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.
Background
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 |
|---|---|---|---|---|---|
2025/05/04 | Phase 2 | Not yet recruiting | |||
2025/03/20 | Phase 2 | Recruiting | |||
2024/07/03 | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | ||
2023/02/13 | Phase 1 | Completed | |||
2021/12/06 | Early Phase 1 | Completed | |||
2021/10/08 | Phase 1 | UNKNOWN | PharmaMar | ||
2021/08/05 | Phase 1 | Completed | Bial - Portela C S.A. | ||
2021/02/25 | Early Phase 1 | Terminated | |||
2020/05/14 | Phase 2 | UNKNOWN | University Hospital, Rouen | ||
2020/05/07 | N/A | UNKNOWN | Shandong University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | 47335-039 | ORAL | 125 mg in 1 1 | 3/5/2024 | |
| Actelion Pharmaceuticals US, Inc. | 66215-103 | ORAL | 32 mg in 1 1 | 2/21/2024 | |
| Actavis Pharma, Inc. | 0591-2512 | ORAL | 125 mg in 1 1 | 10/31/2023 | |
| Actavis Pharma, Inc. | 0591-2511 | ORAL | 62.5 mg in 1 1 | 10/31/2023 | |
| Zydus Lifesciences Limited | 70771-1017 | ORAL | 62.5 mg in 1 1 | 9/20/2023 | |
| Amneal Pharmaceuticals LLC | 65162-874 | ORAL | 125 mg in 1 1 | 6/18/2019 | |
| Sun Pharmaceutical Industries, Inc. | 47335-038 | ORAL | 62.5 mg in 1 1 | 3/5/2024 | |
| Actelion Pharmaceuticals US, Inc. | 66215-102 | ORAL | 125 mg in 1 1 | 2/21/2024 | |
| Amneal Pharmaceuticals LLC | 65162-873 | ORAL | 62.5 mg in 1 1 | 6/18/2019 | |
| 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 | SIN12543P | TABLET, FILM COATED | 125 mg | 5/6/2004 | |
| PROART FILM COATED TABLETS 62.5MG | SIN15133P | TABLET, FILM COATED | 62.50mg | 12/9/2016 | |
| PROART FILM COATED TABLETS 125MG | SIN15132P | TABLET, FILM COATED | 125.00mg | 12/9/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bosentan Tablets | mylan s.p.a. | 国药准字HJ20250018 | 化学药品 | 片剂 | 2/11/2025 |
| Bosentan Tablets | mylan s.p.a. | 国药准字HJ20250019 | 化学药品 | 片剂 | 2/11/2025 |
| Bosentan Tablets | dr. reddys laboratories ltd | 国药准字HJ20250001 | 化学药品 | 片剂 | 1/2/2025 |
| Bosentan Tablets | 国药准字H20249140 | 化学药品 | 片剂 | 10/22/2024 | |
| Bosentan Tablets | 国药准字HJ20170013 | 化学药品 | 片剂 | 1/20/2022 | |
| Bosentan Tablets | 国药准字HJ20110291 | 化学药品 | 片剂 | 1/20/2022 | |
| Bosentan Dispersible Tablets | 国药准字HJ20190051 | 化学药品 | 片剂 | 6/18/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BOSENTAN SANDOZ TABLETS 125MG | N/A | N/A | N/A | 2/20/2023 | |
| SILKAY 125 TABLETS 125MG | N/A | N/A | N/A | 2/17/2020 |