# Leqembi Alzheimer’s drug approvals > Live situation record from CLSTR: https://clstr.news/situations/leqembi-alzheimers-drug-approvals > Updated: 2026-08-05T04:47:50.000Z. Sources: 2. Developments: 2. In July 2026 the U.S. Food and Drug Administration cleared a subcutaneous, at‑home starter dose of Leqembi (lecanemab), allowing patients or caregivers to administer the first injection outside a clinic. The approval was based on data showing bioequivalence to the intravenous regimen and was expected to improve access in the United States. A few weeks later, in early August 2026, Japan’s Eisai obtained marketing authorisation from India’s Central Drugs Standard Control Organisation and launched Leqembi as the country’s first disease‑modifying therapy for early‑stage Alzheimer’s disease. The Indian rollout highlighted the drug’s potential to slow cognitive decline, while also noting challenges such as early diagnosis, biomarker testing, infusion infrastructure and reimbursement. Together, the two events illustrate the expanding regulatory rollout of Leqembi across major markets, moving from a new at‑home dosing option in the United States to its first introduction as a disease‑modifying treatment in India. ## Timeline ### 2026-08-05: Eisai launches Leqembi in India, introducing first disease-modifying Alzheimer’s treatment Eisai has launched Leqembi in India after CDSCO approval, offering the country's first disease‑modifying therapy for early Alzheimer’s, targeting patients with MCI or mild dementia and requiring amyloid‑beta‑bi 2 sources. https://clstr.news/cluster/eisai-launches-leqembi-in-india-introducing-first-disease-modifying-alzheimers-treatment ### 2026-07-12: U.S. FDA approves at‑home starter dose of Leqembi for Alzheimer’s The U.S. FDA approved a subcutaneous at‑home starter dose of Leqembi, enabling self‑injection for Alzheimer’s patients and showing bioequivalence to IV dosing. 6 sources. https://clstr.news/cluster/us-fda-approves-athome-starter-dose-of-leqembi-for-alzheimers --- Cite as: Leqembi Alzheimer’s drug approvals. CLSTR, https://clstr.news/situations/leqembi-alzheimers-drug-approvals