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更新于：2026-01-05
Sovleplenib
索乐匹尼布
更新于：2026-01-05
概要
基本信息
药物类型 小分子化药 |
别名 醋酸索乐匹尼布、HM-0523、HMPL 523 + [2] |
靶点 |
作用方式 抑制剂 |
作用机制 Syk抑制剂(脾酪氨酸激酶抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构 |
权益机构- |
最高研发阶段临床2/3期 |
首次获批日期- |
最高研发阶段(中国)临床2/3期 |
特殊审评优先审评 (中国)、突破性疗法 (中国) |
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结构/序列
分子式C24H30N6O3S |
InChIKeyNJIAKNWTIVDSDA-FQEVSTJZSA-N |
CAS号1415792-84-5 |
关联
16
项与 索乐匹尼布 相关的临床试验CTR20254670
一项在健康参与者中评价食物对HMPL-523乙酸盐片药代动力学影响的开放、随机、三周期、六序列的I期研究
CTR20253792
评价两种不同制剂处方的HMPL-523乙酸盐片在中国健康参与者体内药代动力学和生物等效性的单中心、开放、随机、交叉的I期临床研究
NCT06291415
A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia
100 项与 索乐匹尼布 相关的临床结果
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100 项与 索乐匹尼布 相关的转化医学
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100 项与 索乐匹尼布 相关的专利（医药）
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14
项与 索乐匹尼布 相关的文献（医药）2025-12-05Hematology-American Society of Hematology Education Program
Management of autoimmune hemolytic anemia
Review
作者: Fattizzo, Bruno ; Barcellini, Wilma
Abstract:
Autoimmune hemolytic anemia (AIHA) is caused by premature erythrocyte destruction mediated by autoantibodies (auto-Ab) with or without complement activation. The most frequent form (60%-70% of cases) is warm AIHA (wAIHA), driven by immunoglobulin G auto-Ab that react at body temperature. Cold agglutinin disease (CAD, 20%-25%) is the second most common form and is caused by immunoglobulin M auto-Ab that usually react at temperatures <20°C and strongly activate complement. Rarer forms (5%-10%) include mixed AIHAs (wAIHA plus CAD), and paroxysmal cold hemoglobinuria. Here, we present the management of wAIHA, as CAD is discussed separately. Approximately 50% of wAIHA are primary, whereas the remainder are secondary to various conditions (infections, lymphoproliferative disorders, systemic or organ-specific autoimmune diseases, congenital immunodeficiencies, hematopoietic stem-cell transplantation, and several drugs, including immune checkpoint inhibitors). The disease is highly heterogeneous, ranging from fully compensated to life-threatening, and frequently has a relapsing course. Standard first-line therapy includes steroids with or without intravenous immunoglobulin, transfusions when anemia is clinically significant, prophylactic anticoagulation for severe hemolysis, and recombinant erythropoietin when reticulocytopenia/inadequate bone marrow compensation is present. For severe cases, high-dose steroids and plasma-exchange may be considered. 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).
2025-02-01Lancet Haematology
Expanding treatment options for warm autoimmune haemolytic anaemia
Article
作者: Berentsen, Sigbjørn
A review.The treatment landscape for warm autoimmune haemolytic anemia (wAIHA) has gradually shifted from reliance on clin. experience to evidence-based strategies.In a significant contribution to this progress, Zhao et al.Conducted a randomized, placebo-controlled, double-blind phase 2 trial evaluating sovleplenib, an oral selective spleen tyrosine kinase (SYK) inhibitor, in adults with relapsed or refractory wAIHA.Among 21 patients, 67% achieved a Hb response by week 24, with a durable response in 48%.Compared to placebo, sovleplenib reduced transfusion needs and rescue therapy usage, and improved fatigue scores.The drug exhibited a distinct and manageable safety profile.These findings highlight sovleplenib as a promising third-line treatment option, particularly in light of limited efficacy and tolerability seen with other SYK inhibitors like fostamatinib.Further validation in larger phase 3 trials is warranted.Emerging therapies, including FcRn inhibitors, also hold potential, underscoring the evolving complexity of individualized wAIHA treatment.
2025-02-01Lancet Haematology
Sovleplenib in patients with primary or secondary warm autoimmune haemolytic anaemia: results from phase 2 of a randomised, double-blind, placebo-controlled, phase 2/3 study
Article
作者: Zhou, Hu ; Li, Fei ; Luo, Xian ; Li, Yingmei ; Zhao, Xin ; Zhang, Zhihua ; Chen, Miao ; Li, Xin ; Han, Bing ; Yin, Hongyan ; Guo, Xiaojun ; Liu, Hong ; Su, Weiguo ; Wang, Xiaoqin ; He, Guangsheng ; Fan, Songhua ; Sun, Jing ; Zhang, Liansheng ; Zhang, Fengkui ; Hong, Mei ; Shi, Michael M ; Lei, Lei ; Li, Yang ; Gong, Tiejun
BACKGROUND:
Spleen tyrosine kinase inhibitors are potential treatment options for warm autoimmune haemolytic anaemia. This study aimed to assess the preliminary efficacy and safety of sovleplenib-an oral spleen tyrosine kinase inhibitor-in patients with warm autoimmune haemolytic anaemia in China. Here we report on the phase 2 results.
