Bosentan

Overview

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Bosentan in the Treatment of Giant Cell Arteritis	2025/05/04	NCT06957002	Phase 2	Not yet recruiting	Assistance Publique - Hôpitaux de Paris
Dual Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)	2025/03/20	NCT06887062	Phase 2	Recruiting	University of Edinburgh
Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets	2024/07/03	NCT06484673	Phase 1	Completed	Humanis Saglık Anonim Sirketi
A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood	2023/02/13	NCT05723874	Phase 1	Completed	Boehringer Ingelheim
Reflex Responses to Intermittent Hypoxia in Humans: Mechanisms and Consequences	2021/12/06	NCT05146089	Early Phase 1	Completed	University of Missouri-Columbia
Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors	2021/10/08	NCT05072106	Phase 1	UNKNOWN	PharmaMar
Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan	2021/08/05	NCT04991207	Phase 1	Completed	Bial - Portela C S.A.
Vascular Dysfunction in Black Individuals: Roles of Nitric Oxide and Endothelin-1	2021/02/25	NCT04770155	Early Phase 1	Terminated	University of Mississippi Medical Center
VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH RESISTANT ARTERIAL HYPERTENSION	2020/05/14	NCT04388124	Phase 2	UNKNOWN	University Hospital, Rouen
Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN	2020/05/07	NCT04379180	N/A	UNKNOWN	Shandong University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Bosentan	Sun Pharmaceutical Industries, Inc.	47335-039	ORAL	125 mg in 1 1	3/5/2024
Tracleer	Actelion Pharmaceuticals US, Inc.	66215-103	ORAL	32 mg in 1 1	2/21/2024
bosentan	Actavis Pharma, Inc.	0591-2512	ORAL	125 mg in 1 1	10/31/2023
bosentan	Actavis Pharma, Inc.	0591-2511	ORAL	62.5 mg in 1 1	10/31/2023
Bosentan	Zydus Lifesciences Limited	70771-1017	ORAL	62.5 mg in 1 1	9/20/2023
Bosentan	Amneal Pharmaceuticals LLC	65162-874	ORAL	125 mg in 1 1	6/18/2019
Bosentan	Sun Pharmaceutical Industries, Inc.	47335-038	ORAL	62.5 mg in 1 1	3/5/2024
Tracleer	Actelion Pharmaceuticals US, Inc.	66215-102	ORAL	125 mg in 1 1	2/21/2024
Bosentan	Amneal Pharmaceuticals LLC	65162-873	ORAL	62.5 mg in 1 1	6/18/2019
Bosentan	Zydus Lifesciences Limited	70771-1018	ORAL	125 mg in 1 1	9/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TRACLEER TABLET 125 mg	PATHEON INC	SIN12543P	TABLET, FILM COATED	125 mg	5/6/2004
PROART FILM COATED TABLETS 62.5MG	SUN PHARMACEUTICAL INDUSTRIES LIMITED	SIN15133P	TABLET, FILM COATED	62.50mg	12/9/2016
PROART FILM COATED TABLETS 125MG	SUN PHARMACEUTICAL INDUSTRIES LIMITED	SIN15132P	TABLET, FILM COATED	125.00mg	12/9/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
BOSENTAN SANDOZ TABLETS 125MG	N/A	Sandoz Hong Kong Limited	N/A	N/A	2/20/2023
SILKAY 125 TABLETS 125MG	N/A	INTERNATIONAL HEALTH ALLIANCE, LLC	N/A	N/A	2/17/2020

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BOSENCIP bosentan 62.5 mg (as monohydrate) tablet bottle	284682	Cipla Australia Pty Ltd	Medicine	A	1/3/2018
BOSENTAN ASTRON Bosentan (as monohydrate) 125 mg film-coated tablets blister pack	235886	Accord Healthcare Pty Ltd	Medicine	A	3/22/2016
BOSENTAN APO bosentan (as monohydrate) 125 mg film-coated tablet bottle	257734	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/11/2016
BOSENTAN RBX bosentan (as monohydrate) 62.5 mg film-coated tablet bottle	257758	Sun Pharma ANZ Pty Ltd	Medicine	A	7/11/2016
BOSENTAN VIATRIS bosentan (as monohydrate) 62.5 mg film-coated tablet blister pack	206775	Alphapharm Pty Ltd	Medicine	A	12/19/2016
BOSENTAS bosentan 125 mg (as monohydrate) tablet bottle	284687	Cipla Australia Pty Ltd	Medicine	A	1/3/2018
BOSENTAN GH bosentan (as monohydrate) 62.5 mg film-coated tablets blister pack	235882	Generic Health Pty Ltd	Medicine	A	3/22/2016
BOSENTAN INTAS Bosentan (as monohydrate) 62.5 mg film-coated tablets bottle pack	235888	Accord Healthcare Pty Ltd	Medicine	A	3/22/2016
BOSENTAN SUN bosentan (as monohydrate) 62.5 mg film-coated tablet bottle	257760	Sun Pharma ANZ Pty Ltd	Medicine	A	7/11/2016
BOSENTAN VIATRIS bosentan (as monohydrate) 125 mg film-coated tablet blister pack	206772	Alphapharm Pty Ltd	Medicine	A	12/19/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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