Bosentan

Mechanism-of-action class: Endothelin Receptor Antagonists.

• Nov 20, 2001NDANDA021290Actelion
• Sep 5, 2017NDANDA209279Actelion
• Apr 26, 2019ANDAANDA207760Zydus Pharms
• Apr 26, 2019ANDAANDA209324Sun Pharm
• Apr 26, 2019ANDAANDA207110Watson Labs Inc
• Feb 5, 2025ANDAANDA213154Natco Pharma Ltd
• Feb 17, 2026ANDAANDA213981Zydus Pharms

1. 1Death9,299—
2. 2Dyspnoea5,993—
3. 3Pneumonia2,693—
4. 4Pulmonary Arterial Hypertension2,290—
5. 5Fatigue2,246—
6. 6Headache2,221—
7. 7Nausea2,063—
8. 8Diarrhoea1,987—
9. 9Condition Aggravated1,869—
10. 10Dizziness1,761—
11. 11Malaise1,702—
12. 12Fall1,568—
13. 13Cough1,551—
14. 14Vomiting1,529—
15. 15Pulmonary Hypertension1,463—

Recent PubMed references pinned to Bosentan as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Bosentan confers cardioprotection against cisplatin toxicity: Involvement of β-arrestin-linked ET(A) receptor signaling.
  Biochemical pharmacology · 2026 · Khine HEE, Mangmool S, Parichatikanond W, et al.
  PMID 42069228DOI 10.1016/j.bcp.2026.118027
• Heterogeneity in the efficacy of bosentan for hypertensive nephropathy: a study on individualized benefit prediction models based on pathological subtyping and dynamic trajectories.
  Annals of medicine · 2026 · Yu X, Gong X, Wang B, et al.
  PMID 41649882DOI 10.1080/07853890.2026.2624240
• Investigation of endothelin-1 receptor antagonist bosentan in a rat endometriosis model.
  Naunyn-Schmiedeberg's archives of pharmacology · 2026 · Karcioglu SS, Halici Z, Cadirci E, et al.
  PMID 41533156DOI 10.1007/s00210-025-04935-w
• Bosentan Delivery via Nano Metal-Organic Framework nanoMIL-89 Restores Vascular Homeostasis in Pulmonary Arterial Hypertension.
  International journal of nanomedicine · 2025 · Al-Badr MA, Abunada HH, Gill R, et al.
  PMID 40955205DOI 10.2147/IJN.S535437
• Predicting Systemic and Liver Bosentan Exposure Using Physiologically-Based Pharmacokinetic Modeling.
  CPT: pharmacometrics & systems pharmacology · 2025 · Huang MC, Macente J, Heylen S, et al.
  PMID 40763914DOI 10.1002/psp4.70085
• Cardioprotective Effects of Bosentan in Rats Subjected to Lung Ischemia-Reperfusion Injury.
  Medicina (Kaunas, Lithuania) · 2025 · Demiröz ŞM, Küçük A, Tekin E, et al.
  PMID 40731929DOI 10.3390/medicina61071298
• Performance of oral Bosentan-loaded SNEDDS and S-SNEDDS tablets: Biodistribution in mice, echocardiography and histology studies in pulmonary arterial hypertension rat model.
  European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2025 · Yilmaz Usta D, Olgac S, Demirel MA, et al.
  PMID 40280258DOI 10.1016/j.ejpb.2025.114725
• Design and rationale of the efficacy of endothelin receptor antagonism in treatment of coronary artery spasm: a randomized controlled trial (EDIT-CAS).
  American heart journal · 2025 · Crooijmans C, Jansen T, van de Hoef T, et al.
  PMID 40274007DOI 10.1016/j.ahj.2025.04.022

The 10 most recently updated of 135 ClinicalTrials.gov registrations naming Bosentan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
  Active not recruiting · Phase 3 · Interventional · 935 enrolled · Actelion
  NCT04273945updated 2026-06-05
• Pulmonary Artery Remodelling With Bosentan
  Completed · Phase 4 · Interventional · 11 enrolled · Actelion
  NCT00595049updated 2026-06-03
• Bosentan in Systemic Sclerosis
  Completed · Phase 4 · Interventional · 18 enrolled · Actelion
  NCT01395732updated 2026-06-03
• Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine (DTIC)
  Completed · Phase 2 · Interventional · 80 enrolled · Actelion
  NCT01009177updated 2026-06-03
• Bosentan in the Treatment of Giant Cell Arteritis
  Not yet recruiting · Phase 2 · Interventional · 40 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT06957002updated 2026-05-06
• Effect of Bosentan in Scleroderma Renal Crisis
  Completed · Phase 2 · Interventional · 16 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT01241383updated 2026-05-01
• Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
  Recruiting · Phase 1 · Interventional · 21 enrolled · City of Hope Medical Center
  NCT04158635updated 2026-04-17
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Observational · 5,000 enrolled · Duke University
  NCT04278404updated 2026-04-06
• A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood
  Completed · Phase 1 · Interventional · 14 enrolled · Boehringer Ingelheim
  NCT05723874updated 2026-03-30
• Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension
  Completed · Phase 3 · Interventional · 28 enrolled · Johns Hopkins University
  NCT04039464updated 2026-02-18

Frequently asked questions

How does Bosentan work?

Mechanism-of-action class: Endothelin Receptor Antagonists.

What class of drug is Bosentan?

Bosentan is classified as Antihypertensives for pulmonary arterial hypertension, Endothelin Receptor Antagonists, Decreased Blood Pressure, Pulmonary Arterial Vasodilation.

What are the brand names for Bosentan?

Bosentan is marketed under brand names including Tracleer.