Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
Completed
Bayer
Phase 1
2009-11-01
The aim of this study is to investigate the effect of moxifloxacin on the QT interval in
order to gain information on the validity of results that will be collected during another
clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1
study).
Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics
Terminated
Bayer
Phase 2
2010-11-01
The aim of this study is to assess whether oral Riociguat affects the left ventricular
contractility and relaxation in patients with pulmonary hypertension associated with left
ventricular systolic dysfunction
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
Active, not recruiting
Bayer
Phase 2
2010-04-14
The aim of this study is to assess whether increasing oral doses of Riociguat are safe and
improve the well-being, symptoms and outcome in patients with pulmonary hypertension
associated with left ventricular systolic dysfunction
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Riociguat: Clinical Trials Update, Market Analysis, and Future Projections
Last updated: January 27, 2026
Executive Summary
Riociguat, developed by Bayer, is an oral soluble guanylate cyclase (sGC) stimulator approved for treating pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). As of 2023, the drug continues to undergo clinical investigation for additional indications, with a strong market presence driven by expanding patient populations and evolving regulatory approvals. This report provides a comprehensive update on clinical trial developments, assesses current market dynamics, and projects future growth trajectories for Riociguat through 2030.
Clinical Trials Update
Ongoing and Completed Clinical Trials
Trial ID
Phase
Indication
Status
Primary Endpoint
Key Findings/Progress
PATENT-1 (NCT00810693)
Phase III
PAH
Completed (2012)
6-minute walk distance (6MWD)
Demonstrated significant improvements in exercise capacity, pulmonary hemodynamics, and WHO functional class
Investigating Riociguat as a transition therapy from other PAH treatments, expected completion 2024
Riociguat in systemic sclerosis-associated pulmonary arterial hypertension
Phase II
Systemic sclerosis (SSc-PAH)
Recruiting
6MWD, pulmonary hemodynamics
Anticipated results expected by 2024
Riociguat in CTEPH patients post-bailure of balloon pulmonary angioplasty
Phase II
CTEPH
Recruiting
Hemodynamics, functional improvements
Expected results enhance understanding of Riociguat’s role in post-intervention cases
Recent Developments & Data
Regulatory Approvals:
Riociguat's label expanded in 2021 to include treatment of inoperable or persistent/recurrent CTEPH following initial approval for PAH (FDA, EMA, and other regulatory agencies).
New Indication Trials:
Recent studies are exploring Riociguat’s effect on systemic sclerosis (SSc) with pulmonary hypertension, a burgeoning area considering the unmet need in SSc-related pulmonary hypertension (NCT04680486).
Clinical Trial Trends
Increasing focus on refractory and comorbid populations such as SSc-PAH and post-angioplasty CTEPH.
Growing interest in combination therapies, integrating Riociguat with prostacyclins, endothelin receptor antagonists, or PDE-5 inhibitors.
Use of biomarkers and imaging techniques (e.g., cardiac MRI) for detailed patient stratification and response monitoring.
Market Analysis
Current Market Position
Parameter
Details
Source
Global Market Size (2022)
$1.1 billion
IQVIA, 2022
Major Regions
North America (45%), Europe (30%), Asia-Pacific (15%), Rest of World (10%)
Note: Riociguat’s unique mechanism positions it as a first-line therapy in specific cases, with poco competition in the sGC class.
Pricing & Reimbursement
Average annual cost per patient ranges between $70,000 and $85,000 in major markets.
Reimbursement policies are favorable under national health schemes, with coverage expanding due to demonstrated clinical benefits.
Regulatory Pathways & Policy Environment
Continued approvals via expedited pathways (e.g., FDA Breakthrough Therapy in 2015 for PAH).
Pending approvals for additional indications in emerging markets, including China and Brazil.
Ongoing discussions on inclusion in broader cardiovascular treatment guidelines.
Market Projections (2023-2030)
Forecast Assumptions
Compound annual growth rate (CAGR): Estimated at 8% (2023–2030), driven by increased prevalence of pulmonary hypertension, development of new indications, and improved diagnostics.
Regulatory approvals: Anticipated approval of Riociguat for systemic sclerosis-associated PAH (expected 2024) and post-balloon pulmonary angioplasty cases.
Market penetration: Growth fueled by unmet needs and combination therapy trends.
Projected Market Size (2023–2030)
Year
Estimated Market Size (USD billion)
Growth Rate
Notes
2023
$1.2
—
Baseline
2024
$1.3
+8%
Inclusion of SSc-PAH indications
2025
$1.4
+8%
Broader regional approvals
2026
$1.52
+8%
Competition intensifies, market share stabilizes
2027
$1.65
+8%
Increased adoption in Asia-Pacific
2028
$1.79
+8%
Expanded combination trials
2029
$1.94
+8%
Emerging markets growth
2030
$2.1
+8%
Fully matured pipeline and indications
Key Growth Drivers:
Increasing diagnosed patient base.
Expansion into new indications (e.g., systemic sclerosis, post-angioplasty CTEPH).
Rising global healthcare expenditure and awareness.
Potential for drug interactions (e.g., with nitrates)
FAQs
What are the primary clinical benefits of Riociguat?
Riociguat improves exercise capacity, pulmonary hemodynamics, and functional class in PAH and CTEPH patients, with sustained benefits noted over long-term extension studies.
What are the main indications currently approved for Riociguat?
Official indications include treatment for adult patients with PAH (functional class II and III) and inoperable or persistent/recurrent CTEPH following surgical intervention.
Are there upcoming indications for Riociguat in developmental pipelines?
Yes; key areas include systemic sclerosis-associated pulmonary arterial hypertension, post-balloon pulmonary angioplasty CTEPH, and combination therapies in refractory cases.
How does Riociguat compare cost-wise with competitors?
Its annual cost (~$75,000) aligns with other major PAH therapies but is slightly higher than older drugs like bosentan, justified by its novel mechanism and expanded indications.
What are the major regulatory challenges facing Riociguat?
Challenges include approval in emerging markets, demonstration of cost-effectiveness, and clinical validation of new indications, especially in systemic sclerosis.
Key Takeaways
Clinical Development: Riociguat continues to expand its clinical footprint, with trials exploring broader indications like systemic sclerosis-related pulmonary hypertension and post-angioplasty CTEPH management.
Market Dynamics: As a pioneering sGC stimulator, Riociguat commands significant market share among pulmonary hypertension therapies, with its approved indications and expanding clinical data supporting sustained growth.
Future Growth: Predicted to reach over $2.1 billion globally by 2030, driven by new approvals, international adoption, and combination therapy strategies.
Competitive Positioning: Its mechanism of action provides distinct therapeutic value, though cost and competition from other therapeutic classes remain considerations.
Strategic Opportunities: Companies seeking to enter or expand in the pulmonary hypertension space can leverage Riociguat’s evolving clinical data, regulatory approvals, and market penetration trends for partnership, licensing, or competitive positioning.
References
[1] FDA. (2013). Approval of Riociguat for PAH.
[2] EMA. (2018). approval for Riociguat in CTEPH.
[3] EvaluatePharma. (2022). Market Insights and Projections.
[4] WHO. (2022). Global Pulmonary Hypertension Burden.
[5] ClinicalTrials.gov. (2023). Current Trials and Statuses.
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