sovleplenib (HMPL-523)

P1, N=18, Recruiting, Hutchmed

P1, N=54, Recruiting, Hutchmed

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).

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

P1, N=0, Withdrawn, Hutchmed | N=48 --> 0 | Recruiting --> Withdrawn

P3, N=272, Active, not recruiting, Hutchison Medipharma Limited | Trial primary completion date: Oct 2024 --> Mar 2025

P1, N=134, Completed, Hutchison Medipharma Limited | Unknown status --> Completed | N=217 --> 134

P2/3, N=110, Recruiting, Hutchison Medipharma Limited | Active, not recruiting --> Recruiting

P1, N=45, Completed, Hutchison Medipharma Limited | Unknown status --> Completed

P1, N=6, Completed, Hutchmed | Active, not recruiting --> Completed | N=10 --> 6

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

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.