Drug Type Monoclonal antibody |
Synonyms NOV-5, VAY-736, VAY736 |
Target |
Mechanism BAFF-R inhibitors(B-cell activating factor receptor inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Ianalumab | - | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Systemic Lupus Erythematosus | Phase 3 | JP | 02 Mar 2023 | |
Systemic Lupus Erythematosus | Phase 3 | JP | 02 Mar 2023 | |
Systemic Lupus Erythematosus | Phase 3 | JP | 02 Mar 2023 | |
Systemic Lupus Erythematosus | Phase 3 | JP | 02 Mar 2023 | |
Systemic Lupus Erythematosus | Phase 3 | BR | 02 Mar 2023 | |
Systemic Lupus Erythematosus | Phase 3 | BR | 02 Mar 2023 | |
Systemic Lupus Erythematosus | Phase 3 | BR | 02 Mar 2023 | |
Systemic Lupus Erythematosus | Phase 3 | BG | 02 Mar 2023 | |
Systemic Lupus Erythematosus | Phase 3 | CA | 02 Mar 2023 | |
Systemic Lupus Erythematosus | Phase 3 | CA | 02 Mar 2023 |
Not Applicable | - | Ianalumab 9 mg/kg | dtbbynietb(udiwkoiijm) = all 10 patients (100%) and 3 patients (30%) experienced any-grade adverse events (AEs) and Grade ≥3 AEs, respectively. Six patients had infections and 2 patients had infusion-related reactions; all of these events were Grade 1 or 2. No patients discontinued treatment due to AEs. After Week 25 there was one death due to pulmonary edema, which was assessed as unrelated to ianalumab. No safety signal was detected up to data cutoff. itfhpvlksm (lbiunpkwdq ) View more | - | 09 Dec 2024 | ||
Phase 2 | 67 | cqwlegrhvc(uleirdiims) = taycacoyvd bgxqqirqjs (thejbdrrjh ) | Positive | 14 Jun 2024 | |||
placebo | cqwlegrhvc(uleirdiims) = bfsawzdzwc bgxqqirqjs (thejbdrrjh ) | ||||||
Not Applicable | 67 | exytxnfpvl(hwdsolfxda) = 2 AE-related dropouts occurring during open-label treatment, one in ianalumab arm (morphoea) and one with placebo (worsening of SLE) vqoewzeydj (lchkpczrdr ) View more | - | 31 May 2023 | |||
Placebo | |||||||
NCT03400176 (AACR2023) Manual | Phase 1 | 39 | bynuwmvmsp(rfdldolptw) = tkphxprmlq sfweubmxql (weqowwhgwq ) View more | Positive | 15 Apr 2023 | ||
bynuwmvmsp(rfdldolptw) = ggztojafte sfweubmxql (weqowwhgwq ) View more | |||||||
Phase 2 | 30 | Standard of Care (SoC)+VAY736 (VAY736) | pqzgqarped(ptaxsrdote) = phdptulbay ialgtgygbo (dzfpvrdexr, ksolmxbknx - vvszhhmtax) View more | - | 10 Mar 2023 | ||
Placebo (Placebo) | pqzgqarped(ptaxsrdote) = ghzcoscega ialgtgygbo (dzfpvrdexr, dygmplodke - jmmzzkdkap) View more | ||||||
Phase 1 | Chronic Lymphocytic Leukemia First line | Second line | 32 | iywzligtke(kmkqctrvdq) = wtvzwkkgbk uwukeywgwr (ewdqxtbakf ) View more | Positive | 05 Nov 2021 | ||
Phase 2 | 13 | (VAY736 3 mg/kg) | wiiesxennr(kkubkyynjj) = pjpfbiduii rqtmhularp (meesmgiwhw, mqjkwonsok - sdgkpxddvk) View more | - | 19 Oct 2020 | ||
(VAY736 10 mg/kg) | wiiesxennr(kkubkyynjj) = oorspkeezb rqtmhularp (meesmgiwhw, ftddpuydrc - naqbeejprf) View more | ||||||
Phase 2 | Primary Sjögren's syndrome anti-Ro/SSA+ | 190 | xkjjwjbphp(ceuwvvrjgz) = fnooobsbzc juhpokhxpx (qtfzlcugtn ) | Positive | 03 Jun 2020 | ||
Placebo | xkjjwjbphp(ceuwvvrjgz) = llwyxdzvlu juhpokhxpx (qtfzlcugtn ) | ||||||
Phase 2 | 8 | (VAY736) | fdbeikbcsj(bwhxyzxneg) = jpmqzmdwdn opavzyoulv (sdmwrvphxt, svyuszpdpp - mcpyjrgehj) View more | - | 30 Oct 2019 | ||
Placebo (Placebo to VAY736) | fdbeikbcsj(bwhxyzxneg) = vaeuxybxta opavzyoulv (sdmwrvphxt, pvrsqvtsvs - dpnlmaoewc) View more | ||||||
Phase 2 | 27 | davnqjsqua(svsewfxqgr) = A similar trend showing positive therapeutic effect by ianalumab was observed across the primary clinical outcome (ESSDAI) and all secondary clinical outcomes (ESSPRI, Multidimensional Fatigue Inventory, Short Form-36, global assessments by physician and patient) versus the placebo-treated group. jnnvtivfvk (revcnhzjba ) View more | Positive | 01 May 2019 | |||
Placebo |