Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 32 |
| INN | Divozilimab |
| Status | Approved |
| Drug code(s) | BCD-132 |
| Brand name | Ivlizi |
| 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) | CD20 |
| Indications of clinical studies | Neuromyelitis Optica Spectrum Disorders, Systemic Scleroderma, Multiple sclerosis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved Russia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | February 22, 2018 |
| Start of Phase 2 | June 07, 2019 |
| Start of Phase 3 | April 05, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2023 |
| Date of first US approval | |
| INN, US product name | Divozilimab |
| US or EU approved indications | None |
| Company | Biocad |
| Licensee/Partner | None |
| Comments about company or candidate | In March 2023 Biocad announced "The Ministry of Health of the Russian Federation has authorizedthe first Russian originator for the treatment of multiple sclerosis developed by the scientists of the biotechnology company BIOCAD. The medicinal product was given the trade name Ivlizi® (INN: divozilimab). Approved in Russia on Mar 24, 2023 for Relapsing Remitting Multiple Sclerosis (RRMS),Secondary Progressive Multiple Sclerosis. NCT05726630 Phase 3 in Systemic Scleroderma started in Dec 2022. Aug 2022: No 2022 updates on company webpage. NCT05385744 Phase 3 study in MS started in April 2021 has a primary completion date in March 2023. NCT04056897 Phase 2 active not recruiting in May 2021. Listed in Biocad pipeline as Phase 3. |
| Full address of company | 198515, Saint Petersburg, Intracity Municipality the Settlement of Strelna, ul. Svyazi, d. 38, str. 1, pomeshch. 89 Europe Russia https://biocadglobal.com/contacts |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |