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Ambrisentan

Phase 2
GSK plc (GSK)

Phase 2

Development Phase

0

Upcoming Catalysts

0

Historical Events

3

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Hypertension, Pulmonary

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Drug Information

Target Indication

Hypertension, Pulmonary

Clinical Trial

NCT01342952

Last updated: 1/22/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMAPending

Ambrisentan Zentiva

Treatment of pulmonary arterial hypertension.

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EMA6/20/2019

Ambrisentan Viatris (previously Ambrisentan Mylan)

Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.

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EMA4/21/2008

Volibris

Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).  Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).

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Drug Science
Mechanism of action & safety profile
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