Bozitinib Clinical Trials

Size	Price	Qty
2mg	USD 179
5mg	USD 357

Clinical Trials

Several clinical trials, spanning Phase I to Phase II, are evaluating bozitinib in patients with glioma and non-small cell lung cancer harboring MET exon 14 or activating mutations. Sponsored by academic institutions and biotechnology companies, these studies range from completed safety and pharmacokinetic evaluations to actively recruiting combination trials. Overall, these programs aim to establish the safety, efficacy, and optimal dosing of bozitinib for MET-driven malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07153770	NOT_YET_RECRUITING	NSCLC; MET Exon 14 Mutation; MET Activating Mutation	Shanghai Pulmonary Hospital, Shanghai, China	2025-09-20	PHASE2
NCT04743505	Recruiting	Metastatic Non Small Cell Lung Cancer	Washington University School of Medicine\|Apollomics Inc.	2022-01-18	Phase 1\|Phase 2
NCT02978261	Completed	Glioma	Beijing Pearl Biotechnology Limited Liability Company	2016-09	Phase 1
NCT02896231	Completed	Non-Small Cell Lung Cancer	Beijing Pearl Biotechnology Limited Liability Company	2016-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-09-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bozitinib functions as a highly selective, ATP-competitive c-Met inhibitor that binds the kinase domain to prevent receptor autophosphorylation and block downstream oncogenic signaling cascades. By suppressing these survival pathways to inhibit cellular proliferation and trigger apoptosis in MET-altered tumor cells, bozitinib provides therapeutic efficacy against c-Met-driven malignancies such as non-small cell lung cancer and blood-brain barrier-permeable glioma.

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>).