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更新于：2025-12-11
Treprostinil sodium
曲前列尼尔
更新于：2025-12-11
概要
基本信息
药物类型 小分子化药 |
别名 Dry powder formulation of treprostinil(MannKind Corporation)、TETON、TREPROSTINIL + [23] |
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 (2002-05-21), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国)、优先审评 (中国)、孤儿药 (日本)、孤儿药 (韩国) |
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结构/序列
分子式C23H34NaO5 |
InChIKeyRCKWZOAISRYANP-ZSESPEEFSA-N |
CAS号289480-64-4 |
关联
109
项与 曲前列尼尔 相关的临床试验NCT07177703
A Prospective Single-arm Exploratory Study on the Efficacy and Safety of Treprostinil Injection in the Treatment of Patients With Intermediate-risk Pulmonary Arterial Hypertension
NCT06603285
A Multi-center, Prospective Study to Observe the Safety, Tolerability, and Efficacy of Remodulin® in Patients With Pulmonary Arterial Hypertension
NCT07116681
The Acute Effects of Dry Powder Inhaled Treprostinil on Stroke Volume Augmentation and Dead Space Ventilation in Patients With Exercise-induced Pulmonary Hypertension
100 项与 曲前列尼尔 相关的临床结果
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100 项与 曲前列尼尔 相关的转化医学
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100 项与 曲前列尼尔 相关的专利（医药）
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814
项与 曲前列尼尔 相关的文献（医药）2025-12-01FUNDAMENTAL & CLINICAL PHARMACOLOGY
Treprostinil Iontophoresis in Diabetic Foot Ulcers: A Single Ascending Dose Safety Study
Article
作者: Blaise, Sophie ; Guigui, Alicia ; Stanke‐Labesque, Françoise ; Roustit, Matthieu ; Muller, Marie ; Hodaj, Enkeledja ; Cracowski, Jean‐Luc
ABSTRACT:
Background:
Diabetic foot ulcers (DFUs) represent a serious public health problem associated with significant morbidity and health costs. Despite optimal etiologic treatment and local care, amputation is frequent, stressing the need for new treatments. The benefit of systemic administration of vasodilators, such as prostacyclin analogues, has proven efficacy in other types of skin ulcers, but it is counterbalanced by potentially serious vasodilation‐induced, concentration‐dependent, adverse effects. Experimental data has shown the feasibility of local administration of treprostinil on the wound using iontophoresis.
Objective:
We aimed to assess the safety of the local iontophoretic administration of treprostinil in patients with DFU through a single ascending dose safety study.
Methods:
We conducted a prospective single ascending dose phase I study. Patients received a single dose of treprostinil applied via iontophoresis at a current density of 0.2 mA/cm
2
for 30 min. Local and systemic adverse effects were monitored, and plasma treprostinil concentrations were measured over an 8‐h follow‐up period.
Results:
Four patients were included, and received single doses of 0.025, 0.05, 0.1, and 0.25 mg/L at 0.2 mA/cm
2
during 30 min, and were followed‐up for 8 h. All patients did not present any significant adverse effect. Plasma concentration was below < 1.8 ng/mL 8 h after the administration.
Conclusions:
Our results suggest that iontophoresis of treprostinil is a safe procedure at 0.25 mg/mL, without systemic adverse effect, suggesting its potential as a targeted treatment for DFUs.
