Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1729 |
| INN | Donanemab |
| Status | Approved |
| Drug code(s) | LY3002813, N3pG-AB mAb |
| Brand name | Kisunla |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Amyloid beta (N3pG) |
| Indications of clinical studies | Alzheimer disease |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Approved US, Japan, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2013 |
| Start of Phase 2 | December 18, 2017 |
| Start of Phase 3 | March 15, 2021 |
| Date BLA/NDA submitted to FDA | June 12, 2023 |
| Year of first approval (global) | 2024 |
| Date of first US approval | July 02, 2024 |
| INN, US product name | Donanemab, donanemab-azbt |
| US or EU approved indications | Treatment for adults with early symptomatic Alzheimer's disease and people with the mild dementia stage of AD, with confirmed amyloid pathology |
| Company | Eli Lilly and Company |
| Licensee/Partner | None |
| Comments about company or candidate | July 2, 2024: The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt) March 8, 2024: Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer's disease. Date of meeting has not been set. EMA evaluation started Aug 17, 2023. Jan 19, 2023: The U.S. Food and Drug Administration has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. No other deficiencies in the application were noted. The confirmatory Phase 3 TRAILBLAZER-ALZ 2 trial remains ongoing, with topline data read-out expected in Q2 2023, and will form the basis of donanemab's application for traditional approval shortly thereafter. October 2021: Eli Lilly has announced that they have initiated rolling submission of a biologics license application (BLA) for donanemab, an investigational antibody therapy, to the FDA for accelerated approval in early Alzheimer disease (AD). July 15, 2021: Eli Lilly and Company and Banner Alzheimer's Institute today announced a strategic research collaboration as part of the planned Phase 3, randomized, placebo-controlled study evaluating donanemab in participants at risk for cognitive and functional decline related to Alzheimer's disease (TRAILBLAZER-ALZ 3). TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer's disease in trial participants. Listed as Phase 3 in Lilly pipeline dated April 23, 2021. NCT04437511 converted into a Phase 3 study in March 2021. March 13, 2021: Phase 2 TRAILBLAZER-ALZ results presented by Eli Lilly and Company at the 15th International Conference on Alzheimer's & Parkinson Diseases™ 2021 held virtually March 9-14, 2021 and published simultaneously in the New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2100708) expand on previously reported top-line data that found donanemab met its primary endpoint and showed significant slowing of decline on the integrated Alzheimer's Disease Rating Scale (iADRS), a composite measure of cognition and daily function, in patients with early symptomatic Alzheimer's disease compared to placebo NCT04640077 Phase 2 in AD not yet recruiting when first posted on Nov 23, 2020. NCT04437511 Phase 2 study in AD not yet recruiting when first posted on June 18, 2020. Still listed in Lilly pipeline dated July 29, 2019. NCT03367403 Phase 2 study started in Dec 2017. Listed as Phase 1 in pipeline dated April 19, 2016. NCT01837641 Phase 1 study started in May 2013 |
| Full address of company | Indianapolis, Indiana, United States North America United States of America https://www.lilly.com |
None
| Anticipated events | Regulatory review EU |
| Factor(s) contributing to discontinuation | None |