Ifebemtinib (IN10018, BI-853520) Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

Multiple clinical trials are currently evaluating the safety, tolerability, pharmacokinetics, and efficacy of the focal adhesion kinase inhibitor ifebemtinib (IN10018) in combination with CDK4/6 inhibitors and other novel oncology therapeutics. Sponsored by entities such as Capital Medical University and InxMed (Shanghai) Co., Ltd., these Phase 1 and Phase 1b/2 investigations focus on advanced solid tumors and meningioma. Current recruitment statuses for these evaluations include actively recruiting as well as active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07652762	RECRUITING	Meningioma; CDK4/6 Inhibitor	Capital Medical University	2026-08	PHASE1
NCT06166836	ACTIVE_NOT_RECRUITING	Solid Tumor	InxMed (Shanghai) Co., Ltd.	2022-10-12	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-07)

Check the Ifebemtinib (IN10018, BI-853520) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ifebemtinib selectively binds to and potently inhibits focal adhesion kinase (FAK), suppressing FAK autophosphorylation and disrupting downstream focal adhesion-mediated signaling cascades essential for cellular survival and migration. This targeted enzymatic inhibition impairs cellular spheroid formation and orthotopic tumor expansion, demonstrating clinical relevance for treating advanced solid tumors and meningioma.

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>).