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更新于：2026-01-29
Selexipag
司来帕格
更新于：2026-01-29
概要
基本信息
药物类型 小分子化药 |
别名 Selexipag (JAN/USAN/INN)、赛乐西帕、ACT-293987 + [7] |
作用方式 激动剂 |
作用机制 PGI2 receptor激动剂(前列腺素IP受体激动剂) |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2015-12-21), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (韩国)、临床急需境外新药 (中国)、优先审评 (中国) |
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结构/序列
分子式C26H32N4O4S |
InChIKeyQXWZQTURMXZVHJ-UHFFFAOYSA-N |
CAS号475086-01-2 |
关联
50
项与 司来帕格 相关的临床试验NCT07356375
PROMISE: Evaluation of Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension
CTR20252498
评估受试制剂司来帕格片（规格：0.4 mg）与参比制剂Uptravi®（规格：0.4 mg）在健康成年参与者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验
NCT06932198
Randomized, Single Oral Dose, Two-period, Two-treatment, Two-sequence Open-label, Crossover, Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag), in Healthy Subjects Under Fed Conditions
100 项与 司来帕格 相关的临床结果
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100 项与 司来帕格 相关的转化医学
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100 项与 司来帕格 相关的专利（医药）
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314
项与 司来帕格 相关的文献（医药）2026-03-01PULMONARY PHARMACOLOGY & THERAPEUTICS
Setting expectations with oral selexipag: an expert consensus-based approach on best practices to initiate, dose, titrate, and manage side effects (SEs) in patients with pulmonary arterial hypertension (PAH)
Article
作者: Benninger, Christina K ; Oswald, Charlotte W ; Doad, Gurinderpal S ; Mayeux, Jennalyn D ; Mazurek, Jeremy A ; Stone, Medi A ; McConnell, J Wesley ; Wu, Sheryl E ; Strachan, Paul M ; Val-Maranes, Luis ; Cho, Michelle C ; Habib, Naomi G ; Perry, Richard M ; Bridge, Daisy
BACKGROUND:
Oral selexipag, a prostacyclin receptor agonist, has been shown to delay pulmonary arterial hypertension (PAH) progression and reduce the risk of hospitalization for PAH. To ensure optimal patient outcomes with selexipag, careful treatment titration and expected side effect (SE) management are required. This study aimed to obtain expert consensus on the appropriate management of patients with PAH treated with selexipag.
METHODS:
United States (US) healthcare professionals (N = 17, 11 physicians; 5 nurse practitioners; 1 registered nurse) participated in this modified-Delphi panel comprising two online surveys and a consensus meeting. Consensus was defined as ≥80% panelists agreeing using a 9-point Likert scale.
RESULTS:
Panelists prescribed selexipag according to FDA label recommendations to patients with PAH. Panelists acknowledged considerations prompting adjustment in titration speed, agreeing that individual maximum dose is based on SE tolerability. It was agreed that the duration of SEs is variable and patient-specific, however, SEs often become manageable over time. Panelists identified methods for managing SEs, agreeing this should be proactive. Panelists highlighted the importance of communicating with patients to set expectations, to enhance engagement and adherence. Panelists agreed that treatment initiation, titration, and SE management should be individualized to suit each patient, with decision-making primarily based on patient characteristics and treatment preference.
DISCUSSION:
This panel provided expert opinions on the clinical use of and best practices for treatment titration and management of expected SEs for oral selexipag. Insights are valuable for developing standardized clinical guidelines and best practices, as well as ensuring personalized treatment to improve patient care.
