CLINICAL TRIALS PROFILE FOR ADEMPAS

All Clinical Trials for ADEMPAS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02024386 ↗	Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude	Completed	Richard Moon	Phase 4	2014-01-01	During ascent to high altitude there is a physiologic response to hypoxia that results in an elevated pulmonary arterial pressure associated with decreased exercise performance, altitude-induced pulmonary hypertension, and high altitude pulmonary edema (HAPE). Riociguat is a novel agent from Bayer Pharmaceuticals that has already demonstrated effectiveness in the treatment of pulmonary hypertension, and it may prove to be beneficial in cases of altitude-induced pulmonary hypertension or HAPE. This research study, composed of 20 healthy volunteers ages 18-40 years, will attempt to mimic the decreased oxygen supply and elevated pulmonary artery pressures found in conditions of high altitude, allowing observation of the effects of riociguat and exercise on pulmonary arterial pressure, arterial oxygenation, and exercise performance. Prior to entering the hypobaric chamber, subjects will have radial arterial lines and pulmonary artery catheters placed to obtain arterial and pulmonary artery pressure measurements. Subjects will then enter the hypobaric chamber and perform exercise tolerance tests at a simulated altitude of 15,000 feet on an electrically braked ergometer (exercise bike) before and after administration of riociguat. If, after administration of riociguat and exposure to a simulated altitude of 15,000 feet, the exercise performance is improved and observed pulmonary artery pressures are lower than those measurements seen prior to administration of riociguat, this could lead to development of a prophylactic and/or treatment strategy for HAPE and high-altitude pulmonary hypertension. Statistical analysis will compare the variables of pulmonary artery pressure, radial arterial pressure, ventilation rate, cardiac output, PaO2, and work rate at exhaustion before and after administration of the drug riociguat. The investigator's hypothesis is that riociguat will decrease pulmonary artery pressure and improve gas exchange and exercise performance at altitude.
NCT02092818 ↗	EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension	Completed	Bayer		2014-05-31	In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.
NCT02159326 ↗	Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women	Completed	Bayer	Phase 1	2014-06-01	Physicians might be concerned that Adempas may have a metabolic interaction with oral contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information regarding lack of potential pharmacokinetic interaction has been communicated; there is a need for more re-assurance and further data that there is no interaction between Adempas and OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered adequate to inform about safe use of Adempas with OCs.

Clinical Trial Conditions for ADEMPAS

Condition Name

Condition Name for ADEMPAS
Intervention	Trials
Hypertension, Pulmonary	5
Pulmonary Arterial Hypertension	3
Chronic Thromboembolic Pulmonary Hypertension	2

Condition MeSH

Condition MeSH for ADEMPAS
Intervention	Trials
Hypertension	7
Hypertension, Pulmonary	7
Pulmonary Arterial Hypertension	5

Clinical Trial Locations for ADEMPAS

Trials by Country

Trials by Country for ADEMPAS
Location	Trials
United States	27
Germany	3
France	2
Austria	2
United Kingdom	2

Trials by US State

Trials by US State for ADEMPAS
Location	Trials
North Carolina	3
Pennsylvania	2
New York	2
District of Columbia	2
California	2

Clinical Trial Progress for ADEMPAS

Clinical Trial Phase

Clinical Trial Phase for ADEMPAS
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	6

Clinical Trial Status

Clinical Trial Status for ADEMPAS
Clinical Trial Phase	Trials
Completed	8
Recruiting	6
Not yet recruiting	3

Clinical Trial Sponsors for ADEMPAS

Sponsor Name

Sponsor Name for ADEMPAS
Sponsor	Trials
Bayer	6
Actelion	2
Medical University of Vienna	2

Sponsor Type

Sponsor Type for ADEMPAS
Sponsor	Trials
Other	17
Industry	9

Clinical Trials Update, Market Analysis and Projection for Adempas

Last updated: October 28, 2025

Introduction

Adempas (riociguat) is a prescription medication developed by Bayer AG, primarily indicated for the treatment of pulmonary hypertension (PH), including chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH). Approved by the FDA in 2013, Adempas has become an important agent in its therapeutic niche, supported by ongoing clinical research, evolving market dynamics, and expanding