Avagacestat (BMS-708163) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Multiple clinical trials sponsored by pharmaceutical entities, including Bristol-Myers Squibb and PRA Health Sciences, have evaluated avagacestat across Phase 1 and Phase 2 development. Phase 1 trials in healthy volunteers completed recruitment to evaluate the compound's safety, pharmacokinetics, pharmacodynamics, and drug interactions. Conversely, Phase 2 trials assessing safety and therapeutic efficacy in patients with Alzheimer's disease were terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00890890	TERMINATED	Alzheimer's Disease	Bristol-Myers Squibb	2009-05	PHASE2
NCT01079819	COMPLETED	Alzheimer's Disease	Bristol-Myers Squibb	2010-04	PHASE1
NCT01002079	COMPLETED	Alzheimer Disease	Bristol-Myers Squibb	2010-08	PHASE1
NCT01002079	Completed	Alzheimer Disease	Bristol-Myers Squibb\|PRA Health Sciences	2010-08	Phase 1
NCT01057030	COMPLETED	Alzheimer Disease	Bristol-Myers Squibb	2010-03	PHASE1
NCT00810147	COMPLETED	Alzheimer's Disease	Bristol-Myers Squibb	2009-02	PHASE2
NCT01042314	COMPLETED	Alzheimer Disease	Bristol-Myers Squibb	2010-01	PHASE1
NCT01039194	COMPLETED	Alzheimer Disease	Bristol-Myers Squibb	2010-01	PHASE1
NCT01057030	Completed	Alzheimer Disease	Bristol-Myers Squibb	2010-03	Phase 1
NCT00979316	COMPLETED	Alzheimer Disease	Bristol-Myers Squibb	2009-09	PHASE1
NCT01042314	Completed	Alzheimer Disease	Bristol-Myers Squibb	2010-01	Phase 1
NCT01039194	Completed	Alzheimer Disease	Bristol-Myers Squibb	2010-01	Phase 1
NCT00979316	Completed	Alzheimer Disease	Bristol-Myers Squibb	2009-09	Phase 1
NCT00901498	COMPLETED	Alzheimer's Disease; Healthy	Bristol-Myers Squibb	2009-05	PHASE1
NCT00828646	COMPLETED	Healthy	Bristol-Myers Squibb	2008-10	PHASE1
NCT00860275	COMPLETED	Alzheimer Disease	Bristol-Myers Squibb	2009-04	PHASE1
NCT00890890	Terminated	Alzheimer''s Disease	Bristol-Myers Squibb	2009-05	Phase 2
NCT01454115	COMPLETED	Alzheimer's Disease	Bristol-Myers Squibb	2007-06	PHASE1
NCT00726726	COMPLETED	Alzheimer Disease	Bristol-Myers Squibb	2008-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2015-10-12)

Check the Avagacestat (BMS-708163) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Avagacestat (BMS-708163) selectively binds to and inhibits γ-secretase, thereby blocking the endoproteolytic cleavage of amyloid precursor protein and suppressing cellular production of neurotoxic amyloid-beta peptides Aβ40 and Aβ42. This decrease in amyloid-beta generation attenuates extracellular plaque deposition and neurotoxicity, providing the mechanistic rationale for targeting pathology in clinical trial populations with 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>).