2026-01-01Pulmonary Circulation
Global Resource Disparities Between Pulmonary Hypertension Centers: Results From the International Survey by the PVRI IDDI Access to Care Workstream
Article
作者: Rischard, Franz ; Golden, Gil ; Raj, J. Usha ; Prisco, Sasha Z. ; Bernardo, Roberto ; Balasubramanian, Vijay ; Kantorovich, Alexander ; Liu, Yan ; Sahay, Sandeep
ABSTRACT:
There is a limited understanding of how pulmonary hypertension (PH) patients are managed worldwide. The Pulmonary Vascular Research Institute (PVRI) Innovative Drug Discovery Initiative (IDDI) global survey attempted to obtain insights into access to PH care in diverse international regions to pave future action plans. Responses from 151 centers (19.9% from Europe, 3.9% Middle East, 6% South Asia, 17.9% East Asia, 2% Sub‐Saharan Africa, 31.8% Latin America, and 18.5% North America) were received. Most respondents had access to electrocardiography, echocardiography, and right heart catheterization but less availability to pulmonary function tests, ventilation/perfusion scans, and genetic testing. Phosphodiesterase type 5 (PDE‐5) inhibitors were available in almost all centers but there was limited access to oral, inhaled, and parenteral prostacyclin therapy, riociguat, and selexipag. Cluster analysis of middle‐high‐ and high income countries demonstrated significant variability in PH care delivery and disparities in therapeutic resources across the three clusters. The most common limitations identified that contribute to delayed PH diagnosis were insufficient financial resources, insufficient staff, and limited time. Survey respondents requested access to webinars with content experts (45%), access to content experts for consultation and review of complex cases via video chat (55%), resources to attend a conference (67.5%), and provision of a mentorship program (33.1%) along with greater availability of medications, remote conference access, clinical trial availability, and increased advocacy for patients. Survey results suggest significant disparities across the globe. Further research is needed to understand access to PH care and therapies in non‐expert/academic centers and regional disparities within countries.
2025-12-01CHEST
A Prospective, Multicenter, Open-Label, Single-Arm Phase 2 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Exploratory Efficacy of Selexipag in Children With Pulmonary Arterial Hypertension
Article
作者: Hsu Schmitz, Shu-Fang ; Russu, Alberto ; Beghetti, Maurice ; Leng, Sining ; Lesage, Catherine ; Grill, Simon ; Remeňová, Tatiana ; Borissoff, Julian I ; Axelsen, Lene Nygaard ; Farhan, Mahdi ; Moledina, Shahin
BACKGROUND:
Selexipag is an oral selective prostacyclin receptor agonist approved for treating pulmonary arterial hypertension (PAH) in adults.
RESEARCH QUESTION:
What is the starting dose(s) of selexipag needed in patients aged ≥2-<18 years with PAH to achieve exposure comparable to adults (primary objective)?
STUDY DESIGN AND METHODS:
In this prospective, multicenter, open-label, single-arm, Phase 2 study (NCT03492177), patients were categorized by age (≥2-<6; ≥6-<12; ≥12-<18 years) and weight (≥9-<25; ≥25-<50; ≥50-kg). Selexipag starting doses (μg b.i.d.) were based on patient bodyweight (≥50-kg, 200; ≥25-<50-kg, 150; and ≥9-<25-kg, 100) and titrated to the individual maximum tolerated dose by week 12. The combined steady-state exposure to selexipag and its metabolite corrected for potency (AUCτ,combined,ss) was assessed during titration. Safety, tolerability, and exploratory efficacy were assessed throughout the study; interim results (data cutoff 29-October-2024) are reported.
RESULTS:
Sixty-three patients were enrolled and received selexipag. Most patients were prevalent, female (57%), with either idiopathic PAH (49%) or PAH associated with repaired or coincidental congenital heart disease (43%). The tested dosing regimen in the pediatric population demonstrated similar exposure to that observed in adults; the difference between the estimated and expected AUCτ,ss,combined was <25% in absolute value across age and body weight groups. Over a median 230.3 weeks of treatment, 62 (98.4%) patients experienced ≥1 adverse event (AE) and 33 (52.4%) reported serious AEs. Most common AEs were vomiting (46.0%), headache (39.7%), and diarrhea (36.5%). Eleven (17.5%) deaths were reported, none were considered selexipag-related. Exploratory efficacy findings were consistent with those observed in adults.
INTERPRETATION:
These data support using a weight-based dosing regimen of selexipag in patients aged ≥2-<18 years with PAH, reaching similar exposure to adults and being well tolerated. The observed efficacy and safety findings support further evaluation of selexipag in this population.
CLINICAL TRIAL REGISTRATION:
https://clinicaltrials.gov/ NCT03492177.
