New Delhi, November 18, 2025 – Eli Lilly and Company (India) Pvt. Ltd. today announced that the Central Drugs Standard Control Organization (CDSCO) has granted marketing authorization for donanemab (350 mg/20 mL administered every four weeks via intravenous infusion as described in the prescribing information) for the treatment of Alzheimer’s disease (AD) in adults with early symptomatic stages. This includes individuals with mild cognitive impairment (MCI) and those in the mild dementia stage of AD, with confirmed amyloid pathology.1,2

Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease.3,4 Donanemab is a disease modifying drug that helps the body remove excessive buildup of amyloid plaques and slows the cognitive and functional decline that may diminish people’s ability to remember new information, important dates, and appointments; plan and organize; make meals; use household appliances; manage finances; and be left alone.3-6

“The approval of donanemab marks a significant milestone in our mission to address the urgent needs of people living with Alzheimer’s disease in India,” said Winselow Tucker, president and general manager, Lilly India. “By offering an innovative therapy that targets amyloid plaques and slows cognitive decline, we aim to give patients and their families more time and a better quality of life.7 This underscores Lilly’s commitment to delivering innovative treatments in India to those who need them most.”

Alzheimer’s disease is the most common cause of dementia globally, accounting for 60–70% of cases.8 However, currently, it is highly underdiagnosed. India, with its rapidly aging population, faces a growing health challenge: it is estimated that by 2030, over 8 million people in India will be living with dementia, with Alzheimer’s disease representing the largest share of cases.9 Early diagnosis and treatment are critical to improving patient outcomes and easing the significant burden on families and caregivers.