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    DRUG:

    ianalumab (VAY736)

    i
    Other names: VAY736, NOV-5, VAY-736, VAY 736, NOV5, NOV 5
    Associations

    News

    Trials
    Company:
    Novartis
    Drug class:
    BAFF-R inhibitor
    Related drugs:
    Associations

    News

    Trials
    3d
    AMBER: ADCC Mediated B-Cell dEpletion and BAFF-R Blockade (clinicaltrials.gov)
    P2/3, N=68, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    ianalumab (VAY736)
    3d
    VAY2EXPLORE: A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) (clinicaltrials.gov)
    P2, N=164, Not yet recruiting, Novartis Pharmaceuticals
    New P2 trial
    |
    Promacta (eltrombopag) • Nplate (romiplostim) • ianalumab (VAY736)
    14d
    VAYHIA: A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia (clinicaltrials.gov)
    P3, N=90, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: May 2029 --> Dec 2028
    Trial completion date
    |
    ianalumab (VAY736)
    20d
    Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments. (clinicaltrials.gov)
    P2, N=21, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Jan 2026
    Trial completion • Trial completion date
    |
    ianalumab (VAY736)
    25d
    Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) (clinicaltrials.gov)
    P3, N=285, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • IFNAR2 (Interferon Alpha And Beta Receptor Subunit 2)
    |
    ianalumab (VAY736)
    25d
    Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) (clinicaltrials.gov)
    P3, N=434, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • IFNAR2 (Interferon Alpha And Beta Receptor Subunit 2)
    |
    ianalumab (VAY736)
    27d
    VAY RE-HIT: Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab (clinicaltrials.gov)
    P2, N=60, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ianalumab (VAY736)
    2ms
    VAYHIA: A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia (clinicaltrials.gov)
    P3, N=90, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ianalumab (VAY736)
    2ms
    A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov)
    P2, N=200, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Jul 2028 --> Jul 2027
    Trial primary completion date
    |
    ianalumab (VAY736)
    2ms
    VAY RE-HIT: Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Novartis Pharmaceuticals | Initiation date: Oct 2025 --> Jan 2026
    Trial initiation date
    |
    ianalumab (VAY736)
    3ms
    Management of autoimmune hemolytic anemia. (PubMed, Hematology Am Soc Hematol Educ Program)
    Rituximab is now the preferred second-line option for relapsed/refractory patients, comparing favorably with the traditional splenectomy. The latter is increasingly reserved for later lines together with classic immunosuppressants. Several novel treatments are in development for refractory wAIHA, encompassing drugs targeting B-cells (parsaclisib, ibrutinib, rilzabrutinib, zanubrutinib, obexelimab, ianalumab, povetacicept), plasma cells (bortezomib, daratumumab), spleen tyrosine kinase (fostamatinib, sovleplenib), and the neonatal Fc receptor (nipocalimab).
    Review • Journal
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    SYK (Spleen tyrosine kinase)
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • bortezomib • Brukinsa (zanubrutinib) • Darzalex (daratumumab) • parsaclisib (INCB50465) • Tavalisse (fostamatinib) • ianalumab (VAY736) • sovleplenib (HMPL-523)
    3ms
    Managed Access Programs for VAY736, Ianalumab (clinicaltrials.gov)
    P=N/A, N=0, Temporarily Not Available, Novartis Pharmaceuticals
    New trial
    |
    ianalumab (VAY736)