Emodin Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate interventions associated with this compound or related natural formulations across distinct health conditions, including autosomal dominant polycystic kidney disease as well as sleep disturbance and quality of life in postmenopausal women. Sponsored by academic and medical entities such as KTO Karatay University and clinical investigator Dr. Zhi-Hong Liu, these trials do not specify standard phase designations. Regarding recruitment status, the polycystic kidney disease study was terminated, whereas the investigation examining postmenopausal sleep and quality of life has been completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07065526	COMPLETED	Postmenopausal; Sleep; Quality of Life	KTO Karatay University	2023-09-15
NCT00801268	TERMINATED	Polycystic Kidney	Zhi-Hong Liu, M.D.	2008-11

(data from https://clinicaltrials.gov, updated on 2025-07-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Emodin modulates key cellular signaling networks such as the nuclear factor-κB and casein kinase II pathways, blocking downstream proinflammatory cytokine expression and downregulating anti-apoptotic signaling. This biochemical inhibition suppresses abnormal cell proliferation and promotes programmed cell death, offering a mechanistic rationale for its study in proliferative and inflammatory conditions like polycystic kidney disease.

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>).