LY2811376 Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Multiple clinical trials sponsored by Eli Lilly and Company have evaluated LY2811376 for the potential treatment of Alzheimer's disease. These Phase 1 studies assessed preliminary safety, tolerability, and pharmacokinetic-pharmacodynamic profiles following single ascending doses in healthy volunteers to characterize initial biomarker responses. The trials have achieved completed recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00838084	COMPLETED	Alzheimer's Disease	Eli Lilly and Company	2008-12	PHASE1
NCT00838084	Completed	Alzheimer''s Disease	Eli Lilly and Company	2008-12	Phase 1

(data from https://clinicaltrials.gov, updated on 2009-07-15)

Check the LY2811376 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY2811376 selectively binds to and inhibits β-secretase 1 (BACE1), thereby blocking the initial rate-limiting cleavage of amyloid precursor protein and decreasing cellular secretion of beta-amyloid peptides. This reduction in beta-amyloid production prevents downstream neurotoxic plaque accumulation, providing direct therapeutic relevance to clinical evaluations in Alzheimer's disease.

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>).