2024 Approvals

Kisunla: A Promising New Treatment for Alzheimer’s Disease Approved on July 2, 2024

Jasmine C

19 Aug 2025 — 1 min read

Kisunla

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What is it prescribed for?

Kisunla is indicated for the treatment of Alzheimer’s disease.

What is the name of the drug and what does it do?

Kisunla (pronounced kih-SUHN-lah), (generic name: donanemab-azbt), is a medication indicated for the treatment of Alzheimer’s disease. It is specifically for people with mild cognitive impairment or mild dementia who have confirmed amyloid pathology, meaning accumulation of amyloid proteins in the brain. Kisunla is given as an intravenous infusion every four weeks.

How does it work?

Kisunla is an amyloid beta-directed antibody. It targets and binds to amyloid beta plaques in the brain, which are believed to contribute to the progression of Alzheimer’s disease.

By binding to these plaques, Kisunla helps reduce their accumulation, potentially slowing the progression of the disease and improving cognitive function.

What did the research discover?

Clinical trials have shown that Kisunla significantly reduces amyloid beta plaque levels in the brain, as demonstrated by amyloid PET imaging. In the primary study, patients treated with Kisunla showed a reduction in amyloid plaques starting at Week 24 and continuing through Week 76.

Additionally, patients exhibited less clinical decline on cognitive and functional measures compared to those receiving a placebo.

What are some of the side effects?

ARIA-E (Amyloid Related Imaging Abnormalities - Edema)
ARIA-H microhemorrhage (small brain bleeds)
ARIA-H superficial siderosis (iron deposits in the brain)
Headache
Infusion-related reactions

Serious side effects can include severe ARIA, hypersensitivity reactions, and serious infusion-related reactions.

What are the dosage recommendations and how is it prescribed?

Kisunla is administered as an intravenous infusion. The recommended dosage is 700 mg every four weeks for the first three doses, followed by 1400 mg every four weeks.

Prior to treatment, the presence of amyloid beta pathology must be confirmed. Patients should also undergo regular MRI scans to monitor for ARIA.

Source:

Sun Pharmaceutical Industries, Inc. Kisunla (donanemab-azbt) injection, for intravenous use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217900s000lbl.pdf

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