Elenbecestat Clinical Trials

Size	Price	Qty
2mg	USD 147
25mg	USD 970

Clinical Trials

Multiple clinical trials across early to late phases evaluated the small-molecule agent elenbecestat in healthy participants and patients with early Alzheimer's disease or Alzheimer's dementia. Sponsored primarily by Eisai and Biogen, several clinical trials successfully completed safety, tolerability, and pharmacokinetic evaluations in healthy subjects. Conversely, multiple clinical trials investigating disease progression in Alzheimer's patient cohorts were ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02956486	TERMINATED	Alzheimer's Disease	Eisai Co., Ltd.	2016-10-20	PHASE3
NCT03055962	Completed	Healthy Participants	Eisai Co. Ltd.\|Eisai Inc.	2017-02-14	Phase 1
NCT02859207	Completed	Early Alzheimer''s Disease	Eisai Inc.	2016-08	Phase 1
NCT02322021	Terminated	Alzheimer Disease\|Dementia Alzheimer Type	Eisai Inc.\|Biogen	2014-11-26	Phase 2
NCT02222324	Completed	Healthy Subjects	Eisai Inc.	2014-08	Phase 1
NCT02207790	Completed	Healthy Subjects	Eisai Inc.	2014-07	Phase 1

(data from https://clinicaltrials.gov, updated on 2021-02-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Elenbecestat is an oral small-molecule inhibitor that selectively binds to and inhibits beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), thereby blocking the rate-limiting cleavage of amyloid precursor protein and preventing the downstream generation of neurotoxic beta-amyloid peptides. By reducing neurotoxic peptide accumulation and circulating beta-amyloid levels, this targeted enzymatic inhibition aims to mitigate progressive neurodegeneration in clinical trial populations evaluated for early Alzheimer's disease and dementia.

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>).