volunteer cohorts. Encompassing Phase 2 as well as unassigned phase studies, these protocols are sponsored by academic institutions such as North Dakota State University and the University of Reading, alongside pharmaceutical entities like Intercept Pharmaceuticals. Completed protocols evaluated gut microbiota alterations following gastric bypass surgery and lipid metabolism in primary biliary cirrhosis, while active recruitment is underway for a clinical trial examining bile acid supplementation in healthy populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07499414	RECRUITING	Healthy	University of Reading	2026-04-06
NCT02654496	Completed	Obesity	North Dakota State University	2016-01	--
NCT01865812	Completed	Primary Biliary Cirrhosis	Intercept Pharmaceuticals	2013-12-03	Phase 2

(data from https://clinicaltrials.gov, updated on 2026-03-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lithocholic acid acts as a toxic secondary bile acid that binds to and activates nuclear receptors including the vitamin D receptor, pregnane X receptor, and farnesoid X receptor to regulate downstream gene transcription involved in lipid metabolism and bile acid clearance. Activation of these pathways counteracts bile acid toxicity and mitigates intrahepatic cholestasis, highlighting its pathophysiological and therapeutic relevance in conditions such as primary biliary cirrhosis and obesity.

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>).