Semagacestat (LY450139) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Multiple completed clinical trials sponsored by Eli Lilly and Company evaluated the therapeutic profile of semagacestat for Alzheimer's disease. Spanning Phase 1, Phase 2, and Phase 3 stages, these investigations evaluated treatment efficacy and disease progression. Key protocols included randomized, placebo-controlled studies, open-label extension protocols, and Phase 1 trials assessing semagacestat-mediated inhibition of amyloid-beta generation in human subjects.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00594568	COMPLETED	Alzheimer's Disease	Eli Lilly and Company	2008-03	PHASE3
NCT01035138	COMPLETED	Alzheimer's Disease	Eli Lilly and Company	2009-12	PHASE3
NCT00762411	COMPLETED	Alzheimer's Disease	Eli Lilly and Company	2008-09	PHASE3
NCT01035138	Completed	Alzheimer''s Disease	Eli Lilly and Company	2009-12	Phase 3
NCT00762411	Completed	Alzheimer''s Disease	Eli Lilly and Company	2008-09	Phase 3
NCT00594568	Completed	Alzheimer''s Disease	Eli Lilly and Company	2008-03	Phase 3
NCT00765115	COMPLETED	Alzheimer Disease	Eli Lilly and Company	2006-07	PHASE1
NCT00765115	Completed	Alzheimer Disease	Eli Lilly and Company	2006-07	Phase 1
NCT00244322	COMPLETED	Alzheimer's Disease	Eli Lilly and Company	2005-10	PHASE2

(data from https://clinicaltrials.gov, updated on 2015-03-17)

Check the Semagacestat (LY450139) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Semagacestat selectively binds to and inhibits gamma-secretase, thereby blocking the proteolytic cleavage of amyloid precursor protein into neurotoxic amyloid-beta peptides and downregulating Notch signaling. By suppressing the cellular generation and accumulation of soluble amyloid-beta species, this inhibition aims to prevent amyloid plaque deposition and slow cognitive decline 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>).