Vimseltinib Clinical Trials

Size	Price	Qty
5mg	USD 390

Clinical Trials

Multiple Phase 1, 2, and 3 clinical trials sponsored by Deciphera Pharmaceuticals evaluate the therapeutic potential and clinical pharmacology of vimseltinib in CSF-1-driven conditions, primarily tenosynovial giant cell tumor (including pigmented villonodular synovitis and giant cell tumor of tendon sheath), chronic graft-versus-host disease, and advanced malignant neoplasms. Additional Phase 1 studies in healthy participants evaluate drug-drug interactions and transporter dynamics. Recruitment statuses across these trials range from not yet recruiting and recruiting to active, not recruiting, and completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06619561	RECRUITING	Chronic Graft-Versus-Host Disease (cGVHD)	Deciphera Pharmaceuticals, LLC	2024-11-21	PHASE2
NCT03069469	ACTIVE_NOT_RECRUITING	Advanced Malignant Neoplasm; Pigmented Villonodular Synovitis; Giant Cell Tumor of Tendon Sheath; Tenosynovial Giant Cell Tumor; Tenosynovial Giant Cell Tumor, Diffuse	Deciphera Pharmaceuticals, LLC	2017-02-16	PHASE1; PHASE2
NCT07744802	NOT_YET_RECRUITING	Healthy Male Participants	Deciphera Pharmaceuticals, LLC	2026-09	PHASE1
NCT07539090	RECRUITING	Healthy Participants	Deciphera Pharmaceuticals, LLC	2026-06-05	PHASE1
NCT07158411	COMPLETED	Healthy Participants	Deciphera Pharmaceuticals, LLC	2025-11-20	PHASE1
NCT07158398	COMPLETED	Healthy Participants	Deciphera Pharmaceuticals, LLC	2025-10-31	PHASE1
NCT05059262	ACTIVE_NOT_RECRUITING	Tenosynovial Giant Cell Tumor; Pigmented Villonodular Synovitis; Giant Cell Tumor of Tendon Sheath; Tenosynovial Giant Cell Tumor, Diffuse; Tenosynovial Giant Cell Tumor, Localized	Deciphera Pharmaceuticals, LLC	2021-10-14	PHASE3
NCT03069469	Active not recruiting	Advanced Malignant Neoplasm\|Pigmented Villonodular Synovitis\|Giant Cell Tumor of Tendon Sheath\|Tenosynovial Giant Cell Tumor\|Tenosynovial Giant Cell Tumor Diffuse	Deciphera Pharmaceuticals LLC	2017-02-16	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-12-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vimseltinib is a potent dual inhibitor of c-FMS (CSF-1R) and c-Kit receptor tyrosine kinases that blocks receptor auto-phosphorylation and downstream intracellular signaling cascades required for macrophage proliferation, differentiation, and survival. By suppressing CSF-1R-mediated kinase activity and macrophage lineage activation, vimseltinib reduces pathogenic macrophage infiltration, providing a target-directed therapeutic mechanism in clinical conditions such as tenosynovial giant cell tumor and chronic graft-versus-host disease.

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>).