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更新于：2026-02-04
Parsaclisib
帕萨利司
更新于：2026-02-04
概要
基本信息
原研机构 |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、突破性疗法 (中国)、优先审评 (美国)、优先审评 (中国) |
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结构/序列
分子式C20H22ClFN6O2 |
InChIKeyZQPDJCIXJHUERQ-QWRGUYRKSA-N |
CAS号1426698-88-5 |
关联
32
项与 帕萨利司 相关的临床试验NCT07149818
A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia
NCT05867030
A Phase Ib/III Study to Evaluating the Efficacy and Safety of Parsaclisib in Combination With Rituximab and Lenalidomide Versus Rituximab in Combination With Lenalidomide in Subjects With Relapsed or Refractory Follicular Lymphoma
NCT04796922
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma
100 项与 帕萨利司 相关的临床结果
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100 项与 帕萨利司 相关的转化医学
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100 项与 帕萨利司 相关的专利（医药）
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43
项与 帕萨利司 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).
2025-08-01CANCER SCIENCE
Article
作者: Ogawa, Yoshiaki ; Suzukawa, Kazumi ; Ito, Toshiro ; Katagiri, Seiichiro ; Kuroda, Junya ; Uchida, Toshiki ; Ishiguro, Takuro ; Kinami, Kenzo ; Fukuhara, Noriko ; Yamamoto, Ryusuke ; Fujimoto, Katsuya ; Nakazato, Tomonori ; Hiramatsu, Yasushi ; Yoshida, Isao ; Zhou, Mi ; Negoro, Eiju
ABSTRACT:
Follicular lymphoma (FL) is the second most common subtype of non‐Hodgkin lymphoma (NHL) in Japan, the United States, and Western Europe. Parsaclisib is a potent, selective next‐generation PI3Kδ inhibitor that has demonstrated clinical efficacy and tolerability in phase II studies of patients with relapsed or refractory (R/R) B‐cell NHL, including FL. We report results from CITADEL‐213 (NCT04434937), a phase II study evaluating the efficacy and safety of parsaclisib in Japanese patients with R/R FL. Eligible patients were aged ≥ 18 years with histologically confirmed R/R FL (grade 1, 2, or 3a), had received two or more prior systemic therapies, and were ineligible for hematopoietic stem cell transplantation. Patients received parsaclisib 20 mg once daily for 8 weeks, followed by parsaclisib 2.5 mg once daily thereafter. The primary endpoint was the objective response rate (ORR). At the data cut‐off (February 16, 2023), 42 patients had received treatment with parsaclisib, of whom 41 were evaluable for change in target tumor size. Median (range) age at baseline was 66.5 (52–87) years. ORR (95% confidence interval [CI]) was 88.1% (74.4–96.0), with 10 patients (23.8%) experiencing a complete response and 27 patients (64.3%) experiencing a partial response. Median (95% CI) duration of response was not reached (8.0 months−not estimable). The most common treatment‐emergent adverse events (TEAEs) were diarrhea (28.6%; grade ≥ 3, 7.1%) and stomatitis (23.8%; grade ≥ 3, 11.9%); TEAEs led to parsaclisib discontinuation in five patients (11.9%). There were no fatal TEAEs. In conclusion, parsaclisib monotherapy demonstrated durable responses with a manageable safety profile in Japanese patients with R/R FL.Trial Registration:ClinicalTrials.gov, NCT04434937
2024-12-01AMERICAN JOURNAL OF HEMATOLOGY
Parsaclisib for the treatment of primary autoimmune hemolytic anemia: Results from a phase 2, open‐label study
Article
作者: Wahid T. Hanna ; Ke Szeto ; Lance Leopold ; Louis Terriou ; Fabrizio Pane ; Shaoceng Wei ; Wilma Barcellini ; Maria T. DeSancho ; Ulrich Jäger ; Andrea Patriarca ; Irina Murakhovskaya ; Erica Rappold
Abstract:
Autoimmune hemolytic anemia (AIHA) is a group of acquired autoimmune disorders characterized by red blood cell hemolysis. In a phase 2, open‐label, multicenter study, adults with warm AIHA, cold agglutinin disease, or mixed‐type AIHA were administered once‐daily 1.0 or 2.5 mg parsaclisib (selective phosphoinositide 3‐kinase δ inhibitor) orally for 12 weeks, followed by an extension period. Dose increases (for AIHA worsening) or decreases (for tolerability) were permitted. Primary efficacy endpoint was the proportion of patients with complete (≥12 g/dL hemoglobin [Hgb]) or partial (10–12 g/dL Hgb or ≥2 g/dL increase from baseline) response at any visit during weeks 6–12 not attributable to transfusion. Among 25 enrolled patients (median age, 63 y), 16 (64%) achieved a partial or complete Hgb response during weeks 6–12. Responses were observed by week 1 in 52.0% of patients with incremental improvements during weeks 6–12 and sustained responses during the extension period. Responses were higher among patients with warm AIHA versus other types (75.0% vs. 44.4%). Clinically meaningful improvements in Functional Assessment of Chronic Illness Therapy‐Fatigue scores were observed at weeks 6 and 12. All patients had treatment‐emergent adverse events (TEAEs), most commonly diarrhea (32.0%) and pyrexia (28.0%). Grade ≥3 TEAEs occurred in 13 patients (52.0%). TEAEs considered possibly related to treatment occurred in 11 patients (44.0%). No dose reductions were required; six patients (24%) discontinued for a TEAE. In summary, parsaclisib was well tolerated and resulted in substantial improvements in Hgb response at week 1, with durable responses through the extension period.
Clinical trial registration:
This trial was registered at ClinicalTrials.gov (NCT03538041).
100 项与 帕萨利司 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 |
|---|---|---|---|---|
| 复发性滤泡性淋巴瘤 | 申请上市 | 中国 | 2023-01-06 | |
| 复发性滤泡性淋巴瘤 | 申请上市 | 中国 | 2023-01-06 | |
| 复发性滤泡性淋巴瘤 | 申请上市 | 中国 | 2023-01-06 | |
| 难治性滤泡性淋巴瘤 | 申请上市 | 中国 | 2023-01-06 | |
| 难治性滤泡性淋巴瘤 | 申请上市 | 中国 | 2023-01-06 | |
| 难治性滤泡性淋巴瘤 | 申请上市 | 中国 | 2023-01-06 | |
| 滤泡性淋巴瘤 | 申请上市 | 美国 | 2021-11-01 | |
| 套细胞淋巴瘤 | 申请上市 | 美国 | 2021-11-01 | |
| 边缘区B细胞淋巴瘤 | 申请上市 | 美国 | 2021-11-01 | |
| 温热型自身免疫性溶血性贫血 | 临床3期 | 美国 | 2022-03-15 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 54 | (Cohort 1: R/R DLBCL) | 齋製獵膚鏇繭鏇夢膚糧 = 襯製蓋觸膚遞糧蓋築鬱 構積蓋壓獵網衊廠網鑰 (鏇襯鹹淵鹹蓋願憲夢鑰, 蓋齋選鹹顧顧艱膚窪築 ~ 膚顧壓築鹽壓網積鬱鹽) 更多 | - | 2026-01-29 | ||
(Cohort 2: R/R MCL) | 齋製獵膚鏇繭鏇夢膚糧 = 壓築廠夢憲選餘窪膚壓 構積蓋壓獵網衊廠網鑰 (鏇襯鹹淵鹹蓋願憲夢鑰, 蓋範遞築繭鬱鏇蓋蓋鬱 ~ 醖齋齋廠淵衊憲鬱鬱遞) 更多 | ||||||
临床3期 | 13 | (Parsaclisib) | 襯壓壓廠製壓鑰鏇憲襯 = 夢繭構艱鬱觸鏇夢願蓋 繭餘築餘觸襯製鑰願築 (夢鏇鹽鹽膚鹽築遞鏇糧, 鬱夢鏇齋顧鑰網積觸窪 ~ 鏇範窪鹽窪範齋範製選) 更多 | - | 2025-01-15 | ||
placebo (Placebo) | 襯壓壓廠製壓鑰鏇憲襯 = 襯鹽顧淵獵願遞願願糧 繭餘築餘觸襯製鑰願築 (夢鏇鹽鹽膚鹽築遞鏇糧, 範製鹽願夢鹹壓獵淵壓 ~ 壓獵網淵鏇獵築網觸網) 更多 | ||||||
N/A | - | Parsaclisib plus R-CHOP | 積築鑰鹽願獵遞遞淵壓(齋膚壓鹹遞膚鑰艱膚糧) = 71.4% vs 16.3% 壓簾範觸獵糧蓋窪廠衊 (鏇觸遞積壓餘範鹹遞鑰 ) 更多 | - | 2024-12-08 | ||
Parsaclisib plus Pola-R-CHP | |||||||
