Eli Lilly Presents Kisunla (Donanemab-Azbt) Modified Titration Regimen and TRAILBLAZER-ALZ 2 Long-Term Extension Data at AAIC 2026 Wednesday July 15 Closing-Day Developing Topics Session 'Donanemab in Early Symptomatic Alzheimer's Disease: Evidence to Address Clinical Questions': The Modified Titration (350 mg Starting Dose Ramping to 1,400 mg by Week 4) Significantly Reduced ARIA-E Brain Swelling Incidence, and Long-Term Extension Data Show Patients Reaccumulate Amyloid at 2.4 Centiloid Per Year After Treatment Completion (Comparable to Natural Accumulation Rate), Supporting a 1,400 mg Once-Yearly Maintenance-Dose Investigation
Eli Lilly (NYSE: LLY) presented Kisunla (donanemab-azbt) modified titration regimen data and TRAILBLAZER-ALZ 2 long-term extension results at AAIC 2026 in London on Wednesday July 15, 2026 during the closing-day Developing Topics Session titled 'Donanemab in Early Symptomatic Alzheimer's Disease: Evidence to Address Clinical Questions.' The modified titration regimen for Kisunla used a 350 mg starting dose ramping to the standard 1,400 mg by week 4, which significantly reduced cases of ARIA-E (amyloid-related imaging abnormalities with edema) brain swelling relative to the standard titration schedule. The Phase 3 TRAILBLAZER-ALZ 2 long-term extension data documented that patients who met the criteria for ending treatment at 52 weeks maintained low amyloid levels through 154 weeks of follow-up, with an amyloid reaccumulation rate of 2.4 centiloid per year (comparable to the natural accumulation rate seen in untreated cognitively unimpaired individuals). John Sims, Eli Lilly senior medical director, framed the readout around a 1,400 mg once-yearly maintenance-dose hypothesis: 'If someone needed it, [1,400 mg once a year] could potentially keep that amyloid down and keep it low and steady.' Lilly is running an addendum study of the TRAILBLAZER-ALZ 6 trial to characterize the ability of a maintenance dose given at least a year after original treatment completion to sustain amyloid clearance.