Bleximenib oxalate Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 590

Clinical Trials

Multiple clinical trials evaluate bleximenib across Phase 1 through Phase 3 development for hematologic malignancies, specifically targeting acute myeloid leukemia, acute lymphoblastic leukemia, and relapsed or refractory acute leukemias. These investigations—sponsored by entities including Janssen Research & Development, LLC, Beat AML, LLC, and Stichting Hemato-Oncologie voor Volwassenen Nederland—encompass first-in-human evaluations, combination regimens, and randomized protocols. Participant recruitment across this research portfolio ranges from active, not recruiting to actively recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03013998	RECRUITING	Previously Untreated Relapsed Refractory Acute Myeloid Leukemia	Beat AML, LLC	2016-11	PHASE2; PHASE3
NCT07223814	RECRUITING	Acute Myeloid Leukemia	Stichting Hemato-Oncologie voor Volwassenen Nederland	2026-03-01	PHASE3
NCT06852222	RECRUITING	Leukemia, Myeloid, Acute	Janssen Research & Development, LLC	2025-06-04	PHASE3
NCT04811560	RECRUITING	Acute Leukemia	Janssen Research & Development, LLC	2021-05-19	PHASE1; PHASE2
NCT05453903	ACTIVE_NOT_RECRUITING	Leukemia, Myeloid, Acute	Janssen Research & Development, LLC	2022-10-04	PHASE1
NCT07295951	RECRUITING	Acute Lymphoblastic Leukemia; Acute Leukemias; Acute Myeloid Leukemia	Janssen Research & Development, LLC	2025-11-18	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bleximenib oxalate directly binds to menin, effectively disrupting its interaction with mixed-lineage leukemia 1 (MLL1/KMT2A) and suppressing downstream oncogenic gene expression to induce cell differentiation and apoptosis. By inhibiting menin-MLL-mediated transcriptional activation, this targeted disruption halts leukemic cell proliferation, providing a mechanistically grounded therapeutic strategy directly relevant to clinical trial investigations in acute myeloid leukemia and acute lymphoblastic leukemia.

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>).