Overview
Ambrisentan is an orally active selective type A endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension. It is approved in Europe, Canada and the United States for use as a single agent to improve exercise ability and delay clinical worsening. In addition, it is approved in the United States for use in combination with tadalafil to reduce the risks of disease progression, hospitalization and to improve exercise ability. Studies establishing the efficacy of Ambrisentan included patients with both idiopathic or heritable pulmonary arterial hypertension and those with pulmonary arterial hypertension associated with connective tissue diseases. Patients studied displayed symptoms and etiologies predominantly of WHO Functional Class II-III. As an endothelin receptor antagonist, Ambrisentan prevents endogenous endothelin peptide from constricting the muscles in blood vessels, allowing them to relax and permit a reduction in blood pressure.
Indication
用于治疗肺动脉高血压(PAH)。
Associated Conditions
- Pulmonary arterial hypertension WHO functional class I
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/23 | Not Applicable | Not yet recruiting | |||
2025/05/13 | Not Applicable | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/02/13 | Phase 2 | Recruiting | |||
2023/10/10 | Phase 2 | Not yet recruiting | |||
2022/06/29 | Phase 3 | Completed | |||
2021/07/22 | Not Applicable | Recruiting | |||
2021/02/25 | Phase 2 | Terminated | |||
2020/08/27 | Phase 1 | UNKNOWN | |||
2020/06/29 | Phase 2 | UNKNOWN | |||
2020/05/19 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Pharmaceuticals Inc. | 0378-4270 | ORAL | 5 mg in 1 1 | 8/15/2019 | |
| Apotex Corp. | 60505-4552 | ORAL | 5 mg in 1 1 | 12/1/2023 | |
| Actavis Pharma, Inc. | 0591-2405 | ORAL | 5 mg in 1 1 | 9/30/2019 | |
| Sigmapharm Laboratories, LLC | 42794-052 | ORAL | 10 mg in 1 1 | 1/10/2023 | |
| Quallent Pharmaceuticals Health LLC | 82009-142 | ORAL | 10 mg in 1 1 | 6/10/2025 | |
| Sun Pharmaceutical Industries, Inc. | 47335-236 | ORAL | 5 mg in 1 1 | 1/30/2024 | |
| Apotex Corp. | 60505-4553 | ORAL | 10 mg in 1 1 | 12/1/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1179 | ORAL | 5 mg in 1 1 | 3/16/2023 | |
| Sigmapharm Laboratories, LLC | 42794-051 | ORAL | 5 mg in 1 1 | 1/10/2023 | |
| Sun Pharmaceutical Industries, Inc. | 47335-237 | ORAL | 10 mg in 1 1 | 1/30/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/20/2008 | ||
Authorised | 4/20/2008 | ||
Authorised | 6/20/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VOLIBRIS FILM-COATED TABLET 5MG | SIN15093P | TABLET, FILM COATED | 5.0 mg | 9/30/2016 | |
| VOLIBRIS FILM-COATED TABLET 10 MG | SIN15094P | TABLET, FILM COATED | 10.0 mg | 9/30/2016 |
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 |
|---|---|---|---|---|---|
| VOLIBRIS TABLETS 10MG | N/A | N/A | N/A | 4/29/2015 | |
| VOLIBRIS TABLETS 5MG | N/A | N/A | N/A | 4/29/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AMBRISENTAN SANDOZ ambrisentan 5 mg film-coated tablet blister pack | 346343 | Medicine | A | 9/20/2021 | |
| PULMORIS ambrisentan 10 mg tablet blister pack | 282337 | Medicine | A | 9/14/2017 | |
| PULMORIS ambrisentan 5 mg tablet blister pack | 282338 | Medicine | A | 9/14/2017 | |
| CIPLA AMBRISENTAN ambrisentan 10 mg tablet blister pack | 282339 | Medicine | A | 9/14/2017 | |
| CIPLA AMBRISENTAN ambrisentan 5 mg tablet blister pack | 282340 | Medicine | A | 9/14/2017 | |
| VOLIBRIS ambrisentan 5mg tablet blister pack | 143743 | Medicine | A | 11/24/2008 | |
| VOLIBRIS ambrisentan 10mg tablet blister pack | 143739 | Medicine | A | 11/24/2008 | |
| AMBRISENTAN VIATRIS ambrisentan 10 mg film-coated tablet blister pack | 298941 | Medicine | A | 4/1/2020 | |
| AMBRICIP ambrisentan 10 mg tablet blister pack | 282330 | Medicine | A | 9/14/2017 | |
| AMBRICIP ambrisentan 5 mg tablet blister pack | 282336 | Medicine | A | 9/14/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SANDOZ AMBRISENTAN | 02525305 | Tablet - Oral | 5 MG | N/A | |
| SANDOZ AMBRISENTAN | 02525313 | Tablet - Oral | 10 MG | N/A | |
| APO-AMBRISENTAN | 02475375 | Tablet - Oral | 5 MG | 11/26/2018 | |
| SANDOZ AMBRISENTAN TABLETS | 02526883 | Tablet - Oral | 10 MG | 10/7/2022 | |
| JAMP AMBRISENTAN | 02521946 | Tablet - Oral | 10 MG | 10/6/2022 | |
| VOLIBRIS | 02307073 | Tablet - Oral | 10 MG | 6/24/2008 | |
| AURO-AMBRISENTAN | auro pharma inc | 02527103 | Tablet - Oral | 10 MG | N/A |
| TEVA-AMBRISENTAN | teva canada limited | 02536242 | Tablet - Oral | 10 MG | N/A |
| M-AMBRISENTAN | mantra pharma inc | 02554089 | Tablet - Oral | 5 MG | N/A |
| SANDOZ AMBRISENTAN TABLETS | 02526875 | Tablet - Oral | 5 MG | 10/7/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| AMBRISENTAN KERN PHARMA 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 85001 | COMPRIMIDO RECUBIERTO | Uso Hospitalario | Commercialized | |
| AMBRISENTAN VIVANTA 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Vivanta Generics S.R.O. | 89411 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized |
| AMBRISENTAN SANDOZ 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 84715 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
| VOLIBRIS 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 108451005 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| AMBRISENTAN DR REDDYS 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Reddy Pharma Iberia S.A. | 84731 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
| AMBRISENTAN AUROVITAS 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 88445 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized |
| AMBRISENTAN KERN PHARMA 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 85000 | COMPRIMIDO RECUBIERTO | Uso Hospitalario | Commercialized | |
| AMBRISENTAN AUROVITAS 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 88446 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized |
| AMBRISENTAN SALA 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Reig Jofre, S.A. | 86091 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized |
| AMBRISENTAN DR. REDDYS 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Reddy Pharma Iberia S.A. | 84730 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
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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