SY-5609 Clinical Trials

Size	Price	Qty
1mg	USD 290
5mg	USD 870

Clinical Trials

Multiple early-phase clinical trials sponsored by commercial entities are establishing the safety profile and therapeutic utility of SY-5609 across refractory solid malignancies. A completed Phase 1 study sponsored by Syros Pharmaceuticals evaluated oral SY-5609 in adult patients with advanced solid tumors, including breast, small-cell lung, and pancreatic cancers. Additionally, Hoffmann-La Roche is currently sponsoring an ongoing, recruiting Phase 1/1b global trial evaluating targeted therapeutic strategies in patient subpopulations with metastatic colorectal cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04929223	RECRUITING	Metastatic Colorectal Cancer	Hoffmann-La Roche	2021-10-22	PHASE1
NCT04247126	COMPLETED	Advanced Solid Tumor; Breast Cancer; Small-cell Lung Cancer; Pancreatic Cancer	Syros Pharmaceuticals	2020-01-23	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-17)

Check the SY-5609 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SY-5609 is a potent and highly selective inhibitor of cyclin-dependent kinase 7 (CDK7) that selectively binds the target kinase, thereby disrupting CDK7-mediated transcriptional regulation and cell cycle progression to induce apoptotic cell death in neoplastic cells. By halting tumor cell proliferation and promoting apoptosis through targeted CDK7 inhibition, SY-5609 provides a rational therapeutic strategy for suppressing tumor progression in advanced solid malignancies, including metastatic colorectal, pancreatic, breast, and 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>).