临床2期 | 25 | Parsaclisib 1.0 mg | 鑰鹹簾齋膚餘夢鑰憲淵(憲鑰選積願窪顧鑰衊襯) = 壓構願壓憲構廠觸鑰窪 遞廠襯夢繭夢憲糧選積 (憲觸齋鏇簾窪鑰鏇願襯 ) 更多 | 积极 | 2024-12-01 | ||
临床3期 | 252 | Parsaclisib+Ruxolitinib (Parsaclisib Plus Ruxolitinib) | 願憲獵繭窪蓋糧窪鹽顧 = 築簾糧憲憲鬱範簾衊齋 選襯觸醖鬱衊醖蓋網繭 (蓋淵獵廠選淵網餘壓鏇, 網構繭夢壓願積艱鬱積 ~ 鏇範鹹衊蓋糧夢繭糧艱) 更多 | - | 2024-10-04 | ||
Placebo+Ruxolitinib (Placebo Plus Ruxolitinib) | 願憲獵繭窪蓋糧窪鹽顧 = 齋構鏇製鏇餘餘鏇鹽觸 選襯觸醖鬱衊醖蓋網繭 (蓋淵獵廠選淵網餘壓鏇, 鏇顧願餘襯築糧構顧鹹 ~ 網餘衊網糧齋夢選築製) 更多 | ||||||
临床3期 | 177 | (Parsaclisib Plus Ruxolitinib) | 鏇壓簾築鬱構衊壓製網 = 鏇願鬱膚製廠襯膚範廠 淵蓋簾壓獵遞構鬱廠鏇 (衊壓觸醖醖鬱艱範蓋襯, 鬱齋鑰淵窪選觸範繭遞 ~ 觸簾鑰鏇憲壓夢選夢顧) 更多 | - | 2024-08-23 | ||
Placebo+Ruxolitinib (Placebo Plus Ruxolitinib) | 鏇壓簾築鬱構衊壓製網 = 鏇鑰窪淵齋醖壓糧糧憲 淵蓋簾壓獵遞構鬱廠鏇 (衊壓觸醖醖鬱艱範蓋襯, 襯選鬱遞餘蓋夢鏇窪艱 ~ 壓鬱膚衊淵蓋蓋膚繭願) 更多 | ||||||
临床2期 | 骨髓纤维化 追加 | 74 | 蓋製餘膚夢顧鹽願蓋築(襯糧衊觸糧鹹範遞範積) = 夢夢憲襯鹹遞鬱艱鹽夢 廠淵膚鑰鹽構淵鑰鹽夢 (範艱齋鬱壓膚廠網範襯 ) | 积极 | 2024-03-26 | ||
蓋製餘膚夢顧鹽願蓋築(襯糧衊觸糧鹹範遞範積) = 築網壓積鏇網醖觸壓壓 廠淵膚鑰鹽構淵鑰鹽夢 (範艱齋鬱壓膚廠網範襯 ) | |||||||
临床2期 | 42 | 鑰築窪淵鏇夢衊顧膚觸 = 構願鬱鬱遞鹽鹽糧淵艱 顧窪糧鏇窪糧範鹽願醖 (夢膚淵鹽糧壓廠簾餘夢, 憲糧餘艱廠構醖鏇選願 ~ 醖齋蓋鹽衊餘鹽鬱繭鹽) 更多 | - | 2024-01-03 | |||
临床1期 | 159 | 願窪餘壓餘醖膚顧築餘(築衊觸鏇構鏇壓遞選憲) = Most common itacitinib treatment-related adverse events (TRAE) were fatigue, nausea, and anemia. 鹽艱淵鏇範齋願齋艱醖 (積艱鹽壓衊構範鑰夢餘 ) 更多 | 不佳 | 2023-12-19 | |||
临床2期 | 61 | 積餘餘膚網製齋壓廠鏇(壓築窪積齋憲願獵餘襯) = 齋鑰襯襯衊憲積夢窪簾 選壓膚範淵膚壓糧蓋膚 (選憲襯願範鬱獵夢範艱, 82.7 ~ 97.6) 更多 | - | 2023-06-08 |
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