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)
Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension
- Conditions
- Sleep Disordered BreathingChronic Thromboembolic Pulmonary Hypertension
- Interventions
- First Posted Date
- 2017-03-08
- Last Posted Date
- 2023-03-14
- Lead Sponsor
- Medical University of Vienna
- Target Recruit Count
- 50
- Registration Number
- NCT03074539
- Locations
- 🇦🇹
Medical Unviersity Vienna, Vienna, Austria
Riociguat in Scleroderma Associated Digital Ulcers
- First Posted Date
- 2016-09-27
- Last Posted Date
- 2019-09-24
- Lead Sponsor
- Dinesh Khanna, MD, MS
- Target Recruit Count
- 17
- Registration Number
- NCT02915835
- Locations
- 🇺🇸
Georgetown University, Washington, District of Columbia, United States
🇺🇸Hospital of Special Surgery (HSS), New York, New York, United States
🇺🇸University of Michigan, Ann Arbor, Michigan, United States
Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- First Posted Date
- 2016-09-08
- Last Posted Date
- 2021-02-26
- Lead Sponsor
- Bayer
- Target Recruit Count
- 225
- Registration Number
- NCT02891850
A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.
- Conditions
- Hypertension, Pulmonary
- Interventions
- First Posted Date
- 2016-05-03
- Last Posted Date
- 2024-08-16
- Lead Sponsor
- Bayer
- Target Recruit Count
- 25
- Registration Number
- NCT02759419
Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
- Conditions
- Hypertension, PulmonaryHeart Failure With Normal Ejection Fraction
- Interventions
- Drug: Placebo
- First Posted Date
- 2016-04-20
- Last Posted Date
- 2020-11-04
- Lead Sponsor
- Medical University of Vienna
- Target Recruit Count
- 118
- Registration Number
- NCT02744339
- Locations
- 🇦🇹
Medical University of Vienna, Vienna, Austria
A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases
- First Posted Date
- 2015-12-17
- Last Posted Date
- 2023-07-19
- Lead Sponsor
- Mark Gladwin
- Target Recruit Count
- 130
- Registration Number
- NCT02633397
- Locations
- 🇺🇸
Ohio State University, Columbus, Ohio, United States
🇺🇸New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States
🇺🇸UPMC Division of Hematology and Oncology, Pittsburgh, Pennsylvania, United States
Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension
- Interventions
- Procedure: Balloon Pulmonary Angioplasty (BPA)
- First Posted Date
- 2015-12-17
- Last Posted Date
- 2021-01-26
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Target Recruit Count
- 105
- Registration Number
- NCT02634203
- Locations
- 🇫🇷
AP-HP, Bicêtre Hospital, Le Kremlin Bicetre, France
Riociguat for Sarcoidosis Associated Pulmonary Hypertension
- First Posted Date
- 2015-12-09
- Last Posted Date
- 2015-12-09
- Lead Sponsor
- University of Cincinnati
- Target Recruit Count
- 60
- Registration Number
- NCT02625558
- Locations
- 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States
Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
- Conditions
- Hypertension, Pulmonary
- Interventions
- First Posted Date
- 2015-09-29
- Last Posted Date
- 2025-05-06
- Lead Sponsor
- Bayer
- Target Recruit Count
- 24
- Registration Number
- NCT02562235
- Locations
- 🇩🇪
Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany
🇩🇪Universitätsklinikum Ulm, Ulm, Baden-Württemberg, Germany
🇭🇺Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet, Budapest, Hungary
Interaction With HIV Antiretroviral Agents
- Conditions
- HIV-DDI
- Interventions
- First Posted Date
- 2015-09-22
- Last Posted Date
- 2017-12-06
- Lead Sponsor
- Bayer
- Target Recruit Count
- 40
- Registration Number
- NCT02556268
Drug Development Updates
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