Icariin Clinical Trials

Size	Price	Qty
100mg	USD 197

Clinical Trials

Multiple clinical trials, with statuses ranging from completed to not yet recruiting, evaluate the pharmacokinetic profile and therapeutic efficacy of icariin across diverse indications. Early-stage research by the University of Texas Southwestern Medical Center in collaboration with NCCIH established its human pharmacokinetics, while advanced clinical trials addressed bipolar disorder and substance use disorder. Additionally, research sponsored by Seoul National University Hospital focuses on dermatological outcomes in acne and acne scars, alongside a planned trial evaluating icariin soft capsules as adjuvant therapy for hepatocarcinoma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06900478	NOT_YET_RECRUITING	Hepatocarcinoma	Hua Li	2025-03-30	PHASE2
NCT07076784	COMPLETED	Acne; Acne Scars	Seoul National University Hospital	2023-03-21
NCT02112123	COMPLETED	the Pharmacokinetic Profile of Icariin in Humans	University of Texas Southwestern Medical Center	2014-04	PHASE1
NCT01979133	COMPLETED	Bipolar Disorder; Substance Use Disorder	University of Texas Southwestern Medical Center	2013-10	PHASE3
NCT02112123	Completed	the Pharmacokinetic Profile of Icariin in Humans	University of Texas Southwestern Medical Center\|National Center for Complementary and Integrative Health (NCCIH)	2014-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-03-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Icariin selectively binds to and inhibits cGMP-specific phosphodiesterase-5 (PDE5), thereby blocking the catalytic hydrolysis of cGMP and promoting intracellular cyclic GMP accumulation. This enhancement of cGMP downstream signaling regulates vascular tone, cellular proliferation, and neuroprotective mechanisms, establishing a therapeutic basis for its clinical exploration in hepatocarcinoma, acne, and neuropsychiatric disorders.

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>).