Clinical Trials

Multiple clinical trials currently evaluate puerarin, focusing primarily on Phase II studies across conditions such as obesity, alcohol use disorder, rheumatoid arthritis, alveolar cleft grafting, and cardiovascular disease risk factors. Supported by academic and medical institutions—including Ruijin Hospital, McLean Hospital, Cairo University, Chengdu PLA General Hospital, and The University of Hong Kong—these studies maintain varying recruitment statuses ranging from completed to unknown and not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06968208 NOT_YET_RECRUITING
Metabolic Diseases; Obesity/Therapy
Ruijin Hospital
 2025-08-01 PHASE2
NCT03676296 COMPLETED
Cardiovascular Disease Risk Factors
The University of Hong Kong
 2018-09-05 PHASE2
NCT03099590 COMPLETED
Alcohol Drinking; Alcohol Use Disorder; Alcohol Abstinence
Mclean Hospital
 2018-01-01 PHASE2
NCT02219191 UNKNOWN
Rheumatoid Arthritis
Chengdu PLA General Hospital
 2014-08
NCT02264301 UNKNOWN
Rheumatoid Arthritis
Chengdu PLA General Hospital
 2014-08
NCT02254655 COMPLETED
Rheumatoid Arthritis
Chengdu PLA General Hospital
 2013-11 PHASE2
NCT03016793 UNKNOWN
Alveolar Cleft Grafting
Cairo University
 2017-01 PHASE2
NCT00854724 COMPLETED
Alcohol Abuse
Mclean Hospital
 2009-02 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-05-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Puerarin acts as an antagonist at 5-HT2C receptors and benzodiazepine binding sites, effectively blocking downstream receptor-mediated second messenger signaling cascades and altering cellular neurotransmitter responses. This targeted signal inhibition modulates central neural circuitry and systemic inflammatory pathways, providing the biological basis for its investigation in clinical trials for alcohol use disorder, metabolic syndrome, cardiovascular disease risk, and rheumatoid arthritis.

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.