TheraRadar
Data updated: Jun 28, 2026

BOSENTAN

Cardiovascular Approved 2001-11-20
Jump to: Indications Approvals Trials Competitors Safety Patents
6
Indications
--
Phase 3 Trials
24
Years on Market

Details

Status
Prescription
First Approved
2001-11-20
Routes
ORAL
Dosage Forms
TABLET, TABLET, FOR SUSPENSION

Companies

PH HEALTH Viatris NATCO PHARMA WATSON LABS INC CHARTWELL MOLECULAR Hikma ALVOGEN PINE BROOK ZYDUS PHARMS ALEMBIC Sun Pharma AMNEAL PHARMS
Active Ingredient: BOSENTAN

BOSENTAN Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
134 FDA actions from 2019 to 2026
Jun 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Label · Labeling

What BOSENTAN Treats

6 FDA approvals

Originally approved for its first indication in 2019 . Covers 6 distinct patient populations.

  • Other (6)
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Clinical Trial Registry

33 trials
Trial Sponsor ID Phase Status Title
NCT06957002 BOSICART P200041 2024-517030-17 Ph 2 not yet recruiting Bosentan in the Treatment of Giant Cell Arteritis
NCT01241383 ScS-REINBO P081217 Ph 2 completed Effect of Bosentan in Scleroderma Renal Crisis
NCT04158635 21314 NCI-2021-06609, 19312 Ph 1 suspended Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
NCT05723874 results posted 1346-0056 2021-006676-17 Ph 1 completed A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood
NCT04388124 ENDOTHELIN-2 2018/0350/HP Ph 2 recruiting Endothelin-1 Receptor Blockade in Resistant Hypertension
NCT07081932 1305-0113 2025-521104-21-00, U1111-1321-0860 Ph 1 completed A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood
NCT05072106 results posted PM1183-A-019-20 Ph 1 completed Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors
NCT01338415 FUTURE 3 Ext results posted AC-052-374 2010-021793-12 Ph 3 completed FUTURE 3 Study Extension
NCT01223352 FUTURE 3 results posted AC-052-373 Ph 3 completed Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
NCT00631475 BUILD OL results posted AC-052-322 Ph 3 completed Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
NCT01389856 FUTURE 4 results posted AC-052-391 Ph 3 terminated Persistent Pulmonary Hypertension of the Newborn
NCT01395732 HOME AC-052-427 Ph 4 completed Bosentan in Systemic Sclerosis
NCT04068272 BOSRET IOBA-02-2016 Ph 1 completed Safety of Bosentan in Type II Diabetic Patients
NCT04991207 BIA-51058-107 2015-004350-17 Ph 1 completed Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan
NCT01392469 results posted CQTI571A2102 2010-021344-17 Ph 3 completed Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants
NCT00638131 BOS-ND-2007 Ph 3 terminated Bosentan Use in Patients With Diabetic Nephropathy
NCT02480335 CEASESTIFF NL49919.042.14 Ph 4 completed The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis
NCT02317679 13-PP-10 Ph 2 completed Treatment of Resistant Port-wine Stains With Bosentan and Pulsed Dye Laser: a Pilot Study
NCT02667704 results posted 1199.239 2015-003819-38 Ph 1 completed Influence of Bosentan on the Pharmacokinetics of Nintedanib
NCT00825266 results posted SU-09052008-1295 IRB#7432 Ph 2 terminated Insulin Resistance in Pulmonary Arterial Hypertension
NCT01518595 1-Fuhrmann Ph 2 terminated Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis
NCT00926627 BOPSAC EudraCT - 2007-005117-18 Ph 2 terminated Safety and Efficacy Study of Bosentan in Progressive Pulmonary Sarcoidosis
NCT01779609 ET-EX-TRAINING Ph 4 completed ET-blockade and Exercise-induced Vascular Adaptations in T2DM
NCT01779596 ET-EX-ACUTE Ph 4 completed ET-blockade and Exercise Induced Blood Flow in T2DM
NCT00679068 525FSM Ph 4 terminated Effects of Bosentan on Respiratory Mechanics
NCT00820352 BADDHY BO-001 EUDRACT Number: 2008-005514-40 Ph 3 completed Safety and Efficacy of Bosentan in Patients With Diastolic Heart Failure and Secondary Pulmonary Hypertension
NCT01218607 BOMPA UZL-S52480 Ph 3 completed Bosentan for Mild Pulmonary Vascular Disease in Asd Patients.
NCT01352065 ERAATH CHS-ERA-2011 Ph 2, Ph 3 completed Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration
NCT01292551 TEMPO TEMPO study 2010-022389-28 Ph 2 completed Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
NCT00581607 BOSAPAH BOSAPAH-1 7-3-22-1 Ph 2, Ph 3 completed Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
NCT00815347 results posted 08-287-1 001 Ph 2 terminated Bosentan for Poorly Controlled Asthma
NCT01662037 SJTUMS-20120314 Ph 2 completed Bosentan Therapy in Children With Functional Single Ventricle
NCT07649941 1479-0047 U1111-1325-4206, 2025-523193-16 Ph 1 not yet recruiting A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BOSENTAN FDA Label Details

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TRACLEER

Full clinical data, patents, trials, and competitive landscape for bosentan.

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Data Sources

FDA Approval: ANDA205699 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.