The Food and Drug Administration (FDA) has granted Fast Track designation to the investigational drug AZD3293 (Eli Lilly and AstraZeneca) for the treatment of Alzheimer’s disease.

AZD3293 is currently being investigated in an ongoing Phase 2/3 trial, the AMARANTH study. In addition, the companies also planned to initiate a second Phase 3 study, DAYBREAK-ALZ, to evaluate the efficacy and safety of AZD3293 in patients with mild Alzheimer’s dementia. Enrollment for this study began in the third quarter of 2016. 

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AZD3293 is an oral inhibitor of beta secretase cleaving enzyme (BACE), an enzyme associated with the development of amyloid beta. Accumulation of amyloid plaque in the brain contributes to the progression of Alzheimer’s disease. In clinical trials, AZD3293 was shown to reduce amyloid beta levels in the cerebro-spinal fluid.

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