Bosentan clinical trials
Bosentan is named as an intervention in 4 current clinical trials in our France and Netherlands registers. 1 is recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Assistance Publique - Hôpitaux de Paris (1). The most-studied condition is Giant Cell Arteritis (GCA).
Where Bosentan is approved
All regulators →Of the three regulators tracked here, the first to approve Bosentan was the US, on 20 Nov 2001. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of idiopathic pulmonary fibrosis (5 Sep 2008, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Bosentan patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Bosentan, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 28 Dec 2027 (US 7959945).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Bosentan
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Bosentan works
All drug targets →- Endothelin receptor, ET-A/ET-B antagonist AntagonistTarget: Endothelin receptor, ET-A/ET-B✓ In ChEMBL and the Guide to Pharmacology
- BlindnessPhase 3
- Eisenmenger syndromePhase 3
- Chronic thromboembolic pulmonary hypertensionPhase 3
- Diabetic kidney diseasePhase 3
- Idiopathic pulmonary fibrosisPhase 3
- Persistent fetal circulation syndromePhase 3
- Sickle cell diseasePhase 3
- Temporal arteritisPhase 3
- Ulcer diseasePhase 3
- Interstitial lung diseasePhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL957, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 3494, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Bosentan
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 12 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Bosentan
- ATC code
- C02KX01
- ChEMBL
- CHEMBL957
- DrugBank
- DB00559
- PubChem CID
- 104865
- CAS number
- 147536-97-8
- FDA UNII
- XUL93R30K2
- Wikidata
- Q419769
- Wikipedia
- Bosentan
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Bosentan
4 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Endothelin-1 Receptor Blockade in Resistant Hypertension
NCT04388124 · ClinicalTrials.gov ↗ · Resistant Hypertension
|
Phase 2 | Recruiting | University Hospital, Rouen | France |
|
Bosentan in the Treatment of Giant Cell Arteritis
NCT06957002 · ClinicalTrials.gov ↗ · Giant Cell Arteritis (GCA)
|
Phase 2 | Not yet open | Assistance Publique - Hôpitaux de Paris | France |
|
Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm
NCT06432452 · ClinicalTrials.gov ↗ · Coronary Spasm
|
Phase 2/3 | By invitation | Radboud University Medical Center | Netherlands |
|
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
NCT02377271 · ClinicalTrials.gov ↗ · Ischemic Optic Neuropathy
|
Phase 3 | Active, closed | University Hospital, Grenoble | France |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Bosentan across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
12 single-substance products containing Bosentan on the HPRA medicines list.
- STAYVEER 125 mg film-coated tabletsJanssen Pharmaceutica NV · EU/1/13/832/002
- STAYVEER 62.5 mg film-coated tabletsJanssen Pharmaceutica NV · EU/1/13/832/001
- Tracleer 125 mg film-coated tabletsJanssen-Cilag International NV · EU/1/02/220/004
- Tracleer 125 mg film-coated tabletsJanssen-Cilag International NV · EU/1/02/220/005
- Tracleer 32 mg dispersible tabletsJanssen-Cilag International NV · EU/1/02/220/006
Supply shortages
No entry for Bosentan in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- BosentanFDA · 17 Feb 2026 · Generic (ANDA) · Zydus Pharms
- BosentanFDA · 26 Apr 2019 · Generic (ANDA) · Amneal Pharms Co
Conditions studied with Bosentan
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Assistance Publique - Hôpitaux de Paris | 1 |
| University Hospital, Grenoble | 1 |
| University Hospital, Rouen | 1 |
| Radboud University Medical Center | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in France | 3 | 1 |
| Clinical trials in Netherlands | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Bosentan trials
How many clinical trials are testing Bosentan?
4 current trials in our France and Netherlands registers name Bosentan as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Bosentan trials recruiting patients?
Yes. 1 of the 4 trials is recruiting: 1 with sites in France. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Bosentan clinical trials?
Assistance Publique - Hôpitaux de Paris (1), University Hospital, Grenoble (1), University Hospital, Rouen (1) and Radboud University Medical Center (1). The number in brackets is how many trials each organisation leads.
Is Bosentan licensed in Ireland?
Yes. The HPRA medicines list includes 12 single-substance products containing Bosentan, for example STAYVEER 125 mg film-coated tablets (Janssen Pharmaceutica NV). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Bosentan shortage?
Not in the lists we track: Bosentan has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Bosentan works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Bosentan works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Bosentan (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.