Tracleer

(Bosentan)

ApprovedSmall molecule

Bosentan is used to treat pulmonary arterial hypertension, a condition where blood pressure in the lungs becomes dangerously high, making it harder for the heart to pump blood through the lungs.[2] Tracleer is currently approved and in use across 26 indications[4].[1]

Tracleer is one of 412 small molecule programs targeting Congenital Heart Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

411

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Congenital Heart DiseaseActive, not recruiting

Thromboangiitis ObliteransActive, not recruiting

Persistent Fetal Circulation SyndromeApproved

Hermansky-Pudlak SyndromeApproved

Familial Multiple Nevi FlammeiApproved

MelanomaApproved

Mitral Valve StenosisApproved

Systemic SclerodermaActive, not recruiting

Eisenmenger SyndromeApproved

Anterior Ischemic Optic NeuropathyApproved

Congenital Heart DiseaseApproved

Active, not recruiting

Thromboangiitis ObliteransPreclinical

Active, not recruiting

Persistent Fetal Circulation SyndromeApproved

Approved

Hermansky-Pudlak SyndromeApproved

Approved

Familial Multiple Nevi FlammeiApproved

Approved

MelanomaApproved

Approved

Mitral Valve StenosisApproved

Approved

Systemic SclerodermaApproved

Active, not recruiting

Eisenmenger SyndromeApproved

Approved

Anterior Ischemic Optic NeuropathyApproved

Approved

Showing 10 of 25 indications

Competition

Competitive Landscape

335 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Tracleer

Johnson & Johnson

Approved

1 2

Medrol

Pfizer

Preclinical

1 3

Byetta

AstraZeneca

Preclinical

1 4

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 6

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Active Comparator

Moderna

Preclinical

1 9

Sulfonylureas

Eli Lilly

Preclinical

1 10

Concurrent Lenvatinib

TTrans Tasman Radiation Oncology Group

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2029

Phase 2Not yet recruiting

Giant Cell Arteritis

NCT06957002

Clinical

Trials by Indication[1]

Pulmonary Arterial Hypertension16 trials

Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00323297·105 enrolled

Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients With Pulmonary Arterial Hypertension (PAH)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00310830·14 enrolled

Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00303459·334 enrolled

Show 13 more trials

Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00091715·185 enrolled

Early Therapy of Pulmonary Arterial Hypertension

Completed·MMedical University of Graz·N/A·NCT00909337·10 enrolled

Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan

Withdrawn·RRajan Saggar·Phase 4·NCT00625469

Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants

Completed· Novartis logo

Novartis·Phase 3·NCT01392469·21 enrolled

Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00319020·33 enrolled

Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01223352·64 enrolled

A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

Unknown status·HHamilton Health Sciences Corporation·Phase 3·NCT00864201·10 enrolled

Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE

Unknown status·—·Phase 2·NCT01827059·12 enrolled

The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00302211·67 enrolled

Combination Therapy in Pulmonary Arterial Hypertension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00433329·100 enrolled

Insulin Resistance in Pulmonary Arterial Hypertension

Terminated·SStanford University·Phase 2·NCT00825266·2 enrolled

Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00317486·54 enrolled

Bosentan in Children With Pulmonary Arterial Hypertension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00319267·36 enrolled

Pulmonary Hypertension6 trials

A Study of Patients Having Pulmonary Hypertension Associated With Sickle Cell Disease and Completing an ASSET Study

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00360087·236 enrolled

Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients Diagnosed With Pulmonary Hypertension (PH)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00313196·12 enrolled

Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

Completed·UUniversity of Cincinnati·Phase 2/3·NCT00581607·43 enrolled

Show 3 more trials

Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients

Unknown status·—·Phase 3·NCT01712997·90 enrolled

Persistent Pulmonary Hypertension of the Newborn

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01389856·23 enrolled

Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia

Unknown status·—·Phase 4·NCT01449253·60 enrolled

BOS6 trials

Effects of Bosentan on Respiratory Mechanics

Terminated·IIRCCS Azienda Ospedaliero-Universitaria di Bologna·Phase 4·NCT00679068·4 enrolled

ENDOTHELION Study Group: Effect of Bosentan in NAION Patients

Unknown status·UUniversity Hospital, Grenoble·Phase 3·NCT02377271·86 enrolled

A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT07081932·16 enrolled

Show 3 more trials

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

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT05723874·14 enrolled

Safety of Bosentan in Type II Diabetic Patients

Completed·RRetinset SL·Phase 1·NCT04068272·22 enrolled

Bosentan in Digital Ulcers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00319696·116 enrolled

Systemic Sclerosis4 trials

Bosentan in Systemic Sclerosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01395732·18 enrolled

Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis

Completed·HHeinrich-Heine University, Duesseldorf·Phase 2·NCT00318175·10 enrolled

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

Completed·UUniversity Medical Center Groningen·Phase 4·NCT02480335·20 enrolled

Show 1 more trial

Treatment of Early Systemic Sclerosis by Bosentan

Terminated·RRikshospitalet University Hospital·Phase 1/2·NCT00226889·30 enrolled

Single ventricle3 trials

Endothelin Blockade in Patients With Single Ventricle Physiology

Completed·UUniversity of California, Los Angeles·N/A·NCT00989911·10 enrolled

Bosentan Therapy in Children With Functional Single Ventricle

Completed·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT01662037·34 enrolled

Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.

