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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.
How quickly does amyloid reaccumulate after completion of Kisunla® (donanemab-azbt) treatment?
Among participants who completed donanemab treatment by 52 weeks, mean amyloid levels remained below 24.1 CL at 3 years. The rate of amyloid reaccumulation is estimated to be 2.40 CL/year, based on a modeling analysis.
See important safety information, including boxed warning, in the attached prescribing information.
Amyloid Reaccumulation After Donanemab Treatment Completion
TRAILBLAZER-ALZ 2 Study
In the phase 3 TRAILBLAZER-ALZ 2 study, completion of active treatment in the clinical trial was guided by amyloid positron emission tomography (PET) levels measured at week 24 and week 52. Participants were eligible to be switched to placebo if the amyloid plaque level was
- <11 centiloids (CL) on a single PET scan, or
- 11 to <25 CL on 2 consecutive PET scans.1
An analysis was conducted in 111 donanemab-treated participants in the TRAILBLAZER-ALZ 2 study who
- achieved amyloid plaque levels below 11 CL by 24 weeks and switched to placebo, and
- completed an amyloid PET scan at week 76.2
These participants had
- a baseline mean amyloid plaque level of 80.76 CL (compared with 104.0 CL for overall donanemab-treated population), and
- a mean reduction from baseline of 83.18 CL at 24 weeks and 82.93 CL at 76 weeks.2
There was no substantial amyloid reaccumulation from 24 weeks to 76 weeks, with a median amyloid reaccumulation of 0.95 CL (first quartile -4.50 CL, third quartile 4.63 CL) in these participants.2
TRAILBLAZER-ALZ 2 Long-Term Extension Study
In the long-term extension of the TRAILBLAZER-ALZ 2 study, the mean amyloid level was 10.99 CL (SD 14.41 CL) at 3 years among participants who had met donanemab treatment course completion criteria by week 52 of the placebo-controlled period.3
A small subgroup of participants (n=34/195) who met treatment course completion criteria by week 52 had an amyloid level ≥24.1 CL at week 154. A higher amyloid level at 52 weeks was significantly associated with higher amyloid at week 154. However, baseline characteristics associated with conversion to amyloid positivity in natural accumulation, including age, sex, apolipoprotein E ε4 status, and cognitive score, showed no significant association with reaching an amyloid level ≥24.1 CL at week 154.4,6
Modeling 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.3
This finding is supported by natural amyloid accumulation modeling studies, showing approximately 3 CL/year estimated natural rate of amyloid accumulation.4,5
Enclosed Prescribing Information
KISUNLA® (donanemab-azbt) injection, for intravenous use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Sims 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
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Zimmer JA, Sims JR, Evans CD, et al. 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
- Jagust WJ, Landau SM; Alzheimer's Disease Neuroimaging Initiative. Temporal dynamics of β-amyloid accumulation in aging and Alzheimer disease. Neurology. 2021;96(9):e1347-e1357. https://doi.org/10.1212/wnl.0000000000011524
- Elhefnawy ME, Patson N, Mouksassi S, et al. Quantifying natural amyloid plaque accumulation in the continuum of Alzheimer's disease using ADNI. J Pharmacokinet Pharmacodyn. 2025;52(1):15. https://doi.org/10.1007/s10928-024-09959-y
- Shcherbinin 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 and Parkinson's Diseases and Related Neurological Disorders (AD/PD); March 17-21, 2026; Copenhagen, Denmark.
Date of Last Review: August 17, 2026