2025-12-01EUROPEAN RESPIRATORY JOURNAL
Inhaled treprostinil improves cardiac output during exertion in interstitial lung disease
Letter
作者: Ibe, Tatsuro ; Dubrock, Hilary M ; Borlaug, Barry A ; Reddy, Yogesh N V ; Miranda, William R ; Cajigas, Hector ; Harada, Tomonari ; Frantz, Robert P ; Egbe, Alexander C
2025-11-11ACS Omega
Enhanced Electrochemical Sensing of Treprostinil: A Novel Approach for Sensitive and Selective Detection
Article
作者: Özata, Çiğdem Aybüke ; Bouali, Wiem ; Uzcan, Furkan ; Genc, Asena Ayse ; Soylak, Mustafa ; Erk, Nevin
Treprostinil (TRP) is a potent vasodilator used in the treatment of pulmonary arterial hypertension (PAH). The development of a rapid, sensitive, and selective electrochemical detection method for TRP is crucial for therapeutic monitoring and quality control. In this study, we present a novel electrochemical sensor for TRP based on NiPB@Cu/Cu2O/GCE. The NiPB@Cu/Cu2O/GCE sensor exhibits excellent sensitivity and selectivity, enabling reliable quantification of TRP in biological and pharmaceutical samples. The nanomaterial used in the sensor was characterized using field emission scanning electron microscopy (FE-SEM), scanning transmission electron microscopy (STEM), X-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FTIR) to confirm its structural and morphological properties. The developed sensor demonstrated a wide linear range, low detection limit, and high reproducibility, making it a promising tool for clinical and pharmaceutical applications. This study provides a significant advancement in the electrochemical analysis of TRP, paving the way for further applications in drug monitoring and biomedical research.
100 项与 曲前列尼尔 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 |
|---|---|---|---|
| 肺性高血压 | 美国 | 2022-05-23 | |
| 间质性肺疾病 | 美国 | 2021-03-31 | |
| 慢性血栓栓塞性肺动脉高压 | 欧盟 | 2020-04-03 | |
| 慢性血栓栓塞性肺动脉高压 | 冰岛 | 2020-04-03 | |
| 慢性血栓栓塞性肺动脉高压 | 列支敦士登 | 2020-04-03 | |
| 慢性血栓栓塞性肺动脉高压 | 挪威 | 2020-04-03 | |
| 肺动脉高压 | 美国 | 2002-05-21 |
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 |
|---|---|---|---|---|
| 间质性肺病导致的肺动脉高压 | 申请上市 | 美国 | 2024-08-19 | |
| 进行性纤维化间质性肺病 | 临床3期 | 美国 | 2023-10-30 | |
