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 Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice
- First Posted Date
- 2015-09-10
- Last Posted Date
- 2017-05-24
- Lead Sponsor
- Bayer
- Target Recruit Count
- 125
- Registration Number
- NCT02545465
Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)
- First Posted Date
- 2015-04-29
- Last Posted Date
- 2024-01-29
- Lead Sponsor
- Bayer
- Target Recruit Count
- 882
- Registration Number
- NCT02428985
- Locations
- 🇯🇵
Many Locations, Multiple Locations, Japan
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
- Conditions
- Scleroderma, Systemic
- Interventions
- Drug: Placebo
- First Posted Date
- 2014-11-05
- Last Posted Date
- 2020-02-05
- Lead Sponsor
- Bayer
- Target Recruit Count
- 121
- Registration Number
- NCT02283762
- Locations
- 🇨🇦
Mount Sinai Hospital, Toronto, Ontario, Canada
🇦🇺Royal Perth Hospital, Perth, Western Australia, Australia
🇬🇧Hope Hospital, Salford, Manchester, United Kingdom
Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)
- First Posted Date
- 2014-07-16
- Last Posted Date
- 2017-10-13
- Lead Sponsor
- Bayer
- Target Recruit Count
- 75
- Registration Number
- NCT02191137
Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients
- Conditions
- Cystic Fibrosis
- Interventions
- Drug: Placebo
- First Posted Date
- 2014-06-23
- Last Posted Date
- 2023-11-07
- Lead Sponsor
- Bayer
- Target Recruit Count
- 21
- Registration Number
- NCT02170025
Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women
- Conditions
- Drug Interactions
- Interventions
- Drug: Microgynon
- First Posted Date
- 2014-06-09
- Last Posted Date
- 2015-08-14
- Lead Sponsor
- Bayer
- Target Recruit Count
- 31
- Registration Number
- NCT02159326
Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)
- Conditions
- Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary
- Interventions
- Drug: Placebo
- First Posted Date
- 2014-05-15
- Last Posted Date
- 2017-12-04
- Lead Sponsor
- Bayer
- Target Recruit Count
- 147
- Registration Number
- NCT02138825
- Locations
- 🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸Columbia University Medical Center, New York, New York, United States
🇺🇸Via Christi Clinic, Wichita, Kansas, United States
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )
- First Posted Date
- 2014-04-21
- Last Posted Date
- 2024-04-11
- Lead Sponsor
- Bayer
- Target Recruit Count
- 1298
- Registration Number
- NCT02117791
EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
- First Posted Date
- 2014-03-20
- Last Posted Date
- 2019-06-19
- Lead Sponsor
- Bayer
- Target Recruit Count
- 1316
- Registration Number
- NCT02092818
Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude
- First Posted Date
- 2013-12-31
- Last Posted Date
- 2017-04-12
- Lead Sponsor
- Richard Moon
- Target Recruit Count
- 28
- Registration Number
- NCT02024386
- Locations
- 🇺🇸
Duke Center for Hyperbaric Medicine and Environmental Physiology, Trent Drive, Building CR2, Room 0584, Box 3823,, Durham, North Carolina, United States
Drug Development Updates
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