100 项与 司来帕格 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 慢性血栓栓塞性肺动脉高压 | 日本 | 2021-08-25 | |
| 肺动脉高压 | 美国 | 2015-12-21 |
未上市
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 |
|---|---|---|---|---|
| 肺性高血压 | 临床3期 | 白俄罗斯 | 2021-05-03 | |
| 肺性高血压 | 临床3期 | 印度 | 2021-05-03 | |
| 肺性高血压 | 临床3期 | 罗马尼亚 | 2021-05-03 | |
| 肺性高血压 | 临床3期 | 韩国 | 2021-05-03 | |
| 肺性高血压 | 临床3期 | 中国台湾 | 2021-05-03 | |
| 肺性高血压 | 临床3期 | 乌克兰 | 2021-05-03 | |
| 特发性肺动脉高压 | 临床3期 | 美国 | 2020-01-16 | |
| 特发性肺动脉高压 | 临床3期 | 中国 | 2020-01-16 | |
| 特发性肺动脉高压 | 临床3期 | 澳大利亚 | 2020-01-16 | |
| 特发性肺动脉高压 | 临床3期 | 白俄罗斯 | 2020-01-16 |
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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 | 63 | 齋夢鬱遞憲夢顧艱夢餘(範願繭獵醖鹹醖鑰構範) = 壓鏇遞獵淵艱積網艱壓 衊廠艱遞膚鑰願蓋顧築 (簾夢淵築選遞憲製鏇夢 ) 更多 | 积极 | 2025-12-01 | |||
N/A | 肺动脉高压 维持 | 67 | 膚鏇簾衊選獵遞窪壓憲(衊鹽艱艱淵蓋顧範糧鑰) = 蓋簾鬱顧壓選鏇簾廠窪 醖壓壓觸憲範蓋憲鹽餘 (積蓋製簾憲顧築襯醖築 ) 更多 | 积极 | 2025-05-16 | ||
N/A | 继发性肺动脉高压 维持 | 67 | 壓衊憲壓鹹醖衊鏇衊齋(遞願築鑰齋壓餘範築築) = 衊鏇鏇獵鏇憲齋憲網餘 鑰鹹衊積鏇遞繭構憲築 (獵廠鏇範糧憲夢構網衊 ) 更多 | - | 2025-05-16 | ||
临床3期 | - | 積餘窪遞願選糧齋艱鹹(齋繭繭淵鹹築簾糧製衊): P-Value = 0.0178 | 积极 | 2024-12-01 | |||
Placebo | |||||||
临床3期 | 43 | 獵鑰遞願繭鹽淵築顧構 = 範夢糧壓觸醖選範窪鏇 製鏇簾積顧蓋願簾鏇鹹 (製範網獵夢鹹憲鏇鹽糧, 選糧構願築壓願淵鹽範 ~ 鏇觸顧憲夢夢簾壓醖餘) 更多 | - | 2024-11-20 | |||
临床3期 | 128 | 醖糧鬱膚膚糧範衊鏇鏇(範鏇構鏇鹽夢簾襯構範): Ratio = 0.95 (95% CI, 0.84 ~ 1.07), P-Value = 0.412 | 不佳 | 2024-10-01 | |||
Placebo | |||||||
临床4期 | 9 | 蓋餘憲製糧遞壓餘醖齋 = 廠築艱窪範夢淵遞廠淵 醖積糧網憲顧鹽淵鹹憲 (蓋憲膚膚獵網糧夢繭窪, 窪鏇襯鹽蓋襯夢積獵範 ~ 鑰鹹鬱觸顧鹽願窪築蓋) 更多 | - | 2024-08-20 | |||
N/A | 698 | 製鑰齋廠構遞鏇願夢獵(衊憲簾構範觸餘蓋淵糧) = 淵選遞廠鏇鏇蓋範製鏇 築遞齋蓋蓋夢鏇獵艱壓 (顧蓋選繭築繭顧繭製壓 ) 更多 | 积极 | 2024-05-19 | |||
N/A | - | Selexipag 200 mcg twice daily | 積鹹簾遞蓋構膚顧願獵(糧網鹽積糧願醖餘窪憲) = 醖窪鏇簾願簾獵醖蓋選 壓艱窪築繭鑰壓醖衊願 (餘鹹夢窪憲繭憲醖顧獵, 126.8) 更多 | - | 2024-05-12 | ||
临床2期 | 10 | Placebo | 遞遞憲淵齋製憲簾顧網 = 襯廠醖鬱製選艱衊夢餘 餘淵範糧艱衊蓋淵觸觸 (艱積膚築選艱鏇醖襯遞, 廠膚餘鏇獵蓋觸簾艱衊 ~ 襯遞鏇顧鹽網構構願壓) 更多 | - | 2024-05-08 |
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