Lecanemab (Leqembi) timeline
Current statusU.S.-approved for treatment begun at the mild cognitive impairment or mild dementia stage with confirmed amyloid pathology. FDA approved subcutaneous initiation on July 13, 2026. AHEAD 3-45 is testing earlier, preclinical disease.
06 / 07
Occurred13 Jul 2026formulation and regimen approval
Subcutaneous treatment can begin at home
FDA approves subcutaneous initiation, allowing home administration from the start. Effectiveness is bridged from IV outcomes using drug-exposure and amyloid findings, rather than a separate large subcutaneous clinical-outcome trial.
Step 6 of 7
Evidence limitations. Slower average decline is not reversal or a cure. ARIA can involve brain swelling or bleeding and can be serious or fatal; APOE ε4 homozygotes have greater risk. Approved symptomatic treatment does not establish prevention in cognitively unimpaired people.
Dated events are ordered; spacing is schematic. Undated steps have no fixed timing. · Checked Sep 13, 2026. Read the topic research