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    DRUG:

    sovleplenib (HMPL-523)

    i
    Other names: HMPL-523, HMPL 523, HMPL523
    Associations

    News

    Trials
    Company:
    Hutchmed
    Drug class:
    SYK inhibitor
    Related drugs:
    Associations

    News

    Trials
    22d
    Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets (clinicaltrials.gov)
    P1, N=18, Completed, Hutchmed | Recruiting --> Completed
    Trial completion
    |
    sovleplenib (HMPL-523)
    22d
    Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans (clinicaltrials.gov)
    P1, N=54, Completed, Hutchmed | Recruiting --> Completed | Trial primary completion date: Feb 2026 --> Nov 2025
    Trial completion • Trial primary completion date
    |
    sovleplenib (HMPL-523)
    2ms
    Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets (clinicaltrials.gov)
    P1, N=18, Recruiting, Hutchmed
    New P1 trial
    |
    sovleplenib (HMPL-523)
    2ms
    Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans (clinicaltrials.gov)
    P1, N=54, Recruiting, Hutchmed
    New P1 trial
    |
    sovleplenib (HMPL-523)
    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
    |
    SYK (Spleen tyrosine kinase)
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • bortezomib • Brukinsa (zanubrutinib) • Darzalex (daratumumab) • parsaclisib (INCB50465) • Tavalisse (fostamatinib) • ianalumab (VAY736) • sovleplenib (HMPL-523)
    6ms
    2018-523-00US1: An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma (clinicaltrials.gov)
    P1, N=87, Terminated, Hutchmed | N=140 --> 87 | Trial completion date: Jan 2026 --> Mar 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Mar 2025; Study terminated by sponsor
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    sovleplenib (HMPL-523)
    6ms
    The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP) (clinicaltrials.gov)
    P1, N=0, Withdrawn, Hutchmed | N=48 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    sovleplenib (HMPL-523)
    12ms
    ESLIM-01: Phase III Study on HMPL-523 for Treatment of ITP (clinicaltrials.gov)
    P3, N=272, Active, not recruiting, Hutchison Medipharma Limited | Trial primary completion date: Oct 2024 --> Mar 2025
    Trial primary completion date
    |
    sovleplenib (HMPL-523)
    over1year
    A Study of Hutchison MediPharma Limited(HMPL)-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms (clinicaltrials.gov)
    P1, N=134, Completed, Hutchison Medipharma Limited | Unknown status --> Completed | N=217 --> 134
    Trial completion • Enrollment change
    |
    sovleplenib (HMPL-523)
    over1year
    wAIHA: HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (clinicaltrials.gov)
    P2/3, N=110, Recruiting, Hutchison Medipharma Limited | Active, not recruiting --> Recruiting
    Enrollment open
    |
    sovleplenib (HMPL-523)
    over1year
    The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients (clinicaltrials.gov)
    P1, N=45, Completed, Hutchison Medipharma Limited | Unknown status --> Completed
    Trial completion
    |
    sovleplenib (HMPL-523)
    over1year
    Human Mass Balance of [14C]HMPL-523 in Healthy Adult Male Chinese Subjects (clinicaltrials.gov)
    P1, N=6, Completed, Hutchmed | Active, not recruiting --> Completed | N=10 --> 6
    Trial completion • Enrollment change
    |
    sovleplenib (HMPL-523)