Zunsemetinib Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials encompass Phase I and Phase II investigations evaluating zunsemetinib across oncology and inflammatory indications, supported by academic and industry sponsors. Studies assessing combination therapies in hormone receptor-positive, HER2-negative metastatic breast cancer and metastatic pancreatic ductal adenocarcinoma are currently recruiting patients. Additionally, a clinical trial investigating the efficacy and safety of the compound for psoriatic arthritis has been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06374459	RECRUITING	Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer	Washington University School of Medicine	2025-01-30	PHASE1; PHASE2
NCT06648434	RECRUITING	Metastatic Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Cancer of the Pancreas	Washington University School of Medicine	2025-06-13	PHASE1
NCT05511519	TERMINATED	Psoriatic Arthritis	Aclaris Therapeutics, Inc.	2022-07-12	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zunsemetinib selectively binds to and inhibits p38α mitogen-activated protein kinase-activated protein kinase 2 (MK2), thereby blocking downstream pro-inflammatory cytokine cascades and cellular stress signaling pathways. By suppressing MK2-mediated inflammatory and cell survival responses, this agent attenuates pathological tissue inflammation and disrupts tumor-supportive microenvironments, providing therapeutic potential in inflammatory conditions like psoriatic arthritis as well as advanced solid tumors including breast and pancreatic cancers.

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>).