METHODS:
This randomised, double-blind, placebo-controlled, phase 2 part from the phase 2/3 study was conducted at 13 centres in China. Eligible patients, aged 18-75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of no more than 2, had primary or secondary warm autoimmune haemolytic anaemia (stable underlying disease not requiring drug intervention) with no response to previous glucocorticoid treatment, haemoglobin of less than 100 g/L with active haemolysis, and a positive direct antiglobulin test. The study comprised two periods; patients were randomly assigned (3:1) to receive sovleplenib or placebo at 300 mg orally once a day in the 8-week double-blind period. Upon completion, all patients entered an open-label treatment period for at least 16 weeks and received sovleplenib 300 mg once a day until 24 weeks after the last patient was randomly assigned. The primary endpoint for phase 2 of the trial was overall haemoglobin response rate (haemoglobin ≥100 g/L with an increase of ≥20 g/L from baseline at least once, and haemoglobin not affected by rescue therapy, such as red blood cell transfusions, intravenous immunoglobulin, and glucocorticoids) by week 24. Efficacy analyses in the 0-8 week double-blind period included all patients who were randomly assigned, analysed by intention-to-treat. Safety analysis in the double-blind period included patients in the intention-to-treat population who received at least one dose of the study medication. This phase 2/3 study is registered with ClinicalTrials.gov, NCT05535933, and the phase 3 part is ongoing.
FINDINGS:
Between Sept 26, 2022, and May 9, 2023, 34 patients were screened and 21 patients (four [19%] male and 17 [81%] female) were enrolled in the study and randomly assigned to receive either sovleplenib (n=16) or placebo (n=5). All 21 patients completed the 0-8-week double-blind treatment and entered the open-label treatment period. The overall haemoglobin response rate was 67% (14 of 21 patients) by week 24, and durable haemoglobin response rate was 48% (ten of 21 patients) by week 24. During the 0-8-week double-blind treatment, 13 (81%) of 16 patients in the sovleplenib group versus five (100%) of five patients taking placebo reported treatment-emergent adverse events (TEAEs), and four (25%) of 16 patients versus four (80%) of five patients reported grade 3 adverse events. Although all 21 patients had a TEAE during the 24-week treatment with sovleplenib, only seven (33%) patients had grade 3 events. The most common grade 3 TEAE was anaemia (four [19%] patients), which was not related to treatment. There were no grade 4 or 5 TEAEs.
INTERPRETATION:
Sovleplenib treatment achieved an encouraging overall haemoglobin response in Chinese patients with warm autoimmune haemolytic anaemia and was well tolerated. The phase 3 part of the study (ESLIM-02) is currently ongoing to further substantiate the efficacy and safety of sovleplenib in this setting.
FUNDING:
HUTCHMED.
100 项与 索乐匹尼布 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 免疫性血小板减少症 | 申请上市 | 中国 | 2024-01-11 | |
| 免疫性血小板减少症 | 申请上市 | 中国 | 2024-01-11 | |
| 自身免疫性溶血性贫血 | 临床3期 | 中国 | 2022-09-30 | |
| 温热型自身免疫性溶血性贫血 | 临床3期 | 中国 | 2022-09-30 | |
| 出血 | 临床1期 | 美国 | 2024-04-02 | |
| 出血 | 临床1期 | 澳大利亚 | 2024-04-02 | |
| 出血 | 临床1期 | 德国 | 2024-04-02 | |
| 出血 | 临床1期 | 挪威 | 2024-04-02 | |
| 出血 | 临床1期 | 西班牙 | 2024-04-02 | |
| 皮肤表现 | 临床1期 | 美国 | 2024-04-02 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 21 | 襯襯廠夢網範醖鏇鏇範(範糧範窪膚顧鹽願窪鏇) = During the 0-8-week double-blind treatment, 13 (81%) of 16 patients in the sovleplenib group versus five (100%) of five patients taking placebo reported treatment-emergent adverse events (TEAEs) 齋觸窪觸範廠築鹽餘鹽 (構糧膚鑰鏇鹽顧鑰繭鑰 ) 更多 | 积极 | 2025-02-01 | |||
Placebo | |||||||
临床3期 | 188 | 齋觸醖襯醖積鹹壓廠廠(憲鬱簾衊網選範齋壓遞) = 製選夢憲遞鑰鑰繭願廠 觸鏇糧淵膚淵壓憲蓋鏇 (鹹壓簾鹹繭顧顧範衊糧 ) 更多 | 积极 | 2024-06-13 | |||
Placebo | 齋觸醖襯醖積鹹壓廠廠(憲鬱簾衊網選範齋壓遞) = 糧蓋艱鹽襯顧鑰鹽襯鬱 觸鏇糧淵膚淵壓憲蓋鏇 (鹹壓簾鹹繭顧顧範衊糧 ) 更多 | ||||||
临床3期 | 188 | Sovleplenib 300 mg once daily | 艱製積願醖餘願艱觸觸(網壓簾壓廠積鑰構築顧) = 鬱獵鑰艱艱夢窪糧憲鬱 網遞廠鏇顧製膚獵鑰鑰 (築餘製淵觸鬱遞製蓋壓 ) 更多 | 积极 | 2024-05-14 | ||
Placebo | 憲積鬱鑰鏇顧廠艱製鑰(衊觸衊鹹廠窪憲遞願窪) = 壓範築淵顧衊憲廠遞醖 積餘艱築積簾鑰憲衊餘 (襯築憲襯遞範鬱獵構淵 ) | ||||||
临床3期 | 188 | 餘夢壓窪醖憲壓窪鹽獵(鑰餘願範觸齋網製構夢) = 鏇選艱簾糧餘糧糧選餘 獵餘鹹鹹鏇積醖憲繭淵 (構糧壓餘構積齋鑰衊顧 ) 更多 | 积极 | 2024-05-14 | |||
Placebo | 簾顧鹽鏇醖鹹鹹夢艱襯(鹽淵襯糧積蓋膚範積網) = 繭築網鑰構廠蓋觸製糧 構構艱憲遞網壓構艱構 (鏇鹹夢製網鏇齋窪範蓋 ) | ||||||
临床2期 | 25 | 鏇鬱膚構艱繭鹽醖襯憲(餘簾網範夢遞淵獵鹹遞) = 構鹽艱製糧網遞鹹製獵 夢鹽願膚鑰窪範壓衊衊 (餘鬱網淵夢鬱簾艱淵積 ) 更多 | 积极 | 2024-05-14 | |||
临床3期 | 188 | 顧鹽鏇遞築齋積壓鑰鹹(繭觸積網蓋鹽構鏇壓鹹) = 鑰襯艱鏇築繭簾壓觸鹽 淵構鑰窪蓋蓋網觸構顧 (製構遞蓋餘鹽構顧選衊 ) 更多 | 积极 | 2024-05-14 | |||
Placebo | 顧鹽鏇遞築齋積壓鑰鹹(繭觸積網蓋鹽構鏇壓鹹) = 夢窪顧構膚齋餘範觸餘 淵構鑰窪蓋蓋網觸構顧 (製構遞蓋餘鹽構顧選衊 ) 更多 | ||||||
临床2期 | 21 | 鑰製鏇範襯襯鏇鬱鹹夢(淵鹽鹽淵製繭選鬱憲構) = 積願淵艱遞鏇鑰顧憲醖 鑰夢齋廠壓選遞遞艱糧 (憲憲衊願選築淵艱選鏇 ) 更多 | 积极 | 2024-05-14 | |||
Placebo | 鑰製鏇範襯襯鏇鬱鹹夢(淵鹽鹽淵製繭選鬱憲構) = 鏇艱醖憲醖積廠襯夢製 鑰夢齋廠壓選遞遞艱糧 (憲憲衊願選築淵艱選鏇 ) 更多 | ||||||
临床1期 | 47 | 鏇衊積構齋齋窪繭壓齋(糧艱蓋膚選遞憲衊繭構) = 獵鑰構夢艱醖膚淵簾觸 獵遞網範鹹選淵餘繭顧 (窪鹹糧構製製醖襯醖鹹 ) 更多 | 积极 | 2024-04-05 | |||
临床3期 | 188 | 鬱膚艱構餘願窪膚窪淵(憲簾膚積蓋選顧醖齋簾) = 该试验成功达到了其主要终点，即与接受安慰剂治疗的患者相比，接受索乐匹尼布治疗的患者的持续应答率取得了具有临床意义和统计学意义的显著改善。 衊築鹽廠構衊餘鹽繭鹹 (鏇簾鏇築觸窪觸獵壓築 ) 达到 更多 | 积极 | 2023-08-21 | |||
安慰剂 | |||||||
临床1/2期 | 45 | 壓鑰齋顧鹹獵繭鹹簾糧(獵簾願艱醖顧獵壓繭餘) = two grade 2 or worse treatment-related treatment-emergent adverse events occurred in the sovleplenib groups 鏇齋廠窪構築襯艱鬱鬱 (蓋壓糧鹹憲壓構網鹽顧 ) 更多 | 积极 | 2023-04-04 | |||
Placebo |
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