Donanemab 350mg/20mL Injection — Anti-Amyloid Monoclonal Antibody for Early Symptomatic Alzheimer’s Disease
Lormalzi® (Donanemab) — Anti-Amyloid Therapy for Early Alzheimer’s Disease
A Sourcing Guide for Hospitals and Neurology Centres
Lormalzi® (Donanemab) is a humanised IgG1 monoclonal antibody indicated, according to its approved prescribing information, for the treatment of adults with early symptomatic Alzheimer’s disease, including patients with mild cognitive impairment or mild dementia stage of disease, with confirmed amyloid pathology. As with all disease-modifying Alzheimer’s therapies, the decision to prescribe Lormalzi, including amyloid confirmation testing and ongoing MRI monitoring, rests entirely with the treating neurologist, in accordance with the approved label. This page provides sourcing and procurement information for hospitals and pharmacies, not clinical or treatment guidance.
As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supplies genuine Lormalzi (Donanemab) 350mg/20mL to hospitals, neurology centres, and pharmacies across India, manufactured by Eli Lilly and Company.
Lormalzi contains Donanemab, a humanised monoclonal antibody directed against insoluble, N-truncated pyroglutamate amyloid beta, a specific form of amyloid that accumulates in the brains of patients with Alzheimer’s disease.
Amyloid Plaques and Alzheimer’s Disease Pathology:
According to published neurology literature, one of the defining pathological hallmarks of Alzheimer’s disease is the progressive accumulation of amyloid beta plaques in the brain, which are believed to interfere with normal neuronal communication and contribute to the neurodegeneration underlying cognitive decline. Unlike earlier symptomatic treatments for Alzheimer’s disease, which primarily manage symptoms without addressing this underlying pathology, Donanemab is classified as a disease-modifying therapy, designed to directly target and reduce amyloid plaque burden in the brain.
Donanemab’s Mechanism: By binding specifically to a modified, pyroglutamate form of amyloid beta found within existing plaques, Donanemab is believed to facilitate microglia-mediated clearance of amyloid plaques from the brain, according to the manufacturer’s prescribing information. This targeted approach to an already-aggregated form of amyloid distinguishes its binding profile from some other anti-amyloid antibodies that target different forms of the protein.
Full prescribing information is available at the FDA label for Donanemab, with additional background on Alzheimer’s disease pathology available via the National Institute on Aging.
TRAILBLAZER-ALZ 2 Trial (Donanemab in Early Symptomatic Alzheimer’s Disease)
Published in the Journal of the American Medical Association (2023), the pivotal TRAILBLAZER-ALZ 2 trial evaluated Donanemab in patients with early symptomatic Alzheimer’s disease, with amyloid and tau pathology confirmed by PET imaging. Key findings included a statistically significant slowing of clinical decline compared to placebo over the 76-week study period, as measured by a validated integrated Alzheimer’s disease rating scale, along with substantial reduction in amyloid plaque burden on PET imaging. This trial formed the basis for regulatory approval.
TRAILBLAZER-ALZ 6 Trial (Modified Titration Dosing Schedule)
This Phase 3b trial evaluated an alternative, more gradual dose-titration schedule for Donanemab, comparing it against the original regimen in patients with early symptomatic Alzheimer’s disease. The modified titration schedule significantly reduced the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at 24 and 52 weeks, while achieving amyloid plaque reduction and P-tau217 reduction comparable to the original dosing schedule. This trial supported the FDA’s approval of an updated, safer titration schedule in July 2025.
For broader clinical guidance on Alzheimer’s disease diagnosis and management, the Alzheimer’s Association publishes ongoing clinical guidance.
Lormalzi is supplied as:
| Presentation | Strength | Administration |
|---|---|---|
| Lormalzi Injection | 350mg/20mL single-dose vial | Intravenous infusion, once every 4 weeks |
Approved Titration Dosing Schedule (per current prescribing information):
| Infusion | Dose |
|---|---|
| Infusion 1 | 350mg |
| Infusion 2 | 700mg |
| Infusion 3 | 1050mg |
| Infusion 4 and thereafter | 1400mg |
This gradual titration schedule was adopted following TRAILBLAZER-ALZ 6 data demonstrating a meaningfully lower incidence of ARIA-E compared to the original dosing schedule, while achieving comparable amyloid plaque reduction.
Early Symptomatic Alzheimer’s Disease:
Amyloid confirmation testing, using an approved diagnostic method, is required before initiating Lormalzi therapy, per the approved prescribing information.
For detailed indication information refer to MedlinePlus Alzheimer’s Disease.
Disease-Modifying Mechanism
Unlike symptomatic Alzheimer’s treatments, Lormalzi is designed to directly reduce amyloid plaque burden in the brain, targeting one of the underlying pathological hallmarks of the disease rather than only managing symptoms.
