Monzosertib Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

A clinical trial is currently evaluating the oral CDC7 inhibitor monzosertib (AS-0141) for the treatment of haematological malignancies. Sponsored by the M.D. Anderson Cancer Center, this Phase 1b study is listed as not yet recruiting participants with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndrome. The trial will focus on establishing the safety, tolerability, and preliminary efficacy of monzosertib in these aggressive myeloid neoplasms with high unmet medical need.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07780565	NOT_YET_RECRUITING	Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome	M.D. Anderson Cancer Center	2027-01-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Monzosertib selectively binds to and inhibits cell division cycle 7 (CDC7) kinase with nanomolar potency, preventing downstream phosphorylation of MCM proteins crucial for DNA replication initiation. This biochemical blockade disrupts origin firing and stalls S-phase progression, promoting apoptotic cell death in rapidly dividing cells and supporting its therapeutic rationale in acute myeloid leukemia and myelodysplastic syndrome.

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>).