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Adempas, riociguat (BAY 63-2521)

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Company Bayer AG
DescriptionOral soluble guanylyl cyclase (sGC) stimulator
Molecular Target Soluble guanylyl cyclase (sGC)
Mechanism of ActionGuanylyl cyclase activator
Therapeutic ModalityBiologic: Enzyme
Latest Stage of DevelopmentApproved
Standard IndicationHypertension
Indication DetailsTreat chronic thromboembolic pulmonary hypertension (CTEPH); Treat pulmonary arterial hypertension (PAH); Treat pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH); Treat pulmonary hypertension (PH) due to interstitial lung disease; Treat pulmonary hypertension (PH) with left heart disease (LHD); Treat pulmonary hypertension in chronic obstructive pulmonary disease (COPD)
Regulatory Designation

U.S. - Orphan Drug (Treat chronic thromboembolic pulmonary hypertension (CTEPH));
U.S. - Orphan Drug (Treat pulmonary arterial hypertension (PAH));
U.S. - Orphan Drug (Treat pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH));
U.S. - Priority Review (Treat chronic thromboembolic pulmonary hypertension (CTEPH));
U.S. - Priority Review (Treat pulmonary arterial hypertension (PAH));
EU - Orphan Drug (Treat chronic thromboembolic pulmonary hypertension (CTEPH));
EU - Orphan Drug (Treat pulmonary arterial hypertension (PAH));
EU - Standard Review (Treat pulmonary arterial hypertension (PAH));
EU - Standard Review (Treat chronic thromboembolic pulmonary hypertension (CTEPH));
EU - Standard Review (Treat pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH));
Japan - Orphan Drug (Treat chronic thromboembolic pulmonary hypertension (CTEPH));
Japan - Standard Review (Treat chronic thromboembolic pulmonary hypertension (CTEPH));
Australia - Orphan Drug (Treat pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH));
Canada - Standard Review (Treat chronic thromboembolic pulmonary hypertension (CTEPH));
Switzerland - Orphan Drug (Treat chronic thromboembolic pulmonary hypertension (CTEPH));
Switzerland - Orphan Drug (Treat pulmonary arterial hypertension (PAH))

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