Demonstrated Slowing of Clinical Decline
TRAILBLAZER-ALZ 2 demonstrated a statistically significant slowing of clinical decline compared to placebo over 76 weeks in patients with early symptomatic Alzheimer’s disease.
Improved Safety Profile With Updated Titration
The modified titration schedule adopted following TRAILBLAZER-ALZ 6 significantly reduces the incidence of ARIA-E compared to the original dosing regimen, while preserving comparable amyloid-lowering effect — a meaningful advancement in balancing efficacy and tolerability.
Once-Monthly Infusion Schedule
Administered once every 4 weeks, Lormalzi’s dosing interval is designed to be manageable for patients and caregivers navigating an early-stage cognitive condition.
Dosing of Lormalzi is determined by the prescribing neurologist according to the approved label. General administration information from the manufacturer’s prescribing information includes:
Monitoring (per manufacturer prescribing information):
Full dosing guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating neurologist.
Lormalzi is prescribed by neurologists for:
Lormalzi is prescribed by neurologists and memory care specialists managing early-stage Alzheimer’s disease. A.K. Pharma supplies Lormalzi to hospitals and neurology centres across Delhi and India.
Common side effects reported in clinical trials include infusion-related reactions and amyloid-related imaging abnormalities.
Serious side effects include:
Amyloid-Related Imaging Abnormalities (ARIA): A Boxed Warning addresses the risk of ARIA, which includes ARIA-E (edema/effusion) and ARIA-H (microhemorrhage/hemosiderin deposits), detectable on MRI. Regular MRI monitoring at specified intervals is required per the approved prescribing information, with dosing decisions dependent on clinical symptoms and radiographic severity if ARIA occurs.
Infusion-Related Reactions: Reported during and following intravenous administration; monitoring during infusion is recommended per standard clinical protocol.
Hypersensitivity Reactions: Reported with this therapeutic class; prompt recognition and management guidance is provided in the approved prescribing information.
Full side effect information is available at FDA Donanemab Safety Information.
As a responsible medicine distributor in Delhi, A.K. Pharma stores all neurology biologics including Lormalzi under manufacturer-recommended cold chain conditions ensuring product integrity for every supply.
Lormalzi (Donanemab) is manufactured by Eli Lilly and Company, and is the Indian brand of Donanemab, the same active ingredient as the internationally recognised Kisunla. Donanemab received FDA approval in July 2024 for early symptomatic Alzheimer’s disease, with an updated titration dosing schedule approved in July 2025. Lormalzi was launched in India in May 2026, receiving marketing authorisation from India’s Central Drugs Standard Control Organization for patients with mild cognitive impairment or mild dementia stages of Alzheimer’s disease. A.K. Pharma supplies only genuine Lormalzi sourced from authorised distributors.
Q. What is Lormalzi used for?
Lormalzi (Donanemab) is used to treat adults with early symptomatic Alzheimer’s disease, including those with mild cognitive impairment or mild dementia, who have confirmed amyloid pathology.
Q. What is the generic name and strength of Lormalzi?
The generic name of Lormalzi is Donanemab, supplied as a 350mg/20mL single-dose vial, manufactured by Eli Lilly and Company, and equivalent to the internationally recognised Kisunla.
Q. Why does Lormalzi require MRI monitoring during treatment?
Lormalzi carries a Boxed Warning for amyloid-related imaging abnormalities (ARIA), a recognised side effect of anti-amyloid antibody therapies, which is why baseline and periodic MRI scans are required at specific points during treatment, per the approved prescribing information.
Q. Why was the dosing schedule for Donanemab updated?
Following data from the TRAILBLAZER-ALZ 6 trial, the FDA approved a more gradual titration schedule (350mg, 700mg, 1050mg, then 1400mg) that significantly reduced the incidence of ARIA-E compared to the original schedule, while maintaining comparable amyloid plaque reduction.
Q. Is Lormalzi the same as Kisunla?
Yes. Lormalzi is the Indian brand name for Donanemab, the same active ingredient sold internationally under the brand name Kisunla.
Q. Is Lormalzi available in India?
Yes. Lormalzi received marketing authorisation from India’s Central Drugs Standard Control Organization and can be supplied to hospitals and neurology centres across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi and pharmaceutical distributor in Delhi — for availability and pricing.
Q. What is the price of Lormalzi in India?
Lormalzi has been priced by the manufacturer at approximately ₹91,688 per 350mg vial. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.
Q. How to order Lormalzi from A.K. Pharma?
You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.
Q. Does A.K. Pharma supply Lormalzi in bulk?
Yes. A.K. Pharma supplies Lormalzi in bulk to hospitals and neurology centres across Delhi and India.
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Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions, including drug selection and dosing, should be made by a qualified healthcare professional in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.
