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Riociguat

Generic Name
Riociguat
Brand Names
Adempas
Drug Type
Small Molecule
Chemical Formula
C20H19FN8O2
CAS Number
625115-55-1
Unique Ingredient Identifier
RU3FE2Y4XI
Background

Riociguat is a soluble guanylate cyclase (sGC) agonist approved in the USA, Europe and several other regions for patients with group I PAH (pulmonary arterial hypertension) in WHO FC II or III; and for the treatment of patients with inoperable CTEPH (chronic thromboembolic pulmonary hypertension), or persistent/recurrent PH (pulmonary hypertension) after pulmonary endarterectomy in WHO FC II or III. Riociguat is marketed under the brand Adempas® by Bayer HealthCare Pharmaceuticals. Treatment with riociguat costs USD $7,500 for 30 days of treatment.

Indication

Riociguat is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class.

Riociguat is indicated for the treatment of adults with pulmonary arterial hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening. Efficacy was shown in patients on Riociguat monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).

Associated Conditions
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Arterial Hypertension (PAH)

BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension

Phase 3
Completed
Conditions
Hypertension, Pulmonary
Interventions
First Posted Date
2009-03-18
Last Posted Date
2023-11-07
Lead Sponsor
Bayer
Target Recruit Count
396
Registration Number
NCT00863681
Locations
🇵🇹

Centro Hospitalar de Lisboa Norte - Hospital Santa Maria, Lisboa, Portugal

🇲🇽

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico

🇲🇽

Pulmocritic, Guadalajara, Jalisco, Mexico

Effect of Riociguat on Bone Metabolism

Phase 1
Completed
Conditions
Pharmacology, Clinical
Interventions
First Posted Date
2009-03-04
Last Posted Date
2016-01-11
Lead Sponsor
Bayer
Target Recruit Count
17
Registration Number
NCT00855660

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.

Phase 3
Completed
Conditions
Pulmonary Hypertension
Interventions
First Posted Date
2009-03-04
Last Posted Date
2023-11-21
Lead Sponsor
Bayer
Target Recruit Count
262
Registration Number
NCT00855465
Locations
🇫🇷

Hopital Antoine Beclere, Clamart Cedex, France

🇨🇿

Vseobecna fakultni nemocnice, Praha 2, Czechia

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)

Phase 3
Completed
Conditions
Pulmonary Hypertension
Interventions
First Posted Date
2008-12-18
Last Posted Date
2023-11-22
Lead Sponsor
Bayer
Target Recruit Count
445
Registration Number
NCT00810693
Locations
🇦🇺

Royal Hobart Hospital, Hobart, Tasmania, Australia

Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID

Phase 1
Completed
Conditions
Hypertension, Pulmonary
Interventions
First Posted Date
2008-05-20
Last Posted Date
2015-12-16
Lead Sponsor
Bayer
Target Recruit Count
7
Registration Number
NCT00680654

Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.

Phase 1
Completed
Conditions
Hypertension, Pulmonary
Pulmonary Disease, Chronic Obstructive
Interventions
First Posted Date
2008-03-21
Last Posted Date
2016-12-28
Lead Sponsor
Bayer
Target Recruit Count
23
Registration Number
NCT00640315

An Open Multiple Dose Titration Study In Patients With Pulmonary Hypertension

Phase 2
Completed
Conditions
Hypertension, Pulmonary
Interventions
First Posted Date
2007-03-30
Last Posted Date
2015-10-16
Lead Sponsor
Bayer
Target Recruit Count
75
Registration Number
NCT00454558
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