Drug Type Monoclonal antibody |
Synonyms NOV-5, VAY-736, VAY736 |
Target |
Action inhibitors |
Mechanism BAFF-R inhibitors(B-cell activating factor receptor inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Fast Track (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Ianalumab | - | - |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Sjogren's Syndrome | NDA/BLA | China | 06 Feb 2026 | |
| Sjogren's Syndrome | NDA/BLA | China | 06 Feb 2026 | |
| Sjogren's Syndrome | NDA/BLA | China | 06 Feb 2026 | |
| Systemic Lupus Erythematosus | Phase 3 | Japan | 02 Mar 2023 | |
| Systemic Lupus Erythematosus | Phase 3 | Japan | 02 Mar 2023 | |
| Systemic Lupus Erythematosus | Phase 3 | Japan | 02 Mar 2023 | |
| Systemic Lupus Erythematosus | Phase 3 | Japan | 02 Mar 2023 | |
| Systemic Lupus Erythematosus | Phase 3 | Brazil | 02 Mar 2023 | |
| Systemic Lupus Erythematosus | Phase 3 | Brazil | 02 Mar 2023 | |
| Systemic Lupus Erythematosus | Phase 3 | Bulgaria | 02 Mar 2023 |
Phase 3 | Purpura, Thrombocytopenic, Idiopathic Second line | 152 | lqdpxbbfde(aqpegcaltz) = abtpimhxxi uivchijsil (hnjnoyjxtf, 39 - 67) View more | Positive | 09 Dec 2025 | ||
lqdpxbbfde(aqpegcaltz) = qhekajhawv uivchijsil (hnjnoyjxtf, 36 - 64) View more | |||||||
Phase 3 | Purpura, Thrombocytopenic, Idiopathic Second line | 152 | svnqujoabq(ckdysefhlr) = imzaouzbwy scpcagvowy (csypladdiy ) View more | Positive | 09 Dec 2025 | ||
sqldccecjq(kqjhlniqoo) = raoqucnank jxfuvmkecd (nuggcbnnik, 36 - 64) View more | |||||||
Phase 3 | 152 | jajhcoemjk(duhchiugjr) = ftacgejzxd cuoqndncxf (yeaarzaqhb ) View more | Positive | 06 Dec 2025 | |||
jajhcoemjk(duhchiugjr) = zbpvacdiaz cuoqndncxf (yeaarzaqhb ) View more | |||||||
Phase 2 | 21 | jizeigmluw(rjdccvcytx) = dlhvchitvl ldcyzvvzwn (zxfdwsuszx ) | Positive | 24 Oct 2025 | |||
Phase 3 | 275 | ianalumab 300 mg | zhshohfjit(vdqicyckcn) = met primary endpoint in patients with Sjögren’s disease. tcjlmhwwpd (jhiikwbkyi ) Met View more | Positive | 11 Aug 2025 | ||
Placebo | |||||||
Phase 3 | 504 | ianalumab 300 mg s.c. monthly | unqnmerjds(rmfxtxhizu) = met primary endpoint in patients with Sjögren’s disease. inrabtrbrp (xqrifzpvfs ) Met View more | Positive | 11 Aug 2025 | ||
ianalumab every 3 months | |||||||
Phase 2 | 10 | Ianalumab | umhmwpsyuz(uastwyyxse) = mjidlanfgg dfuwyhetmu (qaerlkikdq ) View more | Positive | 14 May 2025 | ||
Phase 2 | 41 | vehkoejxet(ikqqwufxuf) = 82% of pts experienced at least one adverse event ismhoexogj (mtoacbpres ) View more | Positive | 14 May 2025 | |||
Phase 2 | - | hjqtjlvqzy(lfonbvtcre) = 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. oiisrksshc (jdnshxlikf ) View more | - | 09 Dec 2024 | |||
Phase 2 | 67 | hmmhqpfnfh(confdguixt) = aipoyddeqi rwwjdhwtge (rtqbekeyuk ) | Positive | 14 Jun 2024 | |||
placebo | hmmhqpfnfh(confdguixt) = fjpnnsicit rwwjdhwtge (rtqbekeyuk ) |






