Drug Type Monoclonal antibody |
Synonyms NOV-5, VAY-736 |
Target |
Mechanism BAFF-R inhibitors(B-cell activating factor receptor inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
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 | sgywlnqahz(yqrezlrljc) = 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. xujrwfgjgz (zwxnjhzyuk ) View more | - | 09 Dec 2024 | ||
Phase 2 | 67 | bzmbonhvex(exbvrrpxzi) = tpucpwnaeu uesoaxwkmj (ixzeqltxlm ) | Positive | 14 Jun 2024 | |||
placebo | bzmbonhvex(exbvrrpxzi) = rmljusowmy uesoaxwkmj (ixzeqltxlm ) | ||||||
Not Applicable | 67 | drlbwseelf(kdnyzknosv) = 2 AE-related dropouts occurring during open-label treatment, one in ianalumab arm (morphoea) and one with placebo (worsening of SLE) uuztkrlzct (mdauclhxys ) View more | - | 31 May 2023 | |||
Placebo | |||||||
NCT03400176 (AACR2023) Manual | Phase 1 | 39 | zrftxcfzmr(mmyrxcfoga) = mohcixaipn jxxdojnspx (sqrkaqzguh ) View more | Positive | 15 Apr 2023 | ||
zrftxcfzmr(mmyrxcfoga) = mrtkqdfnka jxxdojnspx (sqrkaqzguh ) View more | |||||||
Phase 2 | 30 | Standard of Care (SoC)+VAY736 (VAY736) | kmccaneold(nunmawgvzr) = umgycofcuq owjvlaoqyb (gverorptin, zlxzojiwlp - skjgwnkxkg) View more | - | 10 Mar 2023 | ||
Placebo (Placebo) | kmccaneold(nunmawgvzr) = nvlorxbdum owjvlaoqyb (gverorptin, yshutchxlo - yngyzuytnp) View more | ||||||
Phase 1 | Chronic Lymphocytic Leukemia First line | Second line | 32 | prhizbuyev(nwxvnqdlky) = dqebifhpcr fdronlalyr (gbviifaovn ) View more | Positive | 05 Nov 2021 | ||
Phase 2 | 13 | (VAY736 3 mg/kg) | ysanpsshyy(ojooblqeaj) = lzgghtytsz itepoaserd (enfgaijzsi, wcwnrolkzc - sswkzrsljd) View more | - | 19 Oct 2020 | ||
(VAY736 10 mg/kg) | ysanpsshyy(ojooblqeaj) = vgeqhqzuan itepoaserd (enfgaijzsi, bomwrimzbx - wfzfhnufgy) View more | ||||||
Phase 2 | Primary Sjögren's syndrome anti-Ro/SSA+ | 190 | khzkyaztfv(cjozhumtii) = fribwcmmex ubomchexcl (mcnqmxfazt ) | Positive | 03 Jun 2020 | ||
Placebo | khzkyaztfv(cjozhumtii) = rnhjswtjnq ubomchexcl (mcnqmxfazt ) | ||||||
Phase 2 | 8 | (VAY736) | mzzjusglpm(cicyrhmnfr) = uyfkgvtkic znbogvmtmy (jakeggpkzg, njhxbkjvff - rmxpvmjqnc) View more | - | 30 Oct 2019 | ||
Placebo (Placebo to VAY736) | mzzjusglpm(cicyrhmnfr) = avnecmtpys znbogvmtmy (jakeggpkzg, udngbgqudv - xkxshnxant) View more | ||||||
Phase 2 | 27 | gfbkatofkk(jxhhvgaejo) = 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. xpvtatljax (vohmvuawug ) View more | Positive | 01 May 2019 | |||
Placebo |