Delving into the Latest Updates on Treprostinil diethanolamine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target-

Action-

Mechanism-

Therapeutic Areas

Respiratory DiseasesOther DiseasesImmune System Diseases+ [1]

Active Indication-

Inactive Indication

Digital ulcerPulmonary Arterial HypertensionScleroderma, Systemic+ [1]

Originator Organization-

Active Organization-

Inactive Organization

United Therapeutics Corp.

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

United Pharmaceuticals SAS

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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1. To continue to provide UT-15C medication to eligible subjects who were previously enrolled in the UT-15C TDE-PH-310 clinical trial protocol evaluating patients with pulmonary hypertension. 2. To evaluate the long-term safety of UT-15C in subjects taking UT-15C orally. 3. To evaluate the effect of continued UT-15C treatment on exercise tolerance in subjects who have been using UT-15C for a long time.

Start Date29 Jan 2014

Sponsor / Collaborator

United Pharmaceuticals SAS

[+1]

CTR20140523

/ CompletedPhase 3

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

[Translation] A randomized, double-blind, placebo-controlled, international, multicenter phase 3 clinical trial of UT-15C in subjects with pulmonary arterial hypertension receiving oral monotherapy

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

[Translation]

1. To evaluate the effect of oral UT-15C on the time to first clinical deterioration and exercise endurance in PAH subjects compared with the placebo group. 2. To evaluate the change in 6-minute walk distance from baseline at week 24 in PAH subjects compared with the placebo group.

Start Date09 Aug 2013

Sponsor / Collaborator

United Pharmaceuticals SAS

[+1]

NCT01934582

/ CompletedPhase 3

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.

Start Date01 Aug 2013

Sponsor / Collaborator

United Therapeutics Corp.

100 Clinical Results associated with Treprostinil diethanolamine

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100 Translational Medicine associated with Treprostinil diethanolamine

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100 Patents (Medical) associated with Treprostinil diethanolamine

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4

Literatures (Medical) associated with Treprostinil diethanolamine

02 Jan 2015·Expert Review of Clinical PharmacologyQ2 · MEDICINE

Oral treprostinil diethanolamine for pulmonary arterial hypertension

Q2 · MEDICINE

Review

Author: 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.

01 Jul 2010·The Journal of Clinical PharmacologyQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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.

01 Oct 2005·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials.

Article

Author: 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 Deals associated with Treprostinil diethanolamine

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Arterial Hypertension	Phase 3	Greece	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	26 Jul 2012
Pulmonary Arterial Hypertension	Phase 3	Brazil	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	26 Jul 2012
Pulmonary Arterial Hypertension	Phase 3	Canada	United Pharmaceuticals SAS	26 Jul 2012
Pulmonary Arterial Hypertension	Phase 3	India	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	26 Jul 2012
Pulmonary Arterial Hypertension	Phase 3	Netherlands	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	26 Jul 2012
Pulmonary Arterial Hypertension	Phase 3	Singapore	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	26 Jul 2012
Pulmonary Arterial Hypertension	Phase 3	Germany	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	26 Jul 2012
Pulmonary Arterial Hypertension	Phase 3	United Kingdom	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	26 Jul 2012
Pulmonary Arterial Hypertension	Phase 3	Austria	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	26 Jul 2012
Pulmonary Arterial Hypertension	Phase 3	Chile	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	26 Jul 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01934582 (TDE-PH-304, CTgov)	Phase 3	Pulmonary Arterial Hypertension	13	UT-15C SR (treprostinil diethanolamine) (PK Visit 1)	lojafytqpf(yzdlijrbjz) = oghltbeyqd kdpsghjvel (gvmookgexe, admiszzysf - dvgyqrhyla) View more	-	27 Oct 2016
NCT01934582 (TDE-PH-304, CTgov)	Phase 3	Pulmonary Arterial Hypertension	13	UT-15C SR (treprostinil diethanolamine) (PK Visit 2)	lojafytqpf(yzdlijrbjz) = ysbzjtyhff kdpsghjvel (gvmookgexe, xrbygvebvi - ajmmedttah) View more	-	27 Oct 2016
NCT00775463 (DISTOL-1, CTgov)	Phase 2	Scleroderma, Systemic \| Visible Lesion	148	treprostinil diethanolamine	tnozznpwzh(gdazhmmtkh) = iyuoepfvau bguprizgms (fzmpjqivjg, frgxqvoeko - jeaetfoovi) View more	-	17 Mar 2014
NCT00848107 (DISTOL-EXT, CTgov)	Phase 2	Scleroderma, Systemic \| Visible Lesion \| Digital ulcer	115	Treprostinil Diethanolamine	idwofpljtj(gohsjtofll) = wsisgdnmze kguqzqpjcy (uyimyfqvhn, spyojmirat - gxdpieejqj) View more	-	07 Feb 2014