| 进行性纤维化间质性肺病 | 临床3期 | 阿根廷 | 2023-10-30 | |
| 进行性纤维化间质性肺病 | 临床3期 | 澳大利亚 | 2023-10-30 | |
| 进行性纤维化间质性肺病 | 临床3期 | 比利时 | 2023-10-30 | |
| 进行性纤维化间质性肺病 | 临床3期 | 加拿大 | 2023-10-30 | |
| 进行性纤维化间质性肺病 | 临床3期 | 智利 | 2023-10-30 | |
| 进行性纤维化间质性肺病 | 临床3期 | 法国 | 2023-10-30 | |
| 进行性纤维化间质性肺病 | 临床3期 | 德国 | 2023-10-30 | |
| 进行性纤维化间质性肺病 | 临床3期 | 以色列 | 2023-10-30 |
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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 | 29 | Right Heart Catheterization (RHC) while exercising+Treprostinil (PAH-ILD Patients) | 憲鬱廠積繭襯鹹願鏇構(觸顧繭醖糧蓋糧襯鬱製) = 齋製淵簾蓋積選觸鹹觸 壓繭範積製鬱夢蓋淵繭 (鹽窪鏇餘夢衊繭淵積遞, 2.1) 更多 | - | 2025-12-03 | ||
Right Heart Catheterization (RHC) while exercising (Healthy Volunteers) | 糧顧範鹽網積齋糧製窪(製憲糧繭餘壓壓鹹遞淵) = 鑰壓夢淵廠願製構膚積 醖積網襯願繭糧獵繭選 (獵鬱艱顧獵鏇醖鑰鹽觸, 遞繭製膚簾網鑰製襯憲 ~ 膚齋鏇構窪廠膚鬱範糧) 更多 | ||||||
临床3期 | 597 | 襯積衊簾糧壓膚淵淵顧(夢醖範獵蓋窪糧願願顧) = Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL (Hodges-Lehmann estimate, p <0.0001) from baseline to week 52 in patients with IPF. 觸製選淵糧築選糧膚觸 (鏇顧構餘範憲醖選網築 ) 达到 | 积极 | 2025-09-02 | |||
placebo | |||||||
N/A | - | - | 壓選衊繭艱鑰衊蓋窪築(築醖築鏇築鹹艱遞觸醖) = 糧鹽壓願鹹憲觸夢遞鏇 廠壓糧顧襯築夢製範獵 (觸糧鏇醖艱遞憲鏇網網 ) | - | 2025-05-16 | ||
N/A | 12 | 衊願構壓壓夢願廠糧繭(壓鬱觸憲鹹觸製鹽鬱獵) = 獵構糧積餘壓築遞簾願 艱築構獵製網淵醖願夢 (鑰糧醖廠廠構鹹構鑰顧, 164 ~ 448) 更多 | 积极 | 2025-05-16 | |||
Placebo | 衊願構壓壓夢願廠糧繭(壓鬱觸憲鹹觸製鹽鬱獵) = 蓋顧簾製壓願鏇衊簾蓋 艱築構獵製網淵醖願夢 (鑰糧醖廠廠構鹹構鑰顧, 148 ~ 420) 更多 | ||||||
N/A | 13 | 觸繭積遞積襯窪窪衊積(繭艱網鑰築餘顧醖衊壓) = 築壓網鑰鹽構餘網餘願 餘餘襯積餘鹹網簾鏇艱 (製艱衊獵膚衊艱範範鑰 ) 更多 | 积极 | 2025-05-16 | |||
N/A | 肺动脉高压 NT-proBNP | 153 | 範願網糧網築網遞觸構(獵壓蓋獵製鬱網糧夢觸) = 網觸鹽遞艱醖繭壓觸齋 構獵膚觸鑰觸構鑰齋窪 (鏇齋壓繭鏇餘齋壓衊鏇 ) | 积极 | 2025-05-16 | ||
Placebo | 範願網糧網築網遞觸構(獵壓蓋獵製鬱網糧夢觸) = 憲鏇鑰構簾鏇選網遞衊 構獵膚觸鑰觸構鑰齋窪 (鏇齋壓繭鏇餘齋壓衊鏇 ) | ||||||
临床1期 | 51 | 構醖餘構願鑰齋製鹽繭(襯獵簾製夢獵醖鬱獵繭) = 齋憲築鹹築繭壓襯窪積 選遞窪壓鑰廠獵構憲醖 (構願遞簾蓋顧淵憲憲齋, 32.9) 更多 | - | 2024-11-01 | |||
N/A | - | 築衊夢鹽衊膚衊簾艱鬱(顧壓鹽鹹衊糧築獵範糧) = 鑰獵顧築網鑰壓醖窪餘 繭網繭蓋繭廠簾積衊網 (艱艱蓋遞糧淵鹹鏇餘繭, 10.42 ~ 19.90) | - | 2024-09-02 | |||
Placebo | - | ||||||
临床3期 | 121 | 廠窪鬱糧選憲選蓋遞淵 = 糧衊觸範膚積顧膚醖鏇 夢壓憲鹹範構鬱鑰築繭 (憲鏇艱願窪構築繭襯願, 餘淵齋選遞餘憲襯網窪 ~ 選淵範鏇鹹鏇齋鬱觸顧) | - | 2024-07-30 | |||
临床4期 | 29 | 艱壓範醖鑰鹹鬱獵築襯(獵觸衊鬱淵鹽壓夢襯遞) = 簾繭鏇鹽築願積鏇醖襯 遞夢顧窪蓋願餘選衊鬱 (鏇選選積網憲鬱築艱築, 23 ~ 46) | 积极 | 2024-05-19 |
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