Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1101 |
| INN | Dazukibart |
| Status | Clinical |
| Drug code(s) | PF-06823859, PF06823859 |
| 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) | IFN beta |
| Indications of clinical studies | Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)], Lupus, Dermatomyositis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 27, 2016 |
| Start of Phase 2 | January 23, 2018 |
| Start of Phase 3 | May 20, 2023 |
| 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 | Pfizer |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06698796 Phase 3 in Idiopathic Inflammatory Myopathies ORPHAN -U.S., E.U., PRIME -E.U.; FAST TRACK – U.S (https://cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_29OCT2024.pdf?VersionId=E70MbubUKVzMZ8UF6fmYfS3KDJLP3pmH) NCT05895786 Phase 3 study in Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM) started in May 2023. NCT05879718 Phase 2 in lupus due to start in June 2023. NCT03181893 Phase 2 study started in Jan 2018 still recruiting patients as of last update in Feb 20121. |
| Full address of company | 66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact |
Immunoglobulin G1 [236-alanine,237-alanine,239-alanine,de-C-terminal-lysine], anti- (human interferon β) (human-Mus musculus monoclonal PF-06823859 γ1-chain), disulfide with human-Mus musculus monoclonal PF-06823859 κ-chain, dimer
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |