Drug updated on 4/24/2024

Dosage FormTablet (oral; 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg)
Drug ClassSoluble guanylate cyclase (sGC) stimulators
Ongoing and
Completed Studies


  • 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.
  • For the treatment of adults with Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class, and to delay clinical worsening.

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  • Riociguat (Adempas) is indicated for the treatment of adults with persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH), to improve exercise capacity, WHO functional class, and delay clinical worsening.
  • Eleven studies were reviewed, focusing on various aspects of riociguat's efficacy in treating PAH and CTEPH, including comparisons with other medications, detailed outcome analyses, and subgroup considerations.
  • Compared to conventional therapies such as phosphodiesterase type 5 inhibitors (PDE-5is), endothelin receptor antagonists (ERAs), selexipag, etc., riociguat significantly improved parameters like the 6-minute walk distance, mean pulmonary arterial pressure, among others, without significantly increasing side effects.
  • The safety profile of riociguat was found to be comparable to other PAH-targeted therapies; common side effects included dyspepsia and peripheral edema but did not increase adverse events compared to control interventions.
  • Subgroup analysis showed that riociguat benefits various subgroups, including patients with specific connective tissue disease-associated PAH, although its impact on survival rates was unclear or not significantly different from controls.
  • Special consideration should be given when comparing Balloon Pulmonary Angioplasty for inoperable CTEPH, where BPA might provide greater improvements except for cardiac output, though riociguat offers a well-tolerated oral option.
  • Riociguat displayed similar or slightly superior efficacy against Selexipag while offering cost-saving benefits, making it valuable in PAH management strategies.
  • Special attention should be given to patients unresponsive to traditional treatments or those having comorbidities like systemic sclerosis, where indications suggest that riociguat can potentially delay disease progression among these patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Adempas (riociguat) Prescribing Information.2023Bayer HealthCare Pharmaceuticals Inc.,Whippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Treatment of pulmonary arterial hypertension in patients with connective tissue diseases: a systematic review and meta-analysis.2024Internal and Emergency Medicine
Efficacy and safety of riociguat replacing PDE-5is for patients with pulmonary arterial hypertension: a systematic review and meta-analysis.2023Frontiers in Pharmacology
Indirect treatment comparison and cost-minimization analysis of riociguat versus selexipag in patients with pulmonary arterial hypertension.2022Expert review of Pharmaeconomics & Outcomes research
Comparative Efficacy and Safety of Targeted Therapies for Chronic Thromboembolic Pulmonary Hypertension: A Systematic Review and Network Meta-Analysis.2022Canadian Respiratory Journal
Medications for the treatment of pulmonary arterial hypertension: a systematic review and network meta-analysis.2022European Respiratory Review
Efficacy and safety of riociguat in the treatment of chronic thromboembolic pulmonary arterial hypertension: a meta-analysis.2021Medicine
Riociguat therapy for pulmonary hypertension: a systematic review and meta-analysis.2021Annals of Palliative Medicine
Safety and efficacy of soluble guanylate cyclase stimulators in patients with heart failure: a systematic review and meta-analysis. 2020World Journal of Cardiology
Efficacy and safety of the use of pulmonary arterial hypertension pharmacotherapy in patients with pulmonary hypertension secondary to left heart disease: a systematic review.2019Pharmacotherapy
Balloon pulmonary angioplasty vs riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension: a systematic review and meta-analysis.2019Clinical Cardiology
Influence of riociguat treatment on pulmonary arterial hypertension : A meta-analysis of randomized controlled trials.2019Herz

Clinical Practice Guidelines