β-Elemene Clinical Trials

Size	Price	Qty
5mg	USD 119
25mg	USD 357

Clinical Trials

Multiple clinical trials conducted by academic sponsors in China evaluate β-elemene for advanced oncological conditions, though their recruitment status is officially recorded as unknown. A Phase 3 trial sponsored by Sun Yat-sen University assesses β-elemene as maintenance therapy following standard treatment for newly diagnosed malignant gliomas, including glioblastoma, anaplastic astrocytoma, and anaplastic oligoastrocytoma. Additionally, a Phase 2 trial sponsored by China Medical University investigates β-elemene combined with EGFR tyrosine kinase inhibitors for patients with advanced, EGFR-TKI-resistant non-small cell lung cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02629757	UNKNOWN	Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma; Glioblastoma	Sun Yat-sen University	2015-04	PHASE3
NCT03123484	UNKNOWN	Non Small Cell Lung Cancer	China Medical University, China	2017-04	PHASE2

(data from https://clinicaltrials.gov, updated on 2018-02-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

β-Elemene exerts its antineoplastic activity by disrupting cellular proliferation pathways, inducing cell cycle arrest, and triggering apoptosis and autophagy in malignant cells. This multi-targeted inhibition of cell survival signaling underpins its clinical investigation in suppressing tumor progression in glioblastoma and overcoming resistance in non-small cell lung 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>).