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-

作用方式-

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.

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.

2005-10-01·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials.

Article

作者: Bayes, M ; Prous, J R ; Rabasseda, X

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (-)-Epigallocatechin gallate, (Z)-4-hydroxytamoxifen; Ad.muIFN-beta AD-237, adalimumab, adefovir dipivoxil, agalsidase alfa, alemtuzumab, almotriptan, ALVAC vCP1452, alvimopan hydrate, ambrisentan, anakinra, anti-IFN-gamma MAb; Bimatoprost, BMS-188797, BMS-214662, bortezomib, bosentan, bovine lactoferrin; Caffeine, canertinib dihydrochloride, canfosfamide hydrochloride, cannabidiol, caspofungin acetate, cetuximab, cH36, ChimeriVax-JE, ciclesonide, cilansetron, cinacalcet hydrochloride, clopidogrel, CpG-7909, Cypher; Daptomycin, darbepoetin alfa, darifenacin hydrobromide, decitabine, denufosol tetrasodium, Dexamet, diindolemethane, drotrecogin alfa (activated), duloxetine hydrochloride, DX-9065a; E-7010, edaravone, efalizumab, eicosapentaenoic acid/docosahexaenoic acid, elacridar, eletriptan, emtricitabine, epratuzumab, erlotinib hydrochloride, ertapenem sodium, eszopiclone, everolimus, ezetimibe; Fludarabine, fondaparinux sodium; gamma-Hydroxybutyrate sodium, gavestinel sodium, gefitinib, granisetron-Biochronomer; Human Albumin, human insulin; Imatinib mesylate, indiplon, interleukin-2 XL, isatoribine, ISS-1018, i.v. gamma-globulin, ivabradine hydrochloride, ixabepilone; Lanthanum carbonate, L-arginine hydrochloride, liposomal doxorubicin, LY-450139; Magnesium sulfate, melatonin, motexafin gadolinium, mycophenolic acid sodium salt; Natalizumab, nesiritide, niacin/lovastatin; OGX-011, olmesartan medoxomil, omalizumab, ospemifene; PACAP38, panitumumab, parathyroid hormone (human recombinant), parecoxib sodium, patupilone, pegfilgrastim, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, pirfenidone, posaconazole, prasterone, pregabalin; R-112, ramelteon, ranolazine, rasagiline mesilate, rebimastat, roflumilast, rosuvastatin calcium, rotigotine hydrochloride, rupatadine fumarate; S-3013, S-3304, semustine, sitaxsentan sodium, St. John's Wort extract; Tadalafil, tamoxifen, Taxus, Tc-99m-EDDA-HYNIC-TOC, TH-9507, tiotropium bromide, tipifarnib, tocilizumab, tolvaptan, torcetrapib, TR-14035, tramadol hydrochloride/acetaminophen, treprostinil diethanolamine, troglitazone, troxacitabine; Valdecoxib, valganciclovir hydrochloride, vandetanib, vardenafil hydrochloride hydrate, VAS-991, veglin, vinflunine, voriconazole; White sweet potato extract; Ximelagatran.

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

10 条进展最快的记录,

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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	希腊	兆科药业（合肥）有限公司	2012-07-26
肺动脉高压	临床3期	巴西	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	United Pharmaceuticals SAS	2012-07-26
肺动脉高压	临床3期	印度	兆科药业（合肥）有限公司	2012-07-26
肺动脉高压	临床3期	荷兰	兆科药业（合肥）有限公司	2012-07-26
肺动脉高压	临床3期	新加坡	兆科药业（合肥）有限公司	2012-07-26
肺动脉高压	临床3期	德国	兆科药业（合肥）有限公司	2012-07-26
肺动脉高压	临床3期	英国	兆科药业（合肥）有限公司	2012-07-26
肺动脉高压	临床3期	奥地利	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

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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)	鏇簾遞鏇獵製鹹繭繭獵(顧構構鹽膚積餘製廠蓋) = 觸繭繭觸選襯膚鹹蓋蓋醖繭壓築壓衊艱壓鬱鹹 (願鑰襯襯餘襯艱獵衊製, 衊糧鏇艱衊窪淵衊窪遞 ~ 鏇願顧鑰窪餘糧願廠餘) 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)	鏇簾遞鏇獵製鹹繭繭獵(顧構構鹽膚積餘製廠蓋) = 鑰鑰醖鏇壓簾積觸鹹蓋醖繭壓築壓衊艱壓鬱鹹 (願鑰襯襯餘襯艱獵衊製, 醖壓膚遞製窪衊鑰積窪 ~ 範壓餘艱獵構觸鬱積鏇) 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	壓廠積鏇餘鑰範觸獵繭(鬱餘製窪窪鹹願膚襯製) = 選鑰製衊憲齋蓋範糧鬱膚糧壓簾壓糧襯鏇齋襯 (築願襯襯築膚膚窪糧願, 糧鑰糧繭選觸顧蓋鏇網 ~ 齋鑰壓鹽顧繭選範範壓) 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	鹹獵憲簾遞齋製鬱願衊(鑰顧夢製製夢願鹹鑰繭) = 鏇積網鹽蓋繭願鏇顧觸襯憲醖窪簾範鏇膚窪壓 (範憲夢壓憲鬱襯積積簾, 獵憲選齋繭構遞糧鑰淵 ~ 鹹艱憲製鏇鬱獵蓋窪鏇) 更多	-	2014-02-07