KISUNLA (donanemab-azbt)
KISUNLA is indicated for the treatment of Alzheimer's disease; Mild cognitive impairment; Mild dementia stage of Alzheimer's disease.
How KISUNLA Works
Donanemab-azbt is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody. It is directed against insoluble N-truncated pyroglutamate amyloid beta, a protein that accumulates as plaques in the brains of those with Alzheimer's disease. By targeting these specific proteins, the drug reduces the presence of amyloid beta plaques.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-07-02
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KISUNLA Approval History
What KISUNLA Treats
3 indicationsKISUNLA is approved for 3 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alzheimer's disease
- Mild cognitive impairment
- Mild dementia stage of Alzheimer's disease
KISUNLA Boxed Warning
AMYLOID RELATED IMAGING ABNORMALITIES Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events can occur. ARIA can be fatal. Serious intracerebral hemorrha...
WARNING: AMYLOID RELATED IMAGING ABNORMALITIES Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events can occur. ARIA can be fatal. Serious intracerebral hemorrhages >1 cm, some of which have been fatal, have been observed in patients treated with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with KISUNLA [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )] . ApoE ε4 Homozygotes Patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer's disease patients) treated with this class of medications, including KISUNLA, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers [see Warnings and Precautions ( 5.1 )] . Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, the risk of ARIA across genotypes and the implications of genetic testing results should be discussed with patients. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with KISUNLA; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA [see Warnings and Precautions ( 5.1 )] . Consider the benefit of KISUNLA for the treatment of Alzheimer's disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with KISUNLA [see W
KISUNLA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to KISUNLA
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05508789 | 18442 I5T-MC-AACO, 2025-522340-40-00 | Ph 3 | active not recruiting | A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) |
| NCT07571161 | 27822 I5T-MC-AACW | Ph 3 | not yet recruiting | Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease |
| NCT07167966 ATP | ATRI-014-A R01AG078457 | Ph 2 | not yet recruiting | Alzheimer's Tau Platform: Regimen A - AADvac1 |
| NCT03367403 results posted | 16933 I5T-MC-AACG | Ph 2 | completed | A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) |
| NCT05026866 | 18284 I5T-MC-AACM | Ph 3 | active not recruiting | A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) |
| NCT06911944 ALADDIN | ATRI-016 5R33AG066543 | Ph 4 | not yet recruiting | Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation |
| NCT05738486 results posted | 18648 I5T-MC-AACQ, 2022-502268-18-00 | Ph 3 | active not recruiting | A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) |
| NCT04437511 results posted | 17737 I5T-MC-AACI, 2020-000077-25 | Ph 3 | active not recruiting | A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) |
| NCT06996730 | API-2 1R01AG086363-01 | Ph 2, Ph 3 | not yet recruiting | A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease |
| NCT04640077 results posted | 17447 I5T-MC-AACH | Ph 2 | completed | A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT) |
| NCT05108922 results posted | 18369 I5T-MC-AACN | Ph 3 | completed | A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4) |
| NCT02624778 results posted | 16233 I5T-MC-AACD | Ph 1 | completed | A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD |
| NCT05567159 results posted | 18616 I5T-MC-AACP | Ph 1 | completed | A Study of Donanemab (LY3002813) in Healthy Participants |
| NCT05533411 results posted | 18244 I5T-MC-AACK | Ph 1 | completed | A Study of Donanemab (LY3002813) in Healthy Chinese Participants |
| NCT07589595 | 27790 I5T-MC-AACV | Ph 2 | not yet recruiting | A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KISUNLA FDA Label Details
Indications & Usage
FDA Label (PDF)KISUNLA is indicated for the treatment of Alzheimer's disease; Mild cognitive impairment; Mild dementia stage of Alzheimer's disease.
WARNING: AMYLOID RELATED IMAGING ABNORMALITIES Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and ti...
Explore on TheraRadar
Alzheimer's Disease Drug Landscape 2026
Disease-modifying therapies, symptomatic treatments, and clinical trial intelligence
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment