Overview
Donanemab (LY3002813) is a humanized IgG1 monoclonal antibody targeted against an epitope at the N-terminal of a specific type of amyloid beta (Aβ) - pyroglutamate Aβ - which is found only in the brain amyloid plaques associated with Alzheimer's Disease (AD). It works by inducing microglial-mediated clearance of existing Aβ plaques with the intent of slowing the progressive decline in cognitive function associated with AD. A phase II study conducted by Eli Lilly and published in March 2021 (TRAILBLAZER-ALZ), which looked at 257 patients with early symptomatic AD, found that patients receiving donanemab experienced a roughly 30% slower progression in AD as measured by a disease rating scale (iADRS), although results for secondary endpoints were mixed. In March 2021, Eli Lilly announced an expanded trial, named TRAILBLAZER-ALZ 2, which will seek to confirm the results of the first trial with an expanded patient population in order to address some of the deficiencies of the original.
Background
Donanemab (LY3002813) is a humanized IgG1 monoclonal antibody targeted against an epitope at the N-terminal of a specific type of amyloid beta (Aβ) - pyroglutamate Aβ - which is found only in the brain amyloid plaques associated with Alzheimer's Disease (AD). It works by inducing microglial-mediated clearance of existing Aβ plaques with the intent of slowing the progressive decline in cognitive function associated with AD. A phase II study conducted by Eli Lilly and published in March 2021 (TRAILBLAZER-ALZ), which looked at 257 patients with early symptomatic AD, found that patients receiving donanemab experienced a roughly 30% slower progression in AD as measured by a disease rating scale (iADRS), although results for secondary endpoints were mixed. In March 2021, Eli Lilly announced an expanded trial, named TRAILBLAZER-ALZ 2, which will seek to confirm the results of the first trial with an expanded patient population in order to address some of the deficiencies of the original.
Indication
用于治疗阿尔茨海默病。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/30 | Phase 2 | Not yet recruiting | |||
2025/04/04 | Phase 4 | Not yet recruiting | Michael Rafii, MD, PhD | ||
2024/08/22 | N/A | Recruiting | |||
2023/02/22 | Phase 3 | Active, not recruiting | |||
2022/10/05 | Phase 1 | Completed | |||
2022/09/09 | Phase 1 | Completed | |||
2022/08/19 | Phase 3 | Recruiting | |||
2021/11/05 | Phase 3 | Completed | |||
2021/08/30 | Phase 3 | Recruiting | |||
2020/11/23 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Lormalzi Concentrate for Solution for Infusion 350mg/20mL | SIN17201P | INFUSION, SOLUTION CONCENTRATE | 350mg/20mL | 3/11/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Donanemab Injection | 国药准字SJ20240047 | 生物制品 | 注射剂 | 12/17/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| KISUNLA donanemab 350 mg/20 mL concentrated solution for intravenous infusion vial | 420194 | Medicine | A | 5/21/2025 |