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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-Discontinue Effects on Right HEART in CTEPH (RED-HEART)

Phase 3
Recruiting
Conditions
Chronic Thromboembolic Pulmonary Hypertension
Interventions
Drug: Routine Treatment
First Posted Date
2025-04-10
Last Posted Date
2025-04-30
Lead Sponsor
Suqiao Yang
Target Recruit Count
68
Registration Number
NCT06922240
Locations
🇨🇳

China-Japan Friendship Hospital, Beijing, China

🇨🇳

Beijing Anzhen Hospital, Beijing, China

🇨🇳

Beijing Chao-Yang Hospital, Beijing, China

Sildenafil Switching to Riociguat

Phase 4
Recruiting
Conditions
Chronic Thromboembolic Pulmonary Hypertension
Balloon Pulmonary Angioplasty
Interventions
First Posted Date
2024-12-04
Last Posted Date
2024-12-04
Lead Sponsor
Chinese University of Hong Kong
Target Recruit Count
30
Registration Number
NCT06715280
Locations
🇭🇰

Prince of Wales Hospital, Hong Kong, Hong Kong

Bioequivalence Study of Riociguat 2.5 mg Film Coated Tablets and Adempas (Riociguat) 2.5 mg Film Coated Tablets

Phase 1
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2023-12-22
Last Posted Date
2023-12-28
Lead Sponsor
Humanis Saglık Anonim Sirketi
Target Recruit Count
36
Registration Number
NCT06180096
Locations
🇮🇳

Cliantha Research Limited, Ahmedabad, Gujarat, India

Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

Phase 4
Recruiting
Conditions
Pulmonary Arterial Hypertension
Interventions
Device: CardioMEMS pulmonary artery pressure monitor
Device: Confirm Rx
First Posted Date
2023-04-24
Last Posted Date
2024-12-03
Lead Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Target Recruit Count
40
Registration Number
NCT05825417
Locations
🇬🇧

Sheffield Teaching Hospitals NHS FT, Sheffield, United Kingdom

Networked Drug REpurposing for Mechanism-based neuroPrOtection in Acute Ischaemic STROKE

Phase 2
Recruiting
Conditions
Ischemic Stroke, Acute
Interventions
First Posted Date
2023-03-09
Last Posted Date
2023-10-19
Lead Sponsor
Maastricht University
Target Recruit Count
28
Registration Number
NCT05762146
Locations
🇩🇪

University Hospital Essen, Department of Neurology, Essen, Germany

Effect of Riocigaut on Migraine Attack Induction in People With Migraine

Not Applicable
Completed
Conditions
Migraine Without Aura
Interventions
First Posted Date
2023-03-01
Last Posted Date
2024-07-12
Lead Sponsor
Danish Headache Center
Target Recruit Count
22
Registration Number
NCT05750446
Locations
🇩🇰

Danish Headache Center, Copenhagen, Glostrup, Denmark

Effect of Riocigaut on Cerebral Vasodilation and Headache Induction in Healthy Volunteers

Not Applicable
Completed
Conditions
Headache
Interventions
Drug: Dose Riociguat 2,5 or 5mg
Drug: Placebo
First Posted Date
2022-10-17
Last Posted Date
2024-01-05
Lead Sponsor
Danish Headache Center
Target Recruit Count
15
Registration Number
NCT05582811
Locations
🇩🇰

Danish Headache Center, Copenhagen, Glostrup, Denmark

Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH

Phase 2
Recruiting
Conditions
Pulmonary Vascular Disorder
Systemic Sclerosis
Other Systemic Involvement of Connective Tissue
Primary Pulmonary Hypertension
Interventions
First Posted Date
2022-04-21
Last Posted Date
2024-12-16
Lead Sponsor
Heidelberg University
Target Recruit Count
70
Registration Number
NCT05339087
Locations
🇦🇹

LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Pulmonologie, Graz, Austria

🇦🇹

Ordensklinikum Linz GmbH Elisabethinen, Linz, Austria

🇫🇷

Centre de référence des Maladies Auto-Immunes Systémiques rares du Nord et Nord-Ouest (CeRAINO) Service de Médecine Interne et Immunologie Clinique Hôpital Claude Huriez, CHU, Lille, France

and more 5 locations

Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH

Phase 3
Recruiting
Conditions
CTEPH
Interventions
Device: balloon pulmonary angioplasty
First Posted Date
2021-12-01
Last Posted Date
2025-02-27
Lead Sponsor
Dr Sudarshan Rajagopal
Target Recruit Count
15
Registration Number
NCT05140525
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH

Phase 4
Recruiting
Conditions
Primary Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Interventions
First Posted Date
2021-07-08
Last Posted Date
2024-03-15
Lead Sponsor
Heidelberg University
Target Recruit Count
30
Registration Number
NCT04954742
Locations
🇩🇪

Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University Hospital, Heidelberg, Germany

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