Uzansertib (INCB053914) Clinical Trials

Size	Price	Qty
1mg	USD 170
5mg	USD 490

Clinical Trials

Several clinical trials evaluate uzansertib (INCB053914) as both monotherapy and combination therapy for hematologic malignancies and advanced solid tumors, specifically relapsed or refractory diffuse large B-cell lymphoma and multiple myeloma. Sponsored by industry entities such as Incyte Corporation alongside academic institutions including the Medical College of Wisconsin, these Phase 1 and Phase 1/2 studies reflect portfolio recruitment statuses including completed, terminated, and withdrawn protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04355039	WITHDRAWN	Refractory Multiple Myeloma; Relapse Multiple Myeloma	Medical College of Wisconsin	2021-07-01	PHASE1
NCT03688152	COMPLETED	Relapsed Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma	Incyte Corporation	2018-12-03	PHASE1
NCT02587598	TERMINATED	Solid Tumors	Incyte Corporation	2015-12-29	PHASE1; PHASE2
NCT03688152	Completed	Relapsed Diffuse Large B-Cell Lymphoma\|Refractory Diffuse Large B-Cell Lymphoma	Incyte Corporation	2018-12-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2020-08-19)

Check the Uzansertib (INCB053914) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Uzansertib (INCB053914) functions as an ATP-competitive pan-inhibitor of PIM kinases (PIM1, PIM2, and PIM3), binding the active kinase domain to block downstream substrate phosphorylation crucial for cell survival and protein synthesis. By disrupting these oncogenic survival pathways, the compound induces apoptosis and suppresses cellular proliferation, providing potential therapeutic efficacy against PIM-driven tumor progression in diffuse large B-cell lymphoma, multiple myeloma, 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>).