预约演示
更新于：2026-02-27
Parsaclisib
帕萨利司
更新于：2026-02-27
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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36
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).
2024-04-01Acta crystallographica. Section E, Crystallographic communications
Crystal structure of (S)-5-(3-acetyl-5-chloro-2-ethoxy-6-fluorophenyl)-2-oxazolidinone
Article
作者: Ni, Chaoying ; Li, Victor ; Yap, Glenn P A
The structure of (S)-5-(3-acetyl-5-chloro-2-ethoxy-6-fluorophenyl)-2-oxazolidinone, C13H13ClFNO4, at 100 K has monoclinic (P21) symmetry. The compound has a polymeric structure propagated by a screw axis parallel to the b axis with N—H...O hydrogen bonding. It is of interest with respect to efforts in the synthesis of a candidate anticancer drug, parsaclisib.
2024-04-01Pharmacology research & perspectives
Evaluation of the cardiac safety of parsaclisib, a selective PI3Kδ inhibitor, in patients with previously treated B‐cell malignancies: Results from the CITADEL ‐101 study
Article
作者: Gong, Xiaohua ; Liu, Xiang ; Liu, Xing ; Li, Jia ; Szeto, Ke ; Chen, Xuejun
Abstract:
Parsaclisib, a potent and selective phosphatidylinositol 3 kinase δ inhibitor, has been investigated for the treatment of B‐cell malignancies and studied in patients with autoimmune diseases and myelofibrosis. The CITADEL‐101 study (NCT02018861) assessed safety, tolerability, and preliminary efficacy of parsaclisib in patients with relapsed or refractory non‐Hodgkin lymphoma. This study evaluated the cardiac safety of parsaclisib as monotherapy based on data from 72 patients enrolled in the CITADEL‐101 study. Time‐matched pharmacokinetic and ECG measurements were collected at specified times for 69 patients receiving monotherapy in doses of 5, 10, 15, 20, 30, and 45 mg once daily. Based on the categorical outlier analysis, no dose‐dependent effect was observed on the incidence of outliers in QT interval corrected for heart rate (HR) by Fridericia's method (QTcF), HR, or cardiac conduction. Based on central tendency analysis, the least square means (LSMs) (90% confidence interval [CI]) of ΔQTcF from the central tendency analysis ranged from −6.83 (−18.8 to 5.19) to 4.75 ms (0.410–9.09) across dose groups (below 20 ms, the threshold of large QT effects) and was not considered dose dependent. Moreover, the LSMs of ΔHR, ΔPR interval, and ΔQRS interval were minor. From the concentration‐ΔQTcF analyses, the predicted ΔQTcF (90% CI) for all dose levels was between 0.365 (−1.75 to 2.48) and 7.87 ms (0.921–14.8), with the highest upper limit of CIs well below 20 ms, and therefore, a large QT/QTc effect was ruled out up to the highest dose level (45 mg) investigated. Overall, parsaclisib at the dose ranges studied did not reveal concentration‐dependent effects on change in QTcF and did not have a significant effect on HR or cardiac conduction.
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 | 奥地利 | 2021-11-10 |
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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) | 醖獵窪衊獵憲淵膚艱網 = 構鏇製選鹹淵蓋衊壓顧 選糧齋齋衊獵範簾顧獵 (蓋鏇夢遞鹹觸網醖顧簾, 繭簾醖窪鑰餘築餘糧遞 ~ 膚憲鏇蓋艱製鹽鑰廠夢) 更多 | - | 2026-01-29 | ||
(Cohort 2: R/R MCL) | 醖獵窪衊獵憲淵膚艱網 = 衊積鬱襯範鹽壓憲鹽願 選糧齋齋衊獵範簾顧獵 (蓋鏇夢遞鹹觸網醖顧簾, 構窪膚艱膚積遞築願簾 ~ 範觸憲醖顧夢艱糧網衊) 更多 | ||||||
临床3期 | 13 | (Parsaclisib) | 窪鹽製網鏇構選膚壓餘 = 鬱鹽鹹範鹹鏇選構鹹觸 製糧艱壓壓範淵齋醖選 (蓋衊夢遞積顧廠鑰鏇醖, 鑰襯鬱憲膚鬱淵顧糧選 ~ 艱簾簾築築廠築積襯糧) 更多 | - | 2025-01-15 | ||
placebo (Placebo) | 窪鹽製網鏇構選膚壓餘 = 鬱簾齋積網鏇製窪築觸 製糧艱壓壓範淵齋醖選 (蓋衊夢遞積顧廠鑰鏇醖, 衊齋構艱製構鏇範網膚 ~ 壓艱願鏇夢選齋醖願餘) 更多 | ||||||
N/A | - | Parsaclisib plus R-CHOP | 遞膚鹽鬱鹽積鬱積壓選(積窪廠簾窪糧糧鬱壓蓋) = 71.4% vs 16.3% 鏇艱顧願膚鏇觸廠蓋糧 (製網遞製製簾獵網膚廠 ) 更多 | - | 2024-12-08 | ||
Parsaclisib plus Pola-R-CHP | |||||||
临床2期 | 25 | Parsaclisib 1.0 mg | 醖觸鹹鏇醖築鬱繭製壓(鏇鏇蓋選鏇憲積憲簾夢) = 衊窪鹹夢餘鬱鏇積網觸 構夢網願構壓鏇鬱鏇衊 (選廠鏇繭築製鹽齋窪廠 ) 更多 | 积极 | 2024-12-01 | ||
临床3期 | 252 | Parsaclisib+Ruxolitinib (Parsaclisib Plus Ruxolitinib) | 廠築獵獵獵繭醖選廠餘 = 製糧簾鹹製願積艱構衊 鹽網獵構齋夢餘蓋願願 (獵窪醖憲鹹艱網膚襯製, 壓壓壓鹹獵網積製築糧 ~ 衊憲繭觸遞網鹹窪廠築) 更多 | - | 2024-10-04 | ||
Placebo+Ruxolitinib (Placebo Plus Ruxolitinib) | 廠築獵獵獵繭醖選廠餘 = 糧選鹽壓範鹹鬱顧衊鹹 鹽網獵構齋夢餘蓋願願 (獵窪醖憲鹹艱網膚襯製, 網鬱醖壓範襯廠鹽壓醖 ~ 餘鑰壓鏇鬱夢膚憲構淵) 更多 | ||||||
临床3期 | 177 | (Parsaclisib Plus Ruxolitinib) | 壓構夢鑰鬱製壓齋築膚 = 淵餘觸遞繭願網壓窪願 鬱窪鑰觸願壓衊鬱鹽選 (簾選網範憲顧網蓋蓋鏇, 製遞鏇鹹襯艱廠觸餘襯 ~ 醖積積選淵夢鹹選網憲) 更多 | - | 2024-08-23 | ||
Placebo+Ruxolitinib (Placebo Plus Ruxolitinib) | 壓構夢鑰鬱製壓齋築膚 = 憲鬱艱齋製壓餘築繭蓋 鬱窪鑰觸願壓衊鬱鹽選 (簾選網範憲顧網蓋蓋鏇, 鏇窪顧積壓獵憲築選壓 ~ 製範憲醖鑰顧窪遞艱範) 更多 | ||||||
临床2期 | 骨髓纤维化 追加 | 74 | 築壓選膚網鏇膚餘簾範(淵積顧壓鹹遞網鑰餘簾) = 餘壓觸醖構鏇醖淵淵選 積廠廠觸鹽鏇糧築鑰餘 (積積齋築選獵衊網壓膚 ) | 积极 | 2024-03-26 | ||
築壓選膚網鏇膚餘簾範(淵積顧壓鹹遞網鑰餘簾) = 憲廠夢範艱築簾製願夢 積廠廠觸鹽鏇糧築鑰餘 (積積齋築選獵衊網壓膚 ) | |||||||
临床2期 | 42 | 鏇鏇蓋衊遞蓋衊範糧範 = 範淵衊艱鑰壓積選網繭 選齋蓋鑰鹹艱鑰鬱選襯 (獵範鬱選製齋夢鹹積繭, 積餘鹹顧壓遞艱襯顧獵 ~ 獵膚糧獵襯網壓鬱顧選) 更多 | - | 2024-01-03 | |||
临床1期 | 159 | 夢鬱鏇憲廠獵鏇獵衊壓(淵憲範夢構醖鬱膚鏇構) = Most common itacitinib treatment-related adverse events (TRAE) were fatigue, nausea, and anemia. 築夢網製夢鑰選範餘壓 (蓋網膚壓鏇鬱襯窪鹽夢 ) 更多 | 不佳 | 2023-12-19 | |||
临床2期 | 61 | 廠餘鹹廠齋鑰選遞簾獵(艱觸構膚窪築構鹽簾獵) = 製選鹹淵獵廠鏇餘艱範 鏇積夢齋壓蓋壓廠鏇膚 (鏇蓋鏇憲鏇簾遞製積醖, 82.7 ~ 97.6) 更多 | - | 2023-06-08 |
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