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)
A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH)
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- First Posted Date
- 2021-03-24
- Last Posted Date
- 2025-02-10
- Lead Sponsor
- Bayer
- Target Recruit Count
- 500
- Registration Number
- NCT04813926
- Locations
- 🇺🇸
Cedar Sinai, Los Angeles, California, United States
🇺🇸Northwestern, Chicago, Illinois, United States
🇺🇸UCSF, Fresno, California, United States
THERAPY-HYBRID-BPA Trial
- First Posted Date
- 2020-10-23
- Last Posted Date
- 2020-10-23
- Lead Sponsor
- National Hospital Organization Okayama Medical Center
- Target Recruit Count
- 72
- Registration Number
- NCT04600492
- Locations
- 🇯🇵
National Hospital Org anization Okayama Medical Center, Okayama, Japan
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Impaired Liver Function and Healthy Participants Matched for Age-, Gender-, and Weight
- First Posted Date
- 2020-04-29
- Last Posted Date
- 2020-04-29
- Lead Sponsor
- Bayer
- Target Recruit Count
- 32
- Registration Number
- NCT04366622
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
- First Posted Date
- 2020-04-28
- Last Posted Date
- 2020-04-28
- Lead Sponsor
- Bayer
- Target Recruit Count
- 40
- Registration Number
- NCT04364464
A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2019-12-26
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- Actelion
- Target Recruit Count
- 47
- Registration Number
- NCT04211272
- Locations
- 🇧🇪
Clinical Pharmacology Unit, Merksem, Belgium
Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- First Posted Date
- 2019-08-20
- Last Posted Date
- 2025-02-20
- Lead Sponsor
- University of Arizona
- Target Recruit Count
- 20
- Registration Number
- NCT04062565
- Locations
- 🇺🇸
University of Arizona, Tucson, Arizona, United States
Upfront Combination Pulmonary Arterial Hypertension Therapy
- First Posted Date
- 2019-01-18
- Last Posted Date
- 2020-03-26
- Lead Sponsor
- University of Calgary
- Target Recruit Count
- 20
- Registration Number
- NCT03809156
- Locations
- 🇨🇦
Vancouver General Hospital, The Lung Centre, Vancouver, British Columbia, Canada
🇨🇦Peter Lougheed Center, Calgary, Alberta, Canada
Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty
- Conditions
- Chronic Thromboembolic Disease (CTED)Exercise Intolerance Post PEA Surgery
- Interventions
- First Posted Date
- 2018-01-24
- Last Posted Date
- 2024-05-23
- Lead Sponsor
- University of Colorado, Denver
- Target Recruit Count
- 20
- Registration Number
- NCT03409588
- Locations
- 🇺🇸
University of Colorado, Anschutz Medical Campus, Aurora, Colorado, United States
Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics
- Conditions
- Healthy Subjects
- Interventions
- First Posted Date
- 2018-01-03
- Last Posted Date
- 2018-02-08
- Lead Sponsor
- Actelion
- Target Recruit Count
- 20
- Registration Number
- NCT03389321
- Locations
- 🇩🇪
CRS Clinical Research Services Mannheim, Mannheim, Germany
Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)
- Conditions
- Chronic Thromboembolic Pulmonary HypertensionCTEPH
- Interventions
- First Posted Date
- 2017-09-06
- Last Posted Date
- 2021-06-22
- Lead Sponsor
- International CTEPH Association
- Target Recruit Count
- 14
- Registration Number
- NCT03273257
- Locations
- 🇺🇸
UC San Diego, La Jolla, California, United States
🇬🇧Papworth Hospital, Cambridge, United Kingdom
🇫🇷Hopital de Bicêtre, Paris, France
Drug Development Updates
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