Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 590 |
| INN | Etalanetug |
| Status | Clinical |
| Drug code(s) | E2814 |
| Brand name | None |
| 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) | Tau (MTBR) |
| Indications of clinical studies | Alzheimer's disease |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | December 22, 2021 |
| 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 | Eisai Inc. |
| Licensee/Partner | University College London |
| Comments about company or candidate | In September 2024, Eisai initiated a Phase II clinical study (Study 202) for individuals with early AD in the United States Phase 2/3 studies for Dominantly inherited Alzheimer's Disease (NCT05269394, NCT01760005) are recruiting as of May 12, 2023. Jan 18, 2022: Eisai Co., Ltd. announced that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has enrolled the first subject in the phase II/III study (Tau NexGen study). The study will assess the effect of Eisai's investigational anti-microtubule binding region (MTBR) tau antibody E2814, in dominantly inherited Alzheimer's disease (DIAD). NCT05269394 Phase 2/3 study started in Dec 2021 recruiting as of last update in Dec 2022. March 2021: Eisai Co., Ltd. announced that anti-microtubule binding region (MTBR) tau antibody E2814, which was created from collaboration research between Eisai and University College London, has been selected by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) led by Washington University School of Medicine in St. Louis, as the first investigational medicine among anti-tau drugs for their on-going DIAN-TU tau study (NCT01760005). Listed in Eisai pipeline update, dated Jan 31, 2020, as Phase 1. NCT04231513 Phase 1, A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Intravenous Infusions of E2814 in Healthy Subjects, started in Dec 2019 active not recruiting as of last update in Feb 2023. The clinical candidate was discovered as part of the research collaboration between Eisai and University College London. |
| Full address of company | 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan Asia Japan https://www.eisai.com/company/profile/group/index.html#anc-01 |
E2814 is a humanised, high affinity, IgG1 antibody recognising the tau microtubule binding region (MTBR). E2814 is being developed as a disease modifying agent for Alzheimer’s disease and other tauopathies, Phase I clinical studies are under preparation. E2814 is designed to prevent the spreading of tau seeds within the brains of affected individuals. DOI: 10.1186/s40478-020-0884-2; https://pubmed.ncbi.nlm.nih.gov/32019610/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |