Eli Lilly is set to launch Donanemab in India after CDSCO approval for early-stage Alzheimer’s disease treatment.
- Eli Lilly is set to launch Donanemab in India after CDSCO approval
- The therapy targets amyloid-beta plaques linked to Alzheimer’s disease progression
- Researchers say earlier treatment may help slow memory and cognitive decline
India is set to receive its first disease-modifying Alzheimer’s therapy, a development many neurologists say could mark a major shift in how the country approaches early-stage dementia treatment.
Pharmaceutical company Eli Lilly is launching Donanemab injection in India under the brand name Lormalzi, following approval from the Central Drugs Standard Control Organization (CDSCO) to import and market the drug for patients with mild cognitive impairment or mild dementia in Alzheimer’s disease (1✔ ✔Trusted Source
Recommendations of the SEC (Neurology & Psychiatry) made in its 14th/25 meeting held on 26.08.2025 at CDSCO HQ New Delhi
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).
The approval was granted with a waiver for local Phase III clinical trials after the company argued that global and Asian clinical data showed no major ethnic differences in the drug’s safety or effectiveness.
Regulators also noted the growing unmet need for early Alzheimer’s treatment in India and the emergence of biomarker-based diagnostic tools capable of identifying Alzheimer’s disease at earlier stages.
However, CDSCO has directed the company to conduct a Phase IV post-marketing study in India after launch.
The launch comes at a time when Alzheimer’s disease is rapidly becoming a major public health challenge in India.
Researchers and neurologists say therapies capable of slowing disease progression — even modestly — are being closely watched because most currently available Alzheimer’s medicines mainly help manage symptoms rather than target the disease process itself.
Why Is Donanemab Being Seen as a Major Shift in Alzheimer’s Treatment?
For decades, Alzheimer’s treatment mainly focused on temporarily improving symptoms like memory problems, confusion, and difficulty performing daily tasks. But donanemab belongs to a newer class of therapies designed to target the disease process itself.
The drug is a monoclonal antibody that targets amyloid-beta plaques in the brain — one of the hallmark biological features associated with Alzheimer’s disease. Scientists believe these abnormal protein deposits gradually damage brain cells and contribute to cognitive decline over time.
Donanemab works by helping the immune system recognize and clear these amyloid plaques from the brain.
Researchers say this approach is important because Alzheimer’s disease often begins silently many years before severe dementia appears. By the time advanced symptoms develop, substantial brain damage may already have occurred.
That is why the therapy is currently intended only for patients in:
- Mild cognitive impairment due to Alzheimer’s disease
- Mild Alzheimer’s dementia
Experts say treating patients earlier may offer the best chance of slowing future decline.
The Indian approval also reflects a broader change in Alzheimer’s care. CDSCO specifically acknowledged that biomarker-based diagnostic tools for early Alzheimer’s disease are now evolving in India, making earlier diagnosis more feasible than before.
What Did the Donanemab Trials Actually Show?
The drug’s approval is based mainly on the large international TRAILBLAZER-ALZ 2 clinical trial involving patients with early symptomatic Alzheimer’s disease (2✔ ✔Trusted Source
FDA approves treatment for adults with Alzheimer’s disease
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).
The FDA (Food and Drug Administration) reported that the Phase III trial included 1,736 patients with mild cognitive impairment or mild dementia stages of Alzheimer’s disease. Patients receiving donanemab showed significantly slower clinical decline compared with placebo over 76 weeks.
Researchers measured changes using multiple cognitive and functional scoring systems that track memory, thinking ability, independence, and daily functioning.
The findings suggested that patients receiving donanemab experienced slower worsening of:
- Memory decline
- Cognitive function
- Daily activities
- Overall dementia progression
A long-term extension analysis published in The Journal of Prevention of Alzheimer’s Disease later suggested that these benefits may continue beyond the original treatment period (3✔ ✔Trusted Source
Donanemab in early symptomatic Alzheimer’s disease: results from the TRAILBLAZER-ALZ 2 long-term extension
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).Researchers found that:
- Clinical benefits continued over three years
- Disease progression remained slower in treated participants
- More than 75% of patients achieved amyloid plaque clearance
- No major new safety concerns emerged over longer follow-up
One feature that researchers say makes Donanemab different is its “limited-duration dosing” approach. In the trial, some patients were switched off active treatment after amyloid plaque levels fell below predefined PET scan thresholds.
Researchers say this strategy may help reduce unnecessary long-term treatment exposure and potentially lower future costs.
To help better understand the trial findings, the table below summarizes the key observations reported across the FDA review and long-term extension studies.
Key Findings from Donanemab Clinical Trials
| Trial Observation | Why It Matters |
|---|---|
| Donanemab slowed cognitive decline in early Alzheimer’s patients | Suggests the drug may delay the worsening of memory and thinking ability |
| Benefits continued over three years in extension studies | Indicates longer-term slowing of disease progression |
| More than 75% of treated patients achieved amyloid plaque clearance | Shows the drug effectively reduced amyloid buildup in many participants |
| Some participants were switched off treatment after plaque reduction | May reduce long-term treatment burden and exposure |
| Treatment was given as a monthly infusion | Requires less frequent dosing than some other Alzheimer’s therapies |
| MRI monitoring was required during treatment | Highlights the need for careful safety monitoring |
Source: FDA prescribing information (4✔ ✔Trusted Source
HIGHLIGHTS OF PRESCRIBING INFORMATION
Go to source
) and TRAILBLAZER-ALZ 2 extension study (3✔ ✔Trusted Source
Donanemab in early symptomatic Alzheimer’s disease: results from the TRAILBLAZER-ALZ 2 long-term extension
Go to source
).
Researchers caution that Donanemab is not a cure for Alzheimer’s disease and cannot reverse damage that has already occurred in the brain. Instead, the therapy appears to modestly slow future decline in selected early-stage patients.
Why Are Doctors Closely Watching Side Effects?
One of the biggest concerns surrounding anti-amyloid Alzheimer’s therapies involves a complication known as ARIA — amyloid-related imaging abnormalities.
According to FDA prescribing information, ARIA can involve (4✔ ✔Trusted Source
HIGHLIGHTS OF PRESCRIBING INFORMATION
Go to source):
- Brain swelling (ARIA-E)
- Small areas of brain bleeding (ARIA-H)
Most cases may remain asymptomatic, but serious and potentially life-threatening complications can occasionally occur.
The FDA warns that some people may have a higher risk of developing ARIA, especially those with certain genetic risk factors linked to Alzheimer’s disease. Because of this, doctors may recommend genetic testing before starting treatment.
MRI (magnetic resonance imaging) monitoring is also considered essential.
The FDA recommends:
- A baseline brain MRI before treatment
- Additional MRIs before the 2nd, 3rd, 4th, and 7th infusions
- Further MRI scans if neurological symptoms appear
Possible symptoms linked to ARIA may include:
- Headache
- Dizziness
- Confusion
- Visual changes
- Nausea
In rare cases, seizures or a serious brain hemorrhage can occur.
A separate expert consensus paper published in The Journal of Prevention of Alzheimer’s Disease stressed that careful patient selection will be critical in real-world clinical practice (5✔ ✔Trusted Source
Donanemab: Appropriate use recommendations
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The recommendations advised that ideal candidates should:
- Have mild cognitive impairment or mild dementia due to Alzheimer’s disease
- Show biomarker-confirmed amyloid pathology
- Undergo MRI screening
- Receive genetic testing before treatment
Experts also recommended avoiding treatment in patients with:
- Multiple brain micro bleeds
- Significant vascular brain disease
- Severe white matter disease
- Certain bleeding risks
Researchers say these precautions are especially important because anti-amyloid therapies represent an entirely new treatment model for Alzheimer’s disease, requiring long-term monitoring and coordinated neurological care.
Why Could Alzheimer’s Become an Even Bigger Challenge for India?
India is facing a rapidly growing dementia burden as its population ages.
Recent estimates suggest dementia currently affects around 8.8 million people in India, with Alzheimer’s disease accounting for the majority of cases. Researchers project this number could nearly double by 2036.
But experts say the disease affects far more than patients alone.
A nationally representative study published in Alzheimer’s & Dementia found that caregivers of cognitively impaired individuals in India experienced (6✔ ✔Trusted Source
Dementia caregiving in India: New evidence from a National representative sample
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- Higher stress levels
- Poorer mental health
- Lower emotional well-being
- Greater psychological strain
Researchers found that caregiving burdens often intensified as cognitive impairment worsened, particularly in India’s family-centered caregiving systems where relatives commonly provide most dementia care at home.
At the same time, experts warn that introducing therapies like donanemab in India may come with major practical challenges.
These include:
- High treatment costs
- Need for repeated MRI scans
- Limited access to amyloid PET imaging
- Requirement for biomarker testing
- Need for specialized neurological monitoring
Doctors say the treatment may initially remain accessible mainly to selected patients in larger urban centers with advanced neurological facilities.
Still, many neurologists believe the approval represents an important milestone because it signals a broader shift in Alzheimer’s care — from only managing symptoms toward trying to slow the underlying disease process itself.
For patients and families facing Alzheimer’s disease, experts say even modest slowing of decline may matter greatly. Preserving memory, independence, and daily functioning for a longer period can significantly affect both quality of life and caregiver burden.
While researchers stress that much remains uncertain about the long-term future of anti-amyloid therapies, many believe India’s approval of donanemab marks the beginning of a new and closely watched phase in Alzheimer’s treatment.
Frequently Asked Questions
Q:Â Who can receive Donanemab treatment?
A: The therapy is currently intended for people with mild cognitive impairment or early-stage Alzheimer’s dementia.
Q:Â What is Donanemab?
A: Donanemab is a monoclonal antibody therapy designed to remove amyloid-beta plaques linked to Alzheimer’s disease progression.
Q: Is Donanemab a cure for Alzheimer’s disease?
A:Â No. Researchers say the drug may slow disease progression but cannot reverse brain damage that has already occurred.
Q:Â Why is Donanemab considered important?
A: Unlike older Alzheimer’s medicines that mainly manage symptoms, Donanemab targets the underlying disease process itself.
Q:Â What are the possible side effects of Donanemab treatment?
A:Â Researchers say Donanemab can sometimes cause brain swelling or small brain bleeds, known as ARIA, which may require MRI monitoring during treatment.
References:
- Recommendations of the SEC (Neurology & Psychiatry) made in its 14th/25 meeting held on 26.08.2025 at CDSCO HQ New Delhi: – (https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Neurology%20Psychiatry%2026.08.2025.pdf)
- FDA approves treatment for adults with Alzheimer’s disease – (https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease)
- Donanemab in early symptomatic Alzheimer’s disease: results from the TRAILBLAZER-ALZ 2 long-term extension – (https://www.sciencedirect.com/science/article/pii/S2274580725003875)
- Highlights Of Prescribing Information – (https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf)
- Donanemab: Appropriate use recommendations – (https://pmc.ncbi.nlm.nih.gov/articles/PMC12180672/)
- Dementia caregiving in India: New evidence from a National representative sample – (https://pmc.ncbi.nlm.nih.gov/articles/PMC12079535/)
Source-Medindia