曲前列素二乙醇胺(Treprostinil diethanolamine)

概要

基本信息

药物类型

小分子化药

别名

靶点-

作用机制-

治疗领域

呼吸系统疾病其他疾病免疫系统疾病+ [1]

在研适应症-

非在研适应症

指溃疡肺动脉高压系统性硬皮病+ [1]

原研机构-

在研机构-

非在研机构

United Therapeutics Corp.

兆科药业（合肥）有限公司

United Pharmaceuticals SAS

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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关联

18

项与曲前列素二乙醇胺相关的临床试验

CTR20140524 / Completed临床3期

肺动脉高压患者中UT-15C 的开放标签延长期研究

1. 为之前参加评价肺动脉高压患者的UT-15C TDE-PH-310临床试验方案的合格受试者继续提供UT-15C药物治疗。 2. 在口服UT-15C受试者中的长期安全性进行评价。 3. 在长期使用UT-15C 的受试者中，评价持续UT-15C治疗对于运动耐力的影响。

开始日期2014-01-29

申办/合作机构

United Pharmaceuticals SAS

[+1]

CTR20140523 / Completed临床3期

UT-15C在接受口服单药治疗的肺动脉高压受试者中进行的随机双盲安慰剂对照的国际多中心3期临床试验

1.评价PAH受试者中口服UT-15C与安慰剂组相比，对受试者至首次临床恶化时间的影响以及对运动耐力的作用 2.评价PAH受试者中口服UT-15C与安慰剂组相比，对第24周6分钟步行距离较基线的变化进行评判

开始日期2013-08-09

申办/合作机构

United Pharmaceuticals SAS

[+1]

NCT01934582 / Completed临床3期

A Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 Protocol

A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily dosing regimen.

开始日期2013-08-01

申办/合作机构

United Therapeutics Corp.

100 项与曲前列素二乙醇胺相关的临床结果

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100 项与曲前列素二乙醇胺相关的转化医学

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100 项与曲前列素二乙醇胺相关的专利（医药）

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4

项与曲前列素二乙醇胺相关的文献（医药）

2015-01-02·Expert Review of Clinical Pharmacology2区 · 医学

Oral treprostinil diethanolamine for pulmonary arterial hypertension

2区 · 医学

Review

作者: Kirat Gill ; Yunhee Im ; Jeremy Feldman

The approval of oral treprostinil is a landmark event in the treatment of pulmonary arterial hypertension. Nineteen years after epoprostenol was approved we now have an oral prostanoid available in the USA. Although the current data in prostanoid naïve patients are unimpressive, emerging data suggest that in carefully selected patients oral treprostinil may be able to replace continuously infused treprostinil; however, many hurdles exist for this new medication including overcoming a complex side effect profile, astronomical cost and perhaps other entrants into the oral prostanoid space.

2013-04-01·Journal of Cardiovascular Pharmacology4区 · 医学

Pharmacokinetics of Treprostinil Diolamine in Subjects With End-Stage Renal Disease On or Off Dialysis

4区 · 医学

Article

作者: Jenkins, Amanda ; Laliberte, Kevin ; Marbury, Thomas ; Wang-Smith, Laurene

Treprostinil diolamine sustained release (UT-15C SR) is being evaluated as an oral therapy for pulmonary arterial hypertension. This study evaluated the pharmacokinetics (PKs) of treprostinil following administration of UT-15C SR in subjects with end-stage renal disease (ESRD) compared with healthy subjects with normal renal function (NRF) and the effect of hemodialysis on the PK parameters of treprostinil. Eight ESRD subjects (requiring dialysis, mean creatinine clearance = 11.5 mL/min) received 2 single doses of 1 mg of UT-15C SR (separated by 2 weeks), with the first dose given immediately after dialysis and the second given 4 hours before the start of dialysis. Eight NRF subjects received a single dose of 1 mg of UT-15C SR. The median Cmax, AUC0-inf, and t1/2 of treprostinil were 680 pg/mL, 3240 hours pg/mL, and 2.35 hours, respectively, in ESRD subjects dosed after dialysis and were 551 pg/mL, 3152 hours pg/mL, and 2.05 hours, respectively, in ESRD subjects dosed before dialysis. In comparison, corresponding values were 730 pg/mL, 3726 hours pg/mL, and 3.54 hours, respectively, in NRF subjects. UT-15C SR of 1 mg was well tolerated by NRF and ESRD subjects. The most frequent adverse event was headache and nausea. There was no substantial difference in treprostinil PKs between ESRD and NRF subjects following administration of UT-15C SR tablets. Hemodialysis did not have clinically important effect on treprostinil PK in ESRD subjects.

