Drugs / Ianalumab
Trials 34 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06411639 | Nov 2024 → Dec 2025 | Sjogren syndrome, systemic lupus erythematosus | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 1 | NCT04903197 | Jan 2022 → Feb 2025 | diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT03574545 | Dec 2018 → Jul 2024 | rheumatoid arthritis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03400176 | Apr 2018 → Sep 2023 | B-cell chronic lymphocytic leukemia | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02137889 | Jul → Nov 2012 | B-cell chronic lymphocytic leukemia | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02675803 | Dec 2010 → Jan 2018 | rheumatoid arthritis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02495129 | Dec 2015 → Sep 2017 | Sjogren syndrome | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT07660172 | Feb 2027 → Apr 2033 expected | autoimmune thrombocytopenia | Novartis Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07421167 | Jun 2026 → Apr 2028 expected | Evans syndrome | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT07039422 | Jun 2026 → Aug 2030 expected | autoimmune hemolytic anemia, warm type, primary thrombocytopenia | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06470048 | Oct 2024 → Jul 2027 expected | diffuse cutaneous systemic sclerosis | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06293365 | Jul 2024 → Feb 2026 overdue | Sjogren syndrome, rheumatoid arthritis, systemic lupus erythematosus | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05885555 | Aug 2023 → Feb 2025 overdue | primary thrombocytopenia | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05124925 | Jul 2022 → Jun 2024 | Sjogren syndrome | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03827798 | Feb 2019 → Dec 2024 overdue | hidradenitis suppurativa | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03656562 | Dec 2018 → Jul 2022 | systemic lupus erythematosus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03287414 | Dec 2017 → Nov 2020 | idiopathic pulmonary fibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02962895 | Jun 2017 → Jun 2020 | Sjogren syndrome | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02149420 | May 2014 → Feb 2018 | Sjogren syndrome | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02038049 | Dec 2013 → May 2015 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01930175 | Dec 2013 → Sep 2019 | pemphigus vulgaris | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03217422 | Feb 2018 → Dec 2023 | autoimmune hepatitis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT07621809 | Jul 2026 → Aug 2029 expected | Sjogren syndrome | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06711887 | May 2025 → Aug 2035 expected | lupus nephritis | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06133972 | May 2024 → Apr 2030 expected | systemic lupus erythematosus | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05985915 | Oct 2023 → Apr 2033 expected | Sjogren syndrome | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05624749 | Apr 2023 → Apr 2027 expected | systemic lupus erythematosus | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05639114 | Mar 2023 → Mar 2027 expected | systemic lupus erythematosus | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05653349 | Feb 2023 → Oct 2026 expected | primary thrombocytopenia | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05653219 | Feb 2023 → Jun 2025 overdue | primary thrombocytopenia | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05648968 | Dec 2022 → Feb 2026 overdue | autoimmune hemolytic anemia, warm type | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05349214 | Aug 2022 → May 2025 overdue | Sjogren syndrome | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05350072 | Jul 2022 → May 2025 | Sjogren syndrome | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05126277 | Jul 2022 → Jun 2027 expected | lupus nephritis | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT07244289 Background | — | Sjogren syndrome, primary thrombocytopenia | Novartis Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-01-16 | Novartis Pharmaceuticals | Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease novartis.com ↗ |
| 2025-12-09 | Novartis Pharmaceuticals | Novartis ianalumab significantly extends disease control in patients with immune thrombocytopenia with only four once-monthly doses novartis.com ↗ |
| 2025-10-29 | Novartis Pharmaceuticals | Novartis ianalumab first drug to reduce disease activity and patient burden in Sjögren’s disease Phase III trials novartis.com ↗ |
| 2025-08-12 | Novartis Pharmaceuticals | Novartis ianalumab Phase III trial meets primary endpoint in ITP, demonstrating statistically significant improvement in time to treatment failure novartis.com ↗ |
| 2025-08-11 | Novartis Pharmaceuticals | Novartis announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren’s disease novartis.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ianalumab | “The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL...” NCT06293365 ↗21“Three-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome.” NCT05349214 ↗ “Two-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome.” NCT05350072 ↗ “Ianalumab” NCT02962895 ↗ |
| Known as | NVP-VAY736 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594357 ↗ |
| Known as | VAY736 | “Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).” NCT06711887 ↗17“Three-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome.” NCT05349214 ↗ “Two-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome.” NCT05350072 ↗ “Ianalumab VAY736 150mg/1ml Solution for injection” NCT05124925 ↗ |
| Modality | Monoclonal antibody | “VAY736 is a human immunoglobulin of the G class (IgG1/k) monoclonal antibody (mAb) designed to specifically bind the BAFF receptor.” NCT02137889 ↗ |
| Route | Intravenous | “single dose iv of VAY736 at a dose of 3mg/kg” NCT01930175 ↗ |
| Target | TNFRSF13C | “Tumor necrosis factor receptor superfamily member 13C binding agent” CHEMBL4594357 ↗ |