Disease-modifying therapies in Alzheimer's, as of Q2 2026
Two anti-amyloid antibodies have traditional FDA approval; subcutaneous formulations are advancing; the post-amyloid pipeline is portfolio-shaped.
A factual snapshot of where disease-modifying Alzheimer's therapy stands in mid-2026. This is a reference page - updated when material changes occur - not an analytic argument.
Approved disease-modifying therapies
- Lecanemab (Leqembi, Eisai/Biogen) - IV infusion every two weeks. Traditional FDA approval. Indicated for mild cognitive impairment and mild Alzheimer's dementia with confirmed amyloid pathology. Subcutaneous formulation submitted to regulators.
- Donanemab (Kisunla, Eli Lilly) - IV infusion every four weeks. Traditional FDA approval. Same eligibility framing as lecanemab. Distinguishing feature: amyloid-clearance-based stopping rule allows finite-duration treatment courses. Subcutaneous formulation in late development.
- Aducanumab (Aduhelm, Biogen) - Voluntarily withdrawn by sponsor in 2024.
Symptomatic therapies still in use
Cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and the NMDA receptor antagonist memantine remain part of the clinical toolkit. These are symptomatic, not disease-modifying. Their role alongside anti-amyloid therapy is generally additive in clinical practice.
Coverage and access
Anti-amyloid antibodies are covered under Medicare's coverage-with-evidence-development framework, requiring registry participation. Practical access is constrained by infusion capacity, MRI surveillance throughput, and specialist availability - discussed in our Insight on the rate-limited rollout.
What is not yet approved
No tau-directed therapy is approved. No anti-inflammatory mechanism is approved. GLP-1 agonists are not approved for Alzheimer's, with phase 3 readouts on semaglutide imminent. No combination disease-modifying regimen is approved.
What is changing in the near term
The next material changes in this landscape are most likely to be subcutaneous formulation approvals, the GLP-1 readout, and APOE4-stratified labeling refinements. None of these would change the mechanism category - they would change the delivery format, the patient population, and the precision of eligibility.
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Key sources
- FDA prescribing information - Leqembi (lecanemab)
- FDA prescribing information - Kisunla (donanemab)
- Eisai/Biogen and Eli Lilly pipeline disclosures
- ClinicalTrials.gov registered Alzheimer's programs