Drug Therapies for Alzheimer’s-Type Dementia

The two most recently FDA-approved disease-modifying therapies for Alzheimer's disease — lecanemab (Leqembi) and donanemab (Kisunla) — have already received traditional FDA approval (lecanemab in July 2023, donanemab in July 2024) and are now available for clinical use. As of August 2025, these agents have been approved in 45 countries. Beyond these, several agents are in late-stage development or approaching regulatory review.

Currently FDA-Approved Anti-Amyloid Monoclonal Antibodies

• Lecanemab (Leqembi): Targets soluble Aβ protofibrils; administered IV every 2 weeks. The CLARITY-AD phase 3 trial demonstrated a 27% slowing of cognitive and functional decline (CDR-SB) at 18 months versus placebo.
• Donanemab (Kisunla): Targets N-terminal pyroglutamate Aβ in established plaques; administered IV every 4 weeks with a "treat-to-clear" model. The TRAILBLAZER-ALZ 2 phase 3 trial showed ~35% slowing of decline in the low/medium tau population. Both agents carry risks of amyloid-related imaging abnormalities (ARIA), with ARIA-E rates of ~12–24% and treatment-related deaths reported in both trials.

Agents in Late-Stage (Phase 3) Development

• Remternetug (Eli Lilly): Another anti-amyloid monoclonal antibody currently in a phase 3 trial with completed enrollment. It targets pyroglutamate Aβ similarly to donanemab but with potentially higher potency and subcutaneous administration. A Cochrane review from April 2026 identified remternetug among the ongoing late-stage amyloid-targeting antibody trials. An FDA submission may be anticipated based on trial readouts.
• Combination anti-Aβ + anti-tau therapy: At least one phase 3 trial (NCT05269394) is evaluating a combined anti-amyloid and anti-tau monoclonal antibody approach, reflecting a shift toward targeting multiple pathological mechanisms simultaneously.

Emerging Pipeline (Phase 2 Advancing Toward Phase 3)