Bosentan

Generic Name: Bosentan

Brand Names: Stayveer, Tracleer

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₂₉N_₅O_₆S

CAS Number: 147536-97-8

Unique Ingredient Identifier: XUL93R30K2

Background: Bosentan is a dual endothelin receptor antagonist marketed under the trade name Tracleer by Actelion Pharmaceuticals. Bosentan is used to treat pulmonary hypertension by blocking the action of endothelin molecules that would otherwise promote narrowing of the blood vessels and lead to high blood pressure.

Indication: Used in the treatment of pulmonary arterial hypertension (PAH), to improve exercise ability and to decrease the rate of clinical worsening (in patients with WHO Class III or IV symptoms).

Associated Conditions: NYHA Functional Class II-IV Pulmonary arterial hypertension, Ocular Inflammation, Ocular bacterial infections

Associated Therapies: -

Clinical Trials

A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BI 425809
Drug: bosentan

First Posted Date: 2023-02-13

Last Posted Date: 2023-06-06

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 14

Registration Number: NCT05723874

Locations: 🇩🇪
Humanpharmakologisches Zentrum Biberach, Biberach, Germany

Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors

Phase 1

Conditions: Advanced Solid Tumor

Interventions: Drug: Lurbinectedin
Drug: Bosentan

First Posted Date: 2021-10-08

Last Posted Date: 2021-10-08

Lead Sponsor: PharmaMar

Target Recruit Count: 8

Registration Number: NCT05072106

Locations: 🇪🇸
Fundación Jiménez Diaz, Madrid, Spain
🇪🇸
Hospital de Sanchinarro, Madrid, Spain

Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan

Phase 1

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: BIA 5-1058
Drug: bosentan

First Posted Date: 2021-08-05

Last Posted Date: 2021-08-05

Lead Sponsor: Bial - Portela C S.A.

Target Recruit Count: 44

Registration Number: NCT04991207

Locations: 🇩🇪
PAREXEL International - Early Phase Clinical Unit - Berlin, Berlin, Germany

VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH RESISTANT ARTERIAL HYPERTENSION

Phase 2

Conditions: Resistant Hypertension

Interventions: Drug: Bosentan
Drug: Placebo

First Posted Date: 2020-05-14

Last Posted Date: 2020-05-14

Lead Sponsor: University Hospital, Rouen

Target Recruit Count: 24

Registration Number: NCT04388124

Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer

Phase 1

Recruiting

Conditions: Unresectable Pancreatic Carcinoma
Stage IV Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8

Interventions: Drug: Bosentan
Drug: Gemcitabine
Drug: Nab-paclitaxel
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2019-11-12

Last Posted Date: 2024-08-09

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 21

Registration Number: NCT04158635

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Safety of Bosentan in Type II Diabetic Patients

Phase 1

Completed

Conditions: Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Bosentan

First Posted Date: 2019-08-28

Last Posted Date: 2023-02-16

Lead Sponsor: Retinset SL

Target Recruit Count: 22

Registration Number: NCT04068272

Locations: 🇪🇸
Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain
🇪🇸
IOBA, Valladolid, Spain

Influence of Bosentan on the Pharmacokinetics of Nintedanib

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Nintedanib
Drug: Bosentan

First Posted Date: 2016-01-29

Last Posted Date: 2017-04-13

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 13

Registration Number: NCT02667704

Locations: 🇩🇪
Boehringer Ingelheim Investigational Site, Biberach, Germany

The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis

Phase 4

Completed

Conditions: Scleroderma, Systemic

Interventions: Drug: bosentan

First Posted Date: 2015-06-24

Last Posted Date: 2018-12-13

Lead Sponsor: University Medical Center Groningen

Target Recruit Count: 20

Registration Number: NCT02480335

Locations: 🇳🇱
University Medical Center Groningen, Groningen, Netherlands

ENDOTHELION Study Group: Effect of Bosentan in NAION Patients

Phase 3

Recruiting

Conditions: Ischemic Optic Neuropathy

Interventions: Drug: placebo
Drug: bosentan

First Posted Date: 2015-03-03

Last Posted Date: 2022-07-07

Lead Sponsor: University Hospital, Grenoble

Target Recruit Count: 86

Registration Number: NCT02377271

Locations: 🇫🇷
Centre National d'Ophtalmologie XV-XX, Paris, France
🇫🇷
University hospital of Saint-Etienne, Saint-Etienne, France
🇫🇷
University Hospital of Grenoble Michallon, Grenoble, France

and more 4 locations

Treatment of Resistant Port-wine Stains With Bosentan and Pulsed Dye Laser: a Pilot Study

Phase 2

Completed

Conditions: Port-wine Stains

Interventions: Drug: Bosentan
Device: Pulsed dye laser (PDL)

First Posted Date: 2014-12-16

Last Posted Date: 2018-02-05

Lead Sponsor: Centre Hospitalier Universitaire de Nice

Target Recruit Count: 4

Registration Number: NCT02317679

Locations: 🇫🇷
CHU de Nice - Dermatologie - Hôpital Archet, Nice, Alpes-maritimes, France

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