Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 683 |
| INN | Depemokimab |
| Status | Clinical |
| Drug code(s) | GSK3511294 |
| 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) | IL-5 |
| Indications of clinical studies | Hypereosinophilic Syndrome, Nasal Polyps, Eosinophilic Granulomatosis With Polyangiitis, Mild to Moderate Asthma |
| 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) | October 17, 2017 |
| Start of Phase 2 | |
| Start of Phase 3 | January 26, 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 | GSK |
| Licensee/Partner | None |
| Comments about company or candidate | Phase 3 studies for Hypereosinophilic syndrome (NCT05334368); Eosinophilic granulomatosis with polyangiitis (NCT05263934); are recruiting as of September 2024. Phase 3 studies in Nasal polyps (NCT05274750, NCT05281523) have been completed; Phase 3 studies in severe uncontrolled asthma with an eosinophilic phenotype (NCT05243680 and NCT04718389) are active non recruiting as of Spetember-October 2024, while NCT04719832 and NCT04718103 studies have been completed. May 2024: Positive results from SWIFT 1 and 2 announced https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-phase-iii-severe-asthma-trials-of-depemokimab/ Phase 3 studies for Hypereosinophilic syndrome (NCT05334368); Eosinophilic granulomatosis with polyangiitis (NCT05263934); Nasal polyps (NCT05274750, NCT05281523); Severe uncontrolled asthma with an eosinophilic phenotype (NCT05243680, NCT04719832, NCT04718103, NCT04718389) are all recruiting as of Jan-May 2023 except NCT04719832 and NCT04718103 for asthma which are active not recruiting as of Feb-May 2023. Two Phase 3 studies in nasal polyps started in Mar 2022. Three Phase 3 studies started in Jan 2021 (NCT04718389, NCT04718103, NCT04719832). Listed as Phase 1 in GSK pipeline accessed Aug 12, 2019. FIH Phase 1 NCT03287310 study still recruiting as of Aug 2018. GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5 which is known to block binding of IL-5 to the IL-5 receptor complex, causing a reduction in the circulating population of eosinophils. |
| Full address of company | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/ |
GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5
| Anticipated events | BLA possible in asthma and Chronic rhinosinusitis with nasal polyps in H2 2024 (https://www.gsk.com/media/11102/q1-2024-pipeline-assets-and-clinical-trials-report.pdf) |
| Factor(s) contributing to discontinuation | None |