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Kisunla ™ (donanemab-azbt) injection, for intravenous infusion
350 mg/20 mL (17.5 mg/mL)
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the optimum duration of treatment with Kisunla® (donanemab-azbt)?
Course of therapy with donanemab may be completed when amyloid plaques are reduced to minimal levels as indicated by amyloid PET imaging. Data supports assessing response to treatment after 12 months.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
Use Clinical Judgment When Considering Donanemab Treatment Course
Consider completing course of therapy with donanemab based on reduction of amyloid plaques to minimal levels on amyloid PET imaging.1Clinical judgment should be used when considering whether an individual patient’s course of therapy should be continued or completed in the absence of a safety issue. Clinical judgment may be informed by factors such as clinical assessments and amyloid beta pathology.
Completing Course of Treatment in the TRAILBLAZER-ALZ 2 Study
The TRAILBLAZER-ALZ 2 study was designed to allow for the treatment course to be completed prior to the end of the 76-week trial if participants reached a prespecified level of amyloid plaque reduction. Participants were eligible to be switched from donanemab to placebo if they met treatment course completion criteria, defined as amyloid plaque levels
Additional details about the TRAILBLAZER-ALZ 2 Study Design are available in the Appendix.
Course of therapy was continued or completed in response to observed effects on amyloid imaging in the TRAILBLAZER-ALZ 2 study. The percentages of donanemab-treated participants who were eligible to be switched to placebo based on amyloid PET levels were
In TRAILBLAZER-ALZ 2, amyloid plaque was considered to be reduced to minimal levels when the amyloid plaque level was <24.1 CL on amyloid PET, which is consistent with a visually negative read of an amyloid PET scan.2,3
The percentages of donanemab-treated participants who met this threshold on amyloid PET were
- 30% at week 24
- 66% at week 52, and
- 76% at week 76.2
A post hoc analysis of the TRAILBLAZER-ALZ 2 study shows that in participants who were eligible to be switched to placebo, the treatment effect persists after dose cessation (Treatment Effect Persists in Donanemab Participants Meeting Criteria for Therapy Course Completion as Measured by iADRS and CDR-SB).4
Figure 1 description: Donanemab treatment effect continues to widen even after participants are switched to placebo based on 6- or 12-month PET scan. The mean time in trial prior to switching to placebo for these participants was 47 weeks.
Abbreviations: CDR-SB = Clinical Dementia Rating–Sum of Boxes; iADRS = Integrated Alzheimer's Disease Rating Scale; NCS = natural cubic spline; PET = positron emission tomography.
Notes: iADRS and CDR-SB used the NCS model with 2 degrees of freedom adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline acetylcholinesterase inhibitor/memantine use. Participants that did not complete course of treatment were also included in the model but are not plotted here.
Nominal p-values: ** p<.01, *** p<.001, **** p<.0001.
The Appendix provides a description of the study populations by tau PET level at baseline.
TRAILBLAZER-ALZ 2 Long-Term Extension
Participants who completed the placebo-controlled period of the TRAILBLAZER-ALZ 2 study were eligible to enter a 78-week double-blind long-term extension. Early start participants were those initially randomized to donanemab in the placebo-controlled period. Participants from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) were selected as external control.5
In the long-term extension, a growing treatment effect was observed for early start participants who met treatment course completion criteria by 52 weeks of the placebo-controlled period, with an adjusted mean treatment difference of −1.3 points (95% CI, −1.9 to −0.7) in the Clinical Dementia Rating–Sum of Boxes (CDR-SB) score between donanemab and the external weighted ADNI control cohort at 3 years (Treatment Effect Continued to Grow 2 Years Beyond Treatment Completion as Measured by CDR-SB).5
Figure 2 description: Early-start participants who met the treatment course completion criteria by 52 weeks in the placebo-controlled period showed a growing treatment effect for up to 3 years compared to an untreated population.
Abbreviations: ADNI = Alzheimer’s Disease Neuro Imaging Initiative; CDR-SB = Clinical Dementia Rating–Sum of Boxes; ESS = effective sample size; PC = placebo-controlled; LTE = long-term extension.
* Early-start participants that met treatment completion criteria by 52 weeks.
