BLU-945 Clinical Trials

Size	Price	Qty
5mg	USD 597
25mg	USD 1,790

Clinical Trials

Multiple clinical trials sponsored primarily by Blueprint Medicines Corporation evaluate BLU-945 in early-stage Phase 1 and Phase 1/2 studies for patients with EGFR-mutant non-small cell lung cancer, including lung adenocarcinoma, and thoracic neoplasms. The program specifically targets acquired tyrosine kinase inhibitor resistance driven by mutant EGFR forms, such as T790M, C797S, L858R, and exon 19 deletions. Current documentation indicates recruitment statuses across these studies range from active but no longer recruiting to terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04862780	TERMINATED	Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Disease; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; EGFR T790M; EGFR C797S; EGFR L858R; EGFR Gene Mutation; EGF-R Positive Non-Small Cell Lung Cancer; EGFR Exon 19 Deletion; EGFR Mutation Resulting in Tyrosine Kinase Inhibitor Resistance; EGFR Activating Mutation; Protein Kinase Inhibitors; Antineoplastic Agents; Thoracic Neoplasms	Blueprint Medicines Corporation	2021-06-29	PHASE1
NCT04862780	Active not recruiting	Lung Neoplasms\|Carcinoma Non-Small-Cell Lung\|Respiratory Tract Neoplasms\|Neoplasms\|Neoplasms by Site\|Lung Diseases\|Respiratory Tract Disease\|Carcinoma Bronchogenic\|Bronchial Neoplasms\|Adenocarcinoma\|Carcinoma\|Neoplasms by Histologic Type\|Neoplasms Nerve Tissue\|EGFR T790M\|EGFR C797S\|EGFR L858R\|EGFR Gene Mutation\|EGF-R Positive Non-Small Cell Lung Cancer\|EGFR Exon 19 Deletion\|EGFR Mutation Resulting in Tyrosine Kinase Inhibitor Resistance\|EGFR Activating Mutation\|Protein Kinase Inhibitors\|Antineoplastic Agents\|Thoracic Neoplasms	Blueprint Medicines Corporation	2021-06-29	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-02-10)

Check the BLU-945 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BLU-945 acts as a potent, reversible, and selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that binds the ATP-binding domain of mutant EGFR to block downstream oncogenic kinase signaling, thereby arresting cell cycle progression and triggering apoptosis in malignant cells. By specifically inhibiting triple-mutant and double-mutant EGFR variants carrying resistance alterations such as T790M and C797S, this agent suppresses tumor proliferation and restores therapeutic sensitivity in EGFR-mutant 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>).