LY3143921 hydrate Clinical Trials

Size	Price	Qty
5mg	USD 329
25mg	USD 987

Clinical Trials

Multiple Phase 1 clinical trials, sponsored by Cancer Research UK, evaluate orally administered LY3143921 hydrate in patients with advanced solid malignancies, including colorectal, high-grade serous ovarian, triple-negative breast, pancreatic, urothelial, and HPV-negative head and neck carcinomas. With recruitment statuses spanning active to completed, these early-phase evaluations focus on establishing safety, tolerability, and preliminary efficacy across diverse advanced tumor types.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03096054	COMPLETED	Colorectal Cancer; High Grade Serous Ovarian Cancer; Non Small-cell Lung Cancer (Squamous Cell Variant); Urothelial Cancer; Breast Cancer (Triple Negative Type); Pancreatic Cancer; Squamous Carcinoma of the Head and Neck (Human Papillomavirus (HPV) Negative)	Cancer Research UK	2017-06-21	PHASE1
NCT03096054	Active not recruiting	a. Colorectal Cancer\|b. High Grade Serous Ovarian Cancer\|c. Non Small-cell Lung Cancer (Squamous Cell Variant)\|d. Squamous Carcinoma of the Oesophagus\|e. Squamous Carcinoma of the Head and Neck (HPV Negative)\|f. Urothelial Cancer\|g. Breast Cancer (Triple Negative Type)\|h. Pancreatic Cancer	Cancer Research UK	2017-06-21	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-18)

Check the LY3143921 hydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY3143921 hydrate acts as an ATP-competitive inhibitor of cell division cycle 7 (CDC7) kinase, which prevents the phosphorylation of MCM2 at Ser53 and halts the initiation of DNA replication. By disrupting replication origin firing and triggering cell cycle arrest and apoptosis, this compound suppresses tumor growth across advanced solid malignancies, including colorectal, ovarian, and triple-negative breast 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>).