Product Description
Riociguat is a first-in-class medication and the only approved treatment for both PAH and CTEPH. In clinical trials, riociguat has demonstrated favorable efficacy and tolerability. Riociguat is a valuable addition to the armamentarium of options for treating patients with PH. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/33084500/)
Mechanisms of Action: sGC Stimulant
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: Hypertension | Hypertension, Pulmonary
Known Adverse Events: Hypotension | Dizziness | Headache | Gastritis | Gastroesophageal Reflux | Anemia | Constipation | Diarrhea | Dyspepsia
Company: Elanco Animal Health
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Czech Republic, Germany, India, Italy, Japan, United States
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Hypertension, Pulmonary
Phase 2: Familial Primary Pulmonary Hypertension|Resistant Hypertension|Scleroderma, Diffuse|Scleroderma, General|Scleroderma, Systemic|Thromboembolism|Ventricular Dysfunction, Left
Phase 1: Brain Damage, Chronic|Brain Death|Hyperthyroidism|Intracranial Hypertension|Ischemic Stroke|Neuromyelitis Optica
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2080223235 | P3 |
Completed |
Hypertension, Pulmonary |
2031-11-25 |
|
| BAY63-2521/15681 | P3 |
Unknown Status |
Hypertension, Pulmonary |
2031-01-27 |
|
| PATENT-CHILD | P3 |
Completed |
Hypertension, Pulmonary |
2030-10-07 |
|
| ESRA | P2 |
Active, not recruiting |
Resistant Hypertension|Hypertension, Pulmonary |
2026-09-07 |