# Mean time to switch to placebo is 47 weeks.
Of participants initially randomized to donanemab in the placebo-controlled period, 85% met criteria to complete the course of donanemab therapy based on amyloid PET criteria within 3 years.7
Among participants who did not meet treatment course completion criteria by 76 weeks and continued donanemab treatment in the LTE period (N=157), 56.8% achieved amyloid plaque reduction to minimal levels at 154 weeks.8
In participants who had met donanemab treatment course completion criteria by week 52 of the placebo-controlled period, the mean amyloid level was 10.99 CL (standard deviation 14.41 CL) at 3 years.5
Among the subset of patients who met treatment course completion at week 52 of the placebo-controlled period (n=126), 82% had amyloid levels below 24.1 CL at 3 years.7
Modelling Studies Predicting Amyloid Reaccumulation
Changes in individual donanemab trial participant amyloid plaque trajectories were used to inform a model to predict the rate of amyloid reaccumulation during an off-treatment period. Using a scenario with a post-treatment baseline amyloid level <11 CL in the model, the simulations estimated a median amyloid reaccumulation rate of 2.40 CL/year off treatment.5
Assessing Response to Donanemab Treatment
Evaluation of Maintenance Dosing
As a US post-marketing commitment, Lilly will study maintenance dosing for donanemab following completion of our TRAILBLAZER-ALZ 3 preclinical Alzheimer’s disease clinical trial.10
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2Sims JR, Zimmer JA, Evans CD, et al; TRAILBLAZER-ALZ 2 Investigators. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023;330(6):512-527. https://doi.org/10.1001/jama.2023.13239
3Navitsky M, Joshi AD, Kennedy I, et al. Standardization of amyloid quantitation with florbetapir standardized uptake value ratios to the Centiloid scale. Alzheimers Dement. 2018;14(12):1565-1571. https://doi.org/10.1016/j.jalz.2018.06.1353
4Sims JR. Donanemab in early symptomatic Alzheimer’s disease: clinical efficacy results from TRAILBLAZER-ALZ 2. Poster presented at: Alzheimer's Association International Conference (AAIC); July 16-20, 2023; Amsterdam, Netherlands.
5Zimmer JA, Sims JR, Evans CD, et al; Alzheimer’s Disease Neuroimaging Initiative. Donanemab in early symptomatic Alzheimer's disease: results from the TRAILBLAZER-ALZ 2 long-term extension. J Prev Alzheimers Dis. 2026;13(2):100446. https://doi.org/10.1016/j.tjpad.2025.100446
6Zimmer JA. Donanemab in early symptomatic Alzheimer's disease: additional insights from the TRAILBLAZER‐ALZ 2 long-term extension. Poster presentation at: Clinical Trials on Alzheimer's Disease (CTAD); December 1-4, 2025; San Diego, California, USA.
7Data on file, Eli Lilly and Company and/or one of its subsidiaries.
8Shcherbinin S, Zimmer JA, Wang H, et al. Amyloid trajectories after donanemab treatment: 3-year data from TRAILBLAZER-ALZ 2. Poster presented at: 20th International Conference on Alzheimer's Disease and Parkinson's Disease (ADPD). March 17-21, 2026.
9Collins EC. Insights from TRAILBLAZER-ALZ 2 (Donanemab): limited duration dosing. Presented as an oral presentation at: Alzheimer's Association International Conference (AAIC); July 28-August 1, 2024; Philadelphia, USA. Accessed March 5, 2026. https://assets.ctfassets.net/mpejy6umgthp/4Xzve6Up2kj9uvvfskAJ3D/c9dfd30ccc0a449c80b35ef761e5fe41/VV-DONPT3_AAIC2024_ZIMMER_TRLBL_ALZ-2_INSIGHTS_DV-024669_V7.4.pdf
10Center for Drug Evaluation and Research; US Food and Drug Administration. Approval letter Kisunla BLA 761248. July 2, 2024. Accessed March 5, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000Approv.pdf
11Solomon PR. TRAILBLAZER-ALZ 2: clinical background and study design. Abstract presented at: Alzheimer's Association International Conference (AAIC); July 16-20, 2023; Amsterdam, Netherlands.
Appendix
TRAILBLAZER-ALZ 2 Study Design
The safety and efficacy of donanemab were evaluated in TRAILBLAZER-ALZ 2, a phase 3, placebo-controlled 76-week study. This study enrolled adults aged 60 to 85 years with early symptomatic Alzheimer's disease (AD), defined as
- prodromal AD, the symptomatic phase of AD in which mild cognitive impairment is apparent, or
- AD with mild dementia, in which symptoms are sufficiently severe to meet diagnostic criteria for dementia.2
Eligible participants had
- a Mini-Mental State Examination (MMSE) score of 20 to 28 (scores range from 0 to 30, with higher scores indicating better mental performance), and
- presence of amyloid pathology assessed by amyloid PET imaging (≥37 CL) with either florbetapir F 18 or florbetaben F 18, and tau pathology assessed by flortaucipir F 18 PET imaging.2
Definitions of Populations by Baseline Tau PET Levels
Population Analyzed | Description |
Low/medium tau | Population including participants with baseline
|
High tau | Population including participants with baseline SUVr >1.46 and a topographic deposition pattern consistent with either moderate or advanced AD neuropathology. |
Overall population | Population including participants with both low/medium tau and high tau levels. |
Abbreviations: AD = Alzheimer's disease; PET = positron emission tomography; SUVr = standard uptake value ratio.
Date of Last Review: February 12, 2026