Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 945 |
| INN | Amlenetug |
| Status | Clinical |
| Drug code(s) | Lu AF82422 |
| Brand name | None |
| mAb sequence source | mAb human |
| 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) | Alpha synuclein |
| Indications of clinical studies | Multiple System Atrophy, Parkinson's disease |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 25, 2018 |
| Start of Phase 2 | November 15, 2021 |
| Start of Phase 3 | November 15, 2024 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | H. Lundbeck A/S |
| Licensee/Partner | Genmab |
| Comments about company or candidate | Nov 27, 2024: H. Lundbeck A/S announced the advancement of the clinical development of amlenetug (Lu AF82422) for the treatment of MSA with the initiation of MASCOT, a randomized, double-blind, phase III trial. NCT06706622 Phase 3 in Multiple System Atrophy due to start in Dec 2024. Listed as Phase 2 asset in company pipeline accessed Mar 2023. NCT05104476 Phase 2 study in Multiple System Atrophy started in Nov 2021 active not recruiting as of last update in Dec 2022. NCT03611569 Phase 1 study in Parkinson's disease started in July 2018 completed in July 2021. Lu AF82422 was invented by Lundbeck in collaboration with Genmab. |
| Full address of company | Ottiliavej 9, 2500 Valby, Denmark Europe Denmark https://www.lundbeck.com/global |
Lu AF82422 is a human IgG1 mAb that recognizes all major species of alpha-synuclein. Extracellular alpha-synuclein is believed to play a major role in disease pathology and progression in Parkinson’s disease.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |