Eli Lilly and Company (India) Pvt. Ltd. has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) for donanemab, a treatment for adults in the early symptomatic stages of Alzheimer’s disease. The approval covers patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s, with confirmed amyloid pathology. The therapy is administered as a 350 mg/20 mL intravenous infusion every four weeks.

Donanemab is designed to help remove excessive amyloid plaque buildup in the brain — a key driver of cognitive decline in Alzheimer’s. By targeting and clearing these plaques, the medicine slows the progression of memory loss and functional decline that affect daily activities such as planning, organizing, managing finances, or remembering appointments.

Winselow Tucker, president and general manager of Lilly India, said the approval represents a major step toward addressing the growing burden of Alzheimer’s in the country.

With India projected to have over 8 million people living with dementia by 2030, early diagnosis and timely treatment are becoming increasingly critical. Donanemab, however, can cause serious side effects, including amyloid-related imaging abnormalities (ARIA) and infusion-related reactions.