LY2608204 Clinical Trials

Size	Price	Qty
5mg	USD 270

Clinical Trials

The clinical development of LY2608204 comprises a clinical trial sponsored by Eli Lilly and Company for the treatment of type 2 diabetes mellitus. This Phase 2 study evaluated the compound as a monotherapy or in combination with metformin to assess its therapeutic utility and safety profile. However, the trial was prematurely closed, with its official recruitment status listed as withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01408095	Withdrawn	Diabetes Mellitus Type 2	Eli Lilly and Company	2011-09	Phase 2

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

Check the LY2608204 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY2608204 functions as a potent glucokinase activator with an EC50 of 42 nM, binding directly to the enzyme to enhance glucose phosphorylation and stimulate glucose-dependent insulin secretion from pancreatic beta cells. By accelerating hepatic glucose utilization and lowering circulating plasma glucose, this targeted activation counteracts hyperglycemia, demonstrating therapeutic relevance in the management of type 2 diabetes mellitus.

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>).