LY2090314 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 477

Clinical Trials

Sponsored by Eli Lilly and Company, several clinical trials have evaluated LY2090314 alone or alongside platinum-based chemotherapy across Phase 1, Phase 2, and Phase 1/2 designs in acute leukemia, advanced or metastatic cancer, and pancreatic cancer. Recruitment was completed for the Phase 1 study in advanced cancer and the Phase 2 trial in acute leukemia, whereas the Phase 1/2 study in pancreatic cancer was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01632306	TERMINATED	Pancreatic Cancer	Eli Lilly and Company	2013-03	PHASE1; PHASE2
NCT01214603	COMPLETED	Leukemia	Eli Lilly and Company	2010-11	PHASE2
NCT01287520	COMPLETED	Advanced Cancer	Eli Lilly and Company	2007-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2019-01-15)

Check the LY2090314 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY2090314 functions as a potent and selective inhibitor of glycogen synthase kinase-3 alpha and beta (GSK-3α/β), blocking GSK-3-mediated phosphorylation of downstream signaling substrates and disrupting key cellular survival pathways. By sensitizing malignant cells to apoptosis and chemotherapeutic agents, LY2090314 offers therapeutic potential in oncology, supporting its clinical investigation for indications such as leukemia, advanced solid tumors, and pancreatic cancer.

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>).