2010-07-01·The Journal of Clinical Pharmacology3区 · 医学

Lack of a Pharmacokinetic Interaction Between Oral Treprostinil and Bosentan in Healthy Adult Volunteers

3区 · 医学

Article

作者: Allen Lai ; David Mottola ; S. Karl Gotzkowsky ; Jasper Dingemanse ; Kevin Laliberte

Treprostinil diethanolamine is an oral prostacyclin analog currently being evaluated for the treatment of pulmonary arterial hypertension (PAH). Treprostinil is metabolized primarily by cytochrome P450 (CYP) 2C8 with minor contribution from CYP2C9. It is expected that oral treprostinil will be administered with bosentan, approved for the treatment of PAH and known to induce CYP2C9 and 3A4. This study evaluated whether a drug interaction exists between oral treprostinil, bosentan, and its active metabolite Ro 48–5033 during co‐administration. Twenty‐four participants were randomized in a 3‐way crossover study to oral treprostinil 1 mg twice daily, bosentan 125 mg twice daily, and oral treprostinil 1 mg twice daily and bosentan 125 mg twice daily. Treprostinil geometric mean ratios (GMRs) (90% confidence interval [CIs]) for steady‐state AUC0–12 and Cmax (combination/treprostinil) were 0.92 (0.83, 1.03) and 0.96 (0.83, 1.11), respectively, whereas bosentan GMRs (combination/bosentan) were 1.02 (0.95, 1.10) and 1.04 (0.94, 1.15), respectively, and Ro 48–5033 GMRs were 0.99 (0.93, 1.06) and 1.03 (0.94, 1.13). In conclusion, because the GMR and 90% CI are within the equivalence interval of 0.8 to 1.25, co‐administration of oral treprostinil and bosentan did not result in a pharmacokinetic interaction for either agent.

100 项与曲前列素二乙醇胺相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肺动脉高压	临床3期	法国	United Pharmaceuticals SAS	2012-07-26
肺动脉高压	临床3期	墨西哥	United Pharmaceuticals SAS	2012-07-26
肺动脉高压	临床3期	希腊	United Pharmaceuticals SAS	2012-07-26
肺动脉高压	临床3期	智利	United Pharmaceuticals SAS	2012-07-26
肺动脉高压	临床3期	瑞典	兆科药业（合肥）有限公司	2012-07-26
肺动脉高压	临床3期	荷兰	United Pharmaceuticals SAS	2012-07-26
肺动脉高压	临床3期	美国	United Pharmaceuticals SAS	2012-07-26
肺动脉高压	临床3期	韩国	兆科药业（合肥）有限公司	2012-07-26
肺动脉高压	临床3期	智利	兆科药业（合肥）有限公司	2012-07-26
肺动脉高压	临床3期	加拿大	兆科药业（合肥）有限公司	2012-07-26

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01934582 (TDE-PH-304, CTgov)	临床3期	肺动脉高压	13	UT-15C SR (treprostinil diethanolamine) (PK Visit 1)	鑰鏇遞壓壓網醖製網醖(鏇鹽膚衊醖鑰積醖衊獵) = 顧繭衊簾簾鬱齋獵繭餘壓鹽製鹽鹹鹹餘願蓋觸 (糧鑰餘鑰鹽繭遞遞鏇簾, 獵餘蓋鹹壓醖壓壓艱築 ~ 齋壓鑰壓鹽鏇憲醖鬱觸) 更多	-	2016-10-27
NCT01934582 (TDE-PH-304, CTgov)	临床3期	肺动脉高压	13	UT-15C SR (treprostinil diethanolamine) (PK Visit 2)	鑰鏇遞壓壓網醖製網醖(鏇鹽膚衊醖鑰積醖衊獵) = 衊廠積餘膚積範繭膚衊壓鹽製鹽鹹鹹餘願蓋觸 (糧鑰餘鑰鹽繭遞遞鏇簾, 鹽廠獵淵糧網鏇艱憲壓 ~ 築獵膚獵蓋鬱艱範範製) 更多	-	2016-10-27
NCT00775463 (DISTOL-1, CTgov)	临床2期	系统性硬皮病 \| 可见病灶	148	treprostinil diethanolamine	艱築夢願網積餘範觸鬱(構簾製願膚夢構餘築築) = 顧淵餘衊淵壓膚繭齋鏇淵鑰顧願膚遞簾襯範憲 (繭鏇齋製衊觸鹹鑰鹹廠, 獵餘觸壓醖築壓壓餘餘 ~ 襯餘壓鹹選糧憲襯齋憲) 更多	-	2014-03-17
NCT00848107 (DISTOL-EXT, CTgov)	临床2期	系统性硬皮病 \| 可见病灶 \| 指溃疡	115	Treprostinil Diethanolamine	鑰構鬱膚糧觸衊積範憲(鹹範範廠夢艱簾簾廠齋) = 遞觸蓋積築選網簾膚壓蓋鬱製壓築襯範獵遞獵 (醖鹽淵淵鏇顧鹹網艱顧, 範廠齋壓製遞齋顧淵範 ~ 構鹹觸艱廠鏇鬱鬱衊齋) 更多	-	2014-02-07