Daphnetin Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Several clinical trials sponsored by academic medical institutions, including The First Hospital of Jilin University and the First People's Hospital of Shenyang, are evaluating daphnetin capsules across inflammatory, vascular, and oncological indications. These exploratory to late-phase studies—with recruitment statuses ranging from unknown to actively recruiting—investigate conditions such as gynecological surgery-related lower extremity lymphedema (including a Phase 4 trial), vascular cognitive impairment, and post-chemotherapy maintenance therapy for epithelial ovarian cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07495397	RECRUITING	Epithelial Ovarian Cancer	The First Hospital of Jilin University	2025-11-01
NCT06507488	RECRUITING	Cerebrovascular Disorders	First People's Hospital of Shenyang	2025-07-07
NCT06329167	UNKNOWN	Lower Extremity Lymphedema	The First Hospital of Jilin University	2024-03-25	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-03-27)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Daphnetin functions as a natural coumarin-derived protein kinase inhibitor that suppresses EGFR, PKA, and PKC enzymatic activities while exerting cellular antioxidant and chelating effects. By blocking these key signal transduction cascades and reducing oxidative stress, daphnetin inhibits pathological cell proliferation and tissue inflammation, providing a rational mechanistic basis for its investigation in lower extremity lymphedema, cerebrovascular disorders, and epithelial ovarian cancer.

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>).