Olmutinib (BI 1482694) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials sponsored by Boehringer Ingelheim and Hanmi Pharmaceutical Company Limited have evaluated Olmutinib (BI 1482694) in Phase 1 and Phase 2. Several clinical trials successfully completed Phase 1 evaluations of the drug's safety, pharmacokinetics, and metabolic profiles in healthy volunteers. Meanwhile, a clinical trial investigated its therapeutic efficacy in Phase 2 for patients with T790M-mutant non-small cell lung cancer prior to termination.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02722161	Completed	Healthy	Boehringer Ingelheim	2016-04	Phase 1
NCT02485652	Terminated	Non Small Cell Lung Cancer	Hanmi Pharmaceutical Company Limited	2015-08-31	Phase 2
NCT01894399	Completed	Healthy Volunteers	Hanmi Pharmaceutical Company Limited	2013-09	Phase 1

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

Check the Olmutinib (BI 1482694) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olmutinib selectively binds to mutant epidermal growth factor receptor (EGFR) tyrosine kinases, including the T790M mutation, which blocks downstream oncogenic signaling cascades and suppresses tumor cell proliferation. This target-specific inhibition of EGFR pathway activation ultimately impairs tumor progression, providing a clear biological rationale for its clinical evaluation in patients with 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>).