Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1415 |
| INN | Ianalumab |
| Status | Clinical |
| Drug code(s) | VAY736, NOV-5 |
| Brand name | None |
| mAb sequence source | mAb human |
| 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 | Phage display (HuCAL)-derived antibody |
| Target(s) | BAFFR |
| Indications of clinical studies | Diffuse Cutaneous Systemic Sclerosis, Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Systemic Lupus Erythematosus, Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Autoimmune Hepatitis, Systemic Lupus Erythematosus, Pulmonary fibrosis, rheumatoid arthritis, Primary Sjögren's syndrome, Pemphigus Vulgaris, Relapse Remitting Multiple Sclerosis, Leukemia |
| 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 15, 2012 |
| Start of Phase 2 | December 15, 2013 |
| Start of Phase 3 | February 28, 2018 |
| 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 | Novartis Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | Q2 2024 update: Possible submission in 2026 (https://www.novartis.com/sites/novartis_com/files/q2-2024-investor-presentation.pdf) Q2 2023 update: 1L and 2L ITP readouts in 2025 with submission in 2026 Phase 3 studies for Sjogren syndrome (NCT05350072 is recruiting as of March 2023, NCT05349214 is recruiting as of May 2023); Lupus nephritis (NCT05126277); Systemic Lupus Erythematosus (NCT05624749, NCT05639114) are recruiting as of April 2023; Warm Autoimmune Hemolytic Anemia (wAIHA) (NCT05648968) is recruiting as of May 2023; Primary Immune Thrombocytopenia (ITP) (NCT05653349, NCT05653219) are recruiting as of May 2023; and phase 2/3 study for Autoimmune hepatitis (NCT03217422) is recruiting as of September 21, 2022. Fast track for Sjogren Syndrome NCT05648968 Phase 3 in Warm Autoimmune Hemolytic Anemia started in Dec 2022. NCT05350072 and NCT05349214 Phase 3 studies in Sjogren Syndrome started in Aug 2022; NCT05126277 Phase 3 in Lupus Nephritis started in July 2022. Phase 2/3 in Autoimmune Hepatitis still recruiting as of May 2021. Results from NCT02962895 Phase 2B study in Primary sjogren's syndrome expected in H2-2020. NCT03656562 Phase 2 study in lupus started recruiting in Dec 2018. Total of 6 Phase 1/2 or 2 studies listed on clinicaltrials.gov as of Aug 2017. Phase 2/3 NCT03217422 AMBER study in Autoimmune Hepatitis started in Feb 2018. |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts |
immunoglobulin G1-kappa, anti-[Homo sapiens TNFRSF13C (tumor necrosis factor receptor (TNFR) superfamily member 13C, BAFFR, BAFF-R, BR3, B cell activating factor receptor, CD268)], Homo sapiens monoclonal antibody
| Anticipated events | Submission readout in 2025, possible submission in 2026 |
| Factor(s) contributing to discontinuation | None |