Completed·RRigshospitalet, Denmark·Phase 2·NCT01292551·75 enrolled

36 more indications

Scleroderma3 trials

Effect of Bosentan in Scleroderma Renal Crisis

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT01241383·16 enrolled

Placebo Controlled Trial of Bosentan in Scleroderma Patients

Terminated·GGeorgetown University·Phase 2·NCT00377455·5 enrolled

Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00077584·188 enrolled

Tics3 trials

Influence of OATP1B1 and CYP2C9 Genotypes on the Pharmacokinetics of Bosentan Before and During Clarithromycin

Completed·GGerd Mikus··NCT01425229·16 enrolled

Influence of Bosentan on the Pharmacokinetics of Nintedanib

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02667704·13 enrolled

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

Completed·BBial - Portela C S.A.·Phase 1·NCT04991207·44 enrolled

Hypertension3 trials

Endothelin-1 Receptor Blockade in Resistant Hypertension

Recruiting·UUniversity Hospital, Rouen·Phase 2·NCT04388124·24 enrolled

Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 1·NCT00260819·20 enrolled

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 enrolled

Interstitial Lung Disease3 trials

BUILD 3: Bosentan Use in Interstitial Lung Disease

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00391443·616 enrolled

Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment Study

Unknown status·RRoyal Brompton & Harefield NHS Foundation Trust·Phase 4·NCT00637065·48 enrolled

Open-label Study With Bosentan in Interstitial Lung Disease

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2/3·NCT00319033·132 enrolled

CLE3 trials

The Effect of Tracleer® on Male Fertility

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00082186·22 enrolled

Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects

Completed·GGeropharm·Phase 1·NCT04101370·64 enrolled

Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT06484673·32 enrolled

Asthma2 trials

Examination of the Bronchoprotective Effect of Endothelin Receptor Blockade in Asthma

Unknown status·UUniversity of Glasgow·Phase 2·NCT01617746·18 enrolled

Bosentan for Poorly Controlled Asthma

Terminated·UUConn Health·Phase 2·NCT00815347·11 enrolled

Chronic Thromboembolic Pulmonary Hypertension2 trials

Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00313222·157 enrolled

Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00319111·151 enrolled

Idiopathic Pulmonary Fibrosis2 trials

Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2/3·NCT00071461·158 enrolled

Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00631475·128 enrolled

Function2 trials

Endothelin Receptor Function and Acute Stress

Active, not recruiting·—·N/A·NCT02116335·320 enrolled

Bosentan for Severe Mitral Valve Dysfunction

Unknown status·—·Phase 1/2·NCT01270750·10 enrolled

Exercise2 trials

ET-blockade and Exercise Induced Blood Flow in T2DM

Completed·RRadboud University Medical Center·Phase 4·NCT01779596·22 enrolled

ET-blockade and Exercise-induced Vascular Adaptations in T2DM

Completed·RRadboud University Medical Center·Phase 4·NCT01779609·19 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients

Unknown status·—·Phase 2·NCT02093195·40 enrolled

Pulmonary Fibrosis1 trial

Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2/3·NCT00070590·132 enrolled

Clinical Trial1 trial

Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Bosentan After Oral Administration

Unknown status·DDong-A Pharmaceutical Co., Ltd.·Phase 1·NCT01929213·30 enrolled

Pilot Study1 trial

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

Completed·—·Phase 2·NCT02317679·4 enrolled

Endothelial Function1 trial

Bosentan and Pulmonary Endothelial Function

Completed·PProf David S Celermajer·N/A·NCT01721564·8 enrolled

Thromboangiitis Obliterans1 trial

Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan

Completed·HHospital Universitario Getafe··NCT01447550·12 enrolled

Diastolic Heart Failure1 trial

Safety and Efficacy of Bosentan in Patients With Diastolic Heart Failure and Secondary Pulmonary Hypertension

Completed·—·Phase 3·NCT00820352·20 enrolled

Glaucoma1 trial

Effects of Non-Specific Endothelin-A Receptor Blockade on Ocular Blood Flow in Patients With Glaucoma

Completed·MMedical University of Vienna·Phase 1·NCT00701597·28 enrolled

Vascular Disease1 trial

Bosentan for Mild Pulmonary Vascular Disease in Asd Patients.

