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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
    6d
    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)
    3ms
    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)
    3ms
    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    P1, N=0, Withdrawn, Hutchmed | N=48 --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 Withdrawn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)
    9ms
    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)
    over1year
    ESLIM-01: Phase III Study on HMPL-523 for Treatment of ITP (clinicaltrials.gov)
    P3, N=272, Active, not recruiting, Hutchison Medipharma Limited | N=188 --> 272 | Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Oct 2024
    Enrollment change • Trial completion date • Trial primary completion date
    |
    sovleplenib (HMPL-523)
    over1year
    Efficacy and safety of sovleplenib (HMPL-523) in adult patients with chronic primary immune thrombocytopenia in China (ESLIM-01): a randomised, double-blind, placebo-controlled, phase 3 study. (PubMed, Lancet Haematol)
    Sovleplenib showed a clinically meaningful sustained platelet response in patients with chronic primary immune thrombocytopenia, with a tolerable safety profile and improvement in quality of life. Sovleplenib could be a potential treatment option for patients with immune thrombocytopenia who received one or more previous therapy.
    P3 data • Journal
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    SYK (Spleen tyrosine kinase)
    |
    sovleplenib (HMPL-523)
    over1year
    Discovery of Sovleplenib, a Selective Inhibitor of Syk in Clinical Development for Autoimmune Diseases and Cancers. (PubMed, ACS Med Chem Lett)
    Sovleplenib is a potent and selective Syk inhibitor with favorable preclinical PK profiles and robust anti-inflammation efficacy in a preclinical collagen-induced arthritis model. Sovleplenib is now being developed for treating autoimmune diseases such as immune thrombocytopenic purpura and warm antibody hemolytic anemia as well as hematological malignancies.
    Journal
    |
    SYK (Spleen tyrosine kinase)
    |
    sovleplenib (HMPL-523)
    over1year
    The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP) (clinicaltrials.gov)
    P1, N=48, Recruiting, Hutchmed | Not yet recruiting --> Recruiting
    Enrollment open
    |
    sovleplenib (HMPL-523)