Sotuletinib (BLZ945) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 597

Clinical Trials

Sotuletinib (BLZ945) has been evaluated in several Phase 1, Phase 1/2, and Phase 2 clinical trials, sponsored primarily by Novartis Pharmaceuticals. These studies assess the safety, tolerability, and therapeutic efficacy of the compound—administered alone or in combination—for advanced solid tumors and neurodegenerative conditions such as Amyotrophic Lateral Sclerosis (ALS). Across these oncology and neuroinflammatory trials, recruitment statuses are reported as active, not recruiting, or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04066244	TERMINATED	Amyotrophic Lateral Sclerosis	Novartis Pharmaceuticals	2019-12-30	PHASE2
NCT02829723	TERMINATED	Advanced Solid Tumors	Novartis Pharmaceuticals	2016-10-21	PHASE1; PHASE2
NCT04066244	Active not recruiting	Amyotrophic Lateral Sclerosis	Novartis Pharmaceuticals\|Novartis	2019-12-30	Phase 2
NCT02829723	Terminated	Advanced Solid Tumors	Novartis Pharmaceuticals\|Novartis	2016-10-21	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-10-16)

Check the Sotuletinib (BLZ945) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sotuletinib (BLZ945) functions as a potent, selective colony-stimulating factor 1 receptor (CSF-1R) inhibitor that binds the receptor to block auto-phosphorylation and downstream survival signaling in myeloid cells. By depleting tumor-associated macrophages and modulating hyperactive microglial responses, this mechanistic blockade reduces neuroinflammation and alters the immunosuppressive tumor microenvironment in clinical contexts such as Amyotrophic Lateral Sclerosis and advanced solid tumors.

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>).