Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1273 |
| INN | Drotokibart |
| Status | Clinical |
| Drug code(s) | SHR-1819 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | TBD |
| Format, general category | TBD |
| Format details | TBD |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-4R alpha |
| Indications of clinical studies | Atopic Dermatitis, Asthma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 20, 2020 |
| Start of Phase 2 | September 15, 2023 |
| Start of Phase 3 | September 19, 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 | Shanghai Hengrui Pharmaceutical Co. Ltd. |
| Licensee/Partner | Atridia Pty Ltd. |
| Comments about company or candidate | NCT06554509 Phase 2/3 in Prurigo Nodularis started in Sep 2024. NCT06468956 Phase 3 in atopic dermatitis due to start in June 2024. NCT06012812 Phase 2 in Atopic Dermatitis enrolling by invitation starting in Sep 2023. Not listed in Hengrui pipeline dated Sep 2022. As of Feb 2023, two Phase 1 studies are completed and two studies are not yet recruiting NCT05549947 / CTR20222411 Phase 2 in atopic dermatitis due to start in Oct 2022. NCT05549947 Phase 1 due to start in Jan 2022. NCT04561128 is a Phase 1 in healthy subjects; NCT04772365 is a Phase 1 in asthma complete as of Nov 2022. |
| Full address of company | Jiangsu, China Asia China https://www.hengrui.com/en/index.html |
SHR-1819 targets IL-4R https://www.hengrui.com/en/pipeline.html immunoglobulin G4-kappa, anti-[Homo sapiens IL4R (interleukin 4 receptor, IL4RA, IL-4RA, interleukin 13 receptor, CD124)], humanized monoclonal antibody;
| Anticipated events | Phase 3 pending |
| Factor(s) contributing to discontinuation | None |