Mubritinib (TAK 165) Clinical Trials

Size	Price	Qty
10mg	USD 147
200mg	USD 870

Clinical Trials

A completed Phase 1 clinical trial sponsored by Takeda evaluated the therapeutic application of orally administered Mubritinib (TAK 165) in patients with advanced solid tumors, specifically breast, pancreatic, lung, ovarian, and renal neoplasms. This early-phase study investigated the drug's safety, tolerability, maximum tolerated dose, and pharmacokinetic properties. Overall, the investigation established the agent's initial safety profile and preliminary therapeutic potential across these diverse oncologic indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00034281	Completed	Breast Neoplasm\|Pancreatic Neoplasm\|Lung Neoplasm\|Ovarian Neoplasm\|Renal Neoplasm	Takeda	2002-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Mubritinib (TAK 165) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mubritinib (TAK-165) selectively binds to and inhibits HER2/ErbB2 receptor tyrosine kinase activity, blocking downstream oncogenic signal transduction cascades and effectively suppressing cancer cell proliferation. This targeted inhibition leads to reduced tumor cell growth and survival, providing a strong biological rationale for its clinical investigation in solid tumor malignancies such as breast, lung, and renal neoplasms.

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>).