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Riociguat (Adempas, BAY63-2521)

Phase 3
BAYER (BAYRY)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

2

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

NCT01065454

Last updated: 12/29/2025

Patent & Exclusivity

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

Regulatory Approvals
EMAPending

Riociguat Accord

Treatment of Chronic thromboembolic pulmonary hypertension (CTEPH) in adults and treatment of Pulmonary arterial hypertension (PAH) in adults and children from 6 years of age.

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EMA3/27/2014

Adempas

Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity. Pulmonary arterial hypertension (PAH) AdultsAdempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. PaediatricsAdempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ? 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.

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Drug Science
Mechanism of action & safety profile
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