Verubecestat (MK-8931) Trifluoroacetate Clinical Trials

Size	Price	Qty
5mg	USD 147
100mg	USD 977

Clinical Trials

Multiple clinical trials sponsored by Merck Sharp & Dohme LLC have investigated verubecestat (MK-8931) across Phase 1, Phase 2, and Phase 3 studies for neurodegenerative conditions, including Alzheimer's disease, amnestic mild cognitive impairment, and prodromal Alzheimer's disease. While several clinical trials evaluating Phase 1 safety, tolerability, pharmacodynamics, and pharmacokinetic profiles in renal and hepatic impairment were successfully completed, major late-stage Phase 2/3 and Phase 3 trials were terminated prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01953601	TERMINATED	Amnestic Mild Cognitive Impairment; Alzheimer's Disease; Prodromal Alzheimer's Disease	Merck Sharp & Dohme LLC	2013-11-05	PHASE3
NCT01739348	TERMINATED	Alzheimer's Disease	Merck Sharp & Dohme LLC	2012-11-30	PHASE2; PHASE3
NCT02910739	COMPLETED	Amnestic Mild Cognitive Impairment; Alzheimer's Disease; Prodromal Alzheimer's Disease	Merck Sharp & Dohme LLC	2016-10-11	PHASE1
NCT02910739	Completed	Amnestic Mild Cognitive Impairment\|Alzheimer''s Disease\|Prodromal Alzheimer''s Disease	Merck Sharp & Dohme LLC	2016-10-11	Phase 1
NCT01496170	COMPLETED	Alzheimer's Disease	Merck Sharp & Dohme LLC	2011-12	PHASE1
NCT01537757	COMPLETED	Alzheimer's Disease	Merck Sharp & Dohme LLC	2012-03	PHASE1
NCT01537757	Completed	Alzheimer''s Disease	Merck Sharp & Dohme LLC	2012-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2019-05-17)

Check the Verubecestat (MK-8931) Trifluoroacetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Verubecestat (MK-8931) selectively binds to and inhibits beta-site APP-cleaving enzyme 1 (BACE1), thereby blocking the rate-limiting endoproteolytic cleavage of amyloid precursor protein. This inhibition suppresses the cellular generation and accumulation of toxic amyloid-beta peptides, providing the mechanistic basis for targeting neurodegenerative pathology in clinical trials for Alzheimer's disease and prodromal cognitive impairment.

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>).