Berberine chloride Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 247

Clinical Trials

Multiple early phase 1, phase 1, and non-phase specific clinical trials are evaluating the pharmacological profiles and therapeutic potential of berberine chloride for metabolic and inflammatory conditions—including polycystic ovary syndrome, diabetes mellitus, and ulcerative colitis—alongside pharmacokinetic assessments in healthy volunteers. Led by prominent institutions such as University Medicine Greifswald, Beijing Tongren Hospital, Ayub Teaching Hospital, and the National Cancer Institute, these completed, active, and upcoming studies aim to elucidate the compound's systemic kinetics, hormonal effects, and clinical efficacy across metabolic and gastrointestinal pathologies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06273241	Not yet recruiting	Pharmacokinetic Study in Healthy Volunteers	University Medicine Greifswald	2024-03-04	Not Applicable
NCT05845931	Recruiting	Pharmacokinetic Study in Healthy Volunteers	University Medicine Greifswald	2023-05-05	Not Applicable
NCT05947370	COMPLETED	Diabetes Mellitus	Beijing Tongren Hospital	2022-10-12	EARLY_PHASE1
NCT05480670	Completed	Polycystic Ovary Syndrome	Ayub Teaching Hospital	2022-11-01	Not Applicable
NCT05463003	Completed	Pharmacokinetic Study in Healthy Volunteers	University Medicine Greifswald	2022-07-19	Not Applicable
NCT03972215	COMPLETED	Diabetes Mellitus	Jin-Kui Yang	2019-10-01	EARLY_PHASE1
NCT02365480	COMPLETED	Ulcerative Colitis	National Cancer Institute (NCI)	2016-06-16	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Berberine chloride functions as a dual topoisomerase I and II inhibitor and autophagy modulator that suppresses c-IAP1, Bcl-2, and Bcl-XL expression while promoting cytochrome c release and PARP cleavage. This cascade triggers sustained JNK and p38 MAPK phosphorylation, reactive oxygen species generation, and caspase-3 and caspase-8 activation to induce apoptosis, underpinning its therapeutic potential in clinical trial conditions such as ulcerative colitis, diabetes mellitus, and polycystic ovary syndrome.

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>).