Simurosertib Clinical Trials

Size	Price	Qty
5mg	USD 290
100mg	USD 2,177

Clinical Trials

Several completed Phase 1 and Phase 2 clinical trials sponsored by Takeda and Millennium Pharmaceuticals Inc. have evaluated simurosertib (TAK-931) across various advanced malignancies, including solid neoplasms, nonhematologic cancers, and metastatic pancreatic, colorectal, esophageal, and non-small-cell lung carcinomas. Early-phase studies assessed safety, pharmacokinetics, bioavailability, and food effects, while Phase 2 research investigated single-agent therapeutic safety and antitumor activity.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03708211	Completed	Neoplasms Advanced Solid	Millennium Pharmaceuticals Inc.\|Takeda	2019-03-28	Phase 1
NCT03261947	Completed	Metastatic Pancreatic Cancer\|Colorectal Cancer\|Esophageal Neoplasms\|Carcinoma Non-small-cell Lung	Millennium Pharmaceuticals Inc.\|Takeda	2017-10-25	Phase 2
NCT02699749	Completed	Nonhematologic Neoplasms Advanced	Millennium Pharmaceuticals Inc.\|Takeda	2016-03-24	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Simurosertib functions as a potent, ATP-competitive, selective inhibitor of cell division cycle 7 (CDC7) kinase, which disrupts DNA replication activation to induce S-phase delay and replication stress. This molecular blockade leads to centrosome dysregulation, chromosome missegregation, and mitotic aberrations that drive irreversible antiproliferative effects, offering a targeted approach to inhibit tumor growth in advanced solid malignancies such as pancreatic, colorectal, esophageal, and non-small-cell lung 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>).