Lanabecestat (AZD3293) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 270

Clinical Trials

Multiple clinical trials sponsored primarily by AstraZeneca and Eli Lilly and Company have evaluated lanabecestat across Phase 1, Phase 2, and Phase 3. Early Phase 1 trials successfully assessed the drug's safety, mass balance, bioavailability, and pharmacokinetics in healthy volunteers as well as cohorts with renal insufficiency or hepatic impairment. However, late-phase clinical trials targeting mild-to-moderate Alzheimer's disease dementia, including pivotal Phase 3 studies investigating disease-modifying effects, were ultimately terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03545087	WITHDRAWN	Renal Insufficiency	Eli Lilly and Company	2018-06	PHASE1
NCT02245737	TERMINATED	Alzheimer´s Disease	AstraZeneca	2014-09-30	PHASE2; PHASE3
NCT02972658	TERMINATED	Alzheimer's Disease	AstraZeneca	2017-03-15	PHASE3
NCT03506399	WITHDRAWN	Healthy	Eli Lilly and Company	2018-06	PHASE1
NCT02783573	TERMINATED	Alzheimer's Disease	AstraZeneca	2016-07-01	PHASE3
NCT03499041	Withdrawn	Hepatic Impairment	Eli Lilly and Company\|AstraZeneca	2018-06	Phase 1
NCT03222427	Completed	Healthy	AstraZeneca\|Eli Lilly and Company	2018-01-15	Phase 1
NCT03019549	COMPLETED	Healthy	AstraZeneca	2017-01-12	PHASE1
NCT03019549	Completed	Healthy	AstraZeneca\|Eli Lilly and Company	2017-01-12	Phase 1
NCT02663128	COMPLETED	Healthy	AstraZeneca	2016-01-31	PHASE1
NCT02568397	COMPLETED	Healthy	AstraZeneca	2015-10-31	PHASE1
NCT02540668	COMPLETED	Healthy	AstraZeneca	2015-09-30	PHASE1
NCT02663128	Completed	Healthy	AstraZeneca\|Eli Lilly and Company	2016-01-31	Phase 1
NCT02406261	COMPLETED	Healthy	AstraZeneca	2015-04-30	PHASE1
NCT02005211	COMPLETED	Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers	AstraZeneca	2013-12	PHASE1
NCT02126514	COMPLETED	Healthy Volunteers; Mass Balance Study	AstraZeneca	2014-05	PHASE1
NCT02040987	COMPLETED	Alzheimer's Disease	AstraZeneca	2014-01	PHASE1
NCT01795339	COMPLETED	Healthy Elderly Volunteers; Mild-to-moderate Alzheimer's Disease Patients	AstraZeneca	2013-03	PHASE1
NCT02039180	COMPLETED	Healthy Volunteers; Pharmacologic Action	AstraZeneca	2014-02	PHASE1
NCT02010970	COMPLETED	Healthy Volunteers; Pharmacologic Action	AstraZeneca	2013-12	PHASE1
NCT01739647	COMPLETED	Healthy Young Volunteers; Healthy Elderly Volunteers	AstraZeneca	2012-12	PHASE1

(data from https://clinicaltrials.gov, updated on 2018-06-28)

Check the Lanabecestat (AZD3293) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lanabecestat is a potent, oral beta-secretase 1 inhibitor with a Ki of 0.4 nM that selectively binds the BACE1 enzyme to block the proteolytic cleavage of amyloid precursor protein, preventing the formation of amyloid-beta peptides. By reducing toxic amyloid-beta accumulation in brain tissue, this compound was clinically investigated to suppress neurodegenerative pathology and slow disease progression in patients 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>).