Clinical Trials

Multiple clinical trials sponsored by Eli Lilly and Company have evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics, and metabolic disposition of LY2886721 using single- and multiple-ascending dose designs. This Phase 1 and Phase 2 development program enrolled both healthy volunteers and patients with Alzheimer's disease. While the majority of these studies are completed, recruitment for select trials was terminated during evaluation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01561430 TERMINATED
Alzheimer's Disease
Eli Lilly and Company
2012-03 PHASE1; PHASE2
NCT01775904 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2013-02 PHASE1
NCT01807026 COMPLETED
Alzheimer Disease; Healthy Volunteers
Eli Lilly and Company
2013-03 PHASE1
NCT01807026 Completed
Alzheimer Disease|Healthy Volunteers
Eli Lilly and Company
2013-03 Phase 1
NCT01534273 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2012-02 PHASE1
NCT01534273 Completed
Healthy Volunteers
Eli Lilly and Company
2012-02 Phase 1
NCT01367262 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2011-06 PHASE1
NCT01367262 Completed
Healthy Volunteers
Eli Lilly and Company
2011-06 Phase 1
NCT01227252 COMPLETED
Alzheimer's Disease
Eli Lilly and Company
2010-12 PHASE1
NCT01227252 Completed
Alzheimer''s Disease
Eli Lilly and Company
2010-12 Phase 1
NCT01133405 COMPLETED
Alzheimer's Disease
Eli Lilly and Company
2010-06 PHASE1
NCT01133405 Completed
Alzheimer''s Disease
Eli Lilly and Company
2010-06 Phase 1

(data from https://clinicaltrials.gov, updated on 2018-05-18)

Check the LY2886721 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY2886721 functions as a selective inhibitor of beta-site amyloid precursor protein cleaving enzyme (BACE), thereby blocking the initial rate-limiting proteolytic cleavage of amyloid precursor protein. By preventing downstream amyloid-beta peptide generation and toxic plaque accumulation, this inhibition targets the underlying neurodegenerative pathway to potentially arrest disease progression 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>).

Note: Technical data last updated: Sep 1, 2026.