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 3·NCT01218607·10 enrolled

Sleep Apnea1 trial

Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea

Completed·UUniversity Hospital, Grenoble·Phase 2·NCT00777985·19 enrolled

Prolonged1 trial

Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration

Completed·CCenter for Health Sciences, Serbia·Phase 2/3·NCT01352065·30 enrolled

Hepatopulmonary Syndrome1 trial

Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis

Terminated·MMedical University of Vienna·Phase 2·NCT01518595·6 enrolled

Giant Cell Arteritis1 trial

Bosentan in the Treatment of Giant Cell Arteritis

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06957002·40 enrolled

Vascular Dysfunction1 trial

Vascular Dysfunction in Black Individuals: Roles of Nitric Oxide and Endothelin-1

Terminated·UUniversity of Mississippi Medical Center·Phase 1·NCT04770155·8 enrolled

Oral1 trial

Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Unknown status·SShandong University··NCT04379180·500 enrolled

Hypoxia1 trial

Reflex Responses to Intermittent Hypoxia in Humans: Mechanisms and Consequences

Completed·UUniversity of Missouri-Columbia·Phase 1·NCT05146089·54 enrolled

Peripheral Arterial Disease1 trial

Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease

Completed·HHospital Universitario Getafe·N/A·NCT01738542·30 enrolled

Pulmonary Sarcoidosis1 trial

Safety and Efficacy Study of Bosentan in Progressive Pulmonary Sarcoidosis

Terminated·DDaniel Doberer·Phase 2·NCT00926627·32 enrolled

Patients With Advanced Solid Tumors1 trial

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

Completed·PPharmaMar·Phase 1·NCT05072106·11 enrolled

Type 2 Diabetes1 trial

Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes

Completed·KKarolinska Institutet·Phase 2·NCT01357109·56 enrolled

Metastatic Melanoma1 trial

Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine (DTIC)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01009177·80 enrolled

Diabetic Nephropathy1 trial

Bosentan Use in Patients With Diabetic Nephropathy

Terminated·—·Phase 3·NCT00638131·1 enrolled

ART1 trial

Pulmonary Artery Remodelling With Bosentan

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00595049·11 enrolled

Congenital Heart Disease1 trial

Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery

Unknown status·BBerto J Bouma·N/A·NCT01184404·100 enrolled

Pancreatic Cancer1 trial

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

Recruiting·—·Phase 1·NCT04158635·21 enrolled

Unspecified3 trials

Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3)

Completed·UUniversity of Edinburgh·Phase 1·NCT01100736·10 enrolled

FUTURE 3 Study Extension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01338415·58 enrolled

The Effect of Multiple Oral Doses of Bosentan on the Single Oral Dose Pharmacokinetics of Zongertinib in Healthy Male Subjects (an Open-label, Two-treatment, Two-period Fixed Sequence Trial)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT07649941·16 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 20, 2001

TRACLEER

NDA NDA021290

Sep 5, 2017

TRACLEER

NDA NDA209279

Sources

References

[1]
ClinicalTrials.gov — 88 trial records for Bosentan. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tracleer drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bosentan compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bosentan. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209279). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tracleer. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Endothelin Receptor, ET-A/ET-B Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Johnson & Johnson

Patent Landscape[6]

Patent Cliff

Dec 28, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8309126May 15, 2026

7959945Dec 28, 2027

Tracleer

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2029

Trials by Indication[1]

Pulmonary Arterial Hypertension16 trials

Pulmonary Hypertension6 trials

BOS6 trials

Systemic Sclerosis4 trials

Single ventricle3 trials

Scleroderma3 trials

Tics3 trials

Hypertension3 trials

Interstitial Lung Disease3 trials

CLE3 trials

Asthma2 trials

Chronic Thromboembolic Pulmonary Hypertension2 trials

Idiopathic Pulmonary Fibrosis2 trials

Function2 trials

Exercise2 trials

Chronic Obstructive Pulmonary Disease1 trial

Pulmonary Fibrosis1 trial

Clinical Trial1 trial

Pilot Study1 trial

Endothelial Function1 trial

Thromboangiitis Obliterans1 trial

Diastolic Heart Failure1 trial

Glaucoma1 trial

Vascular Disease1 trial

Sleep Apnea1 trial

Prolonged1 trial

Hepatopulmonary Syndrome1 trial

Giant Cell Arteritis1 trial

Vascular Dysfunction1 trial

Oral1 trial

Hypoxia1 trial

Peripheral Arterial Disease1 trial

Pulmonary Sarcoidosis1 trial

Patients With Advanced Solid Tumors1 trial

Type 2 Diabetes1 trial

Metastatic Melanoma1 trial

Diabetic Nephropathy1 trial

ART1 trial

Congenital Heart Disease1 trial

Pancreatic Cancer1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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