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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
    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    P1, N=0, Withdrawn, Hutchmed | N=48 --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 Withdrawn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
    |
    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)
    almost2years
    The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP) (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Hutchmed
    New P1 trial
    |
    sovleplenib (HMPL-523)