Norcantharidin Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

A Phase 1 clinical trial sponsored by the pharmaceutical company Beijing Nuokangda Pharmaceutical Technology Co., Ltd. is evaluating the safety, tolerability, and pharmacokinetic profile of an injectable norcantharidin lipid microsphere formulation in patients with solid tumors. Although the recruitment status for this investigation is currently reported as unknown, clinical research for norcantharidin remains situated in this early phase, focusing on establishing safety parameters in solid tumor therapy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04673396	UNKNOWN	Solid Tumor	Beijing Nuokangda Pharmaceutical Technology Co., Ltd.	2020-09-22	PHASE1

(data from https://clinicaltrials.gov, updated on 2020-12-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Norcantharidin functions as a synthetic dual inhibitor of c-Met and epidermal growth factor receptor (EGFR), suppressing receptor autophosphorylation and downstream oncogenic signaling pathways to induce apoptosis and inhibit cell proliferation. Concurrently blocking these receptor tyrosine kinase signaling cascades provides the mechanistic basis for its anti-tumor efficacy against solid tumors in clinical investigation.

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>).