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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)

Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor

Phase 3
Completed
Conditions
Hypertension, Pulmonary
Interventions
First Posted Date
2013-12-11
Last Posted Date
2019-02-21
Lead Sponsor
Bayer
Target Recruit Count
61
Registration Number
NCT02007629

Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator

Phase 2
Completed
Conditions
Raynaud Disease
Interventions
First Posted Date
2013-08-21
Last Posted Date
2014-06-16
Lead Sponsor
Bayer
Target Recruit Count
23
Registration Number
NCT01926847

Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Conditions
Hypertension, Pulmonary
First Posted Date
2013-02-06
Last Posted Date
2016-01-06
Lead Sponsor
Bayer
Registration Number
NCT01784562

Relative Bioavailability and Food Effect Study

Phase 1
Completed
Conditions
Pharmacology, Clinical
Interventions
First Posted Date
2011-12-09
Last Posted Date
2015-07-01
Lead Sponsor
Bayer
Target Recruit Count
32
Registration Number
NCT01489488

Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters.

Phase 2
Completed
Conditions
Pulmonary Hypertension
Interventions
First Posted Date
2010-08-11
Last Posted Date
2016-08-29
Lead Sponsor
Bayer
Target Recruit Count
18
Registration Number
NCT01179334
Locations
🇬🇧

Papworth Hospital, Cambridge, Cambridgeshire, United Kingdom

🇨🇿

Vseobecna fakultni nemocnice, Praha 2, Czech Republic

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction

Phase 2
Terminated
Conditions
Ventricular Dysfunction, Left
Hypertension, Pulmonary
Interventions
First Posted Date
2010-07-30
Last Posted Date
2014-11-04
Lead Sponsor
Bayer
Target Recruit Count
39
Registration Number
NCT01172756

Coronary Vasomotor Response After Riociguat Exposure

Phase 2
Withdrawn
Conditions
Coronary Artery Disease
Interventions
First Posted Date
2010-07-20
Last Posted Date
2013-10-23
Lead Sponsor
Bayer
Registration Number
NCT01165931

Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics

Phase 2
Terminated
Conditions
Hypertension, Pulmonary
Ventricular Dysfunction, Left
Interventions
First Posted Date
2010-02-09
Last Posted Date
2014-01-06
Lead Sponsor
Bayer
Target Recruit Count
1
Registration Number
NCT01065051

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

Phase 2
Active, not recruiting
Conditions
Hypertension, Pulmonary
Ventricular Dysfunction, Left
Interventions
First Posted Date
2010-02-09
Last Posted Date
2025-04-23
Lead Sponsor
Bayer
Target Recruit Count
202
Registration Number
NCT01065454

BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension

Phase 3
Completed
Conditions
Pulmonary Hypertension
Interventions
First Posted Date
2009-05-29
Last Posted Date
2023-11-07
Lead Sponsor
Bayer
Target Recruit Count
237
Registration Number
NCT00910429
Locations
🇮🇱

Rabin Medical Center - Beilinson Campus, Petach Tikva, Israel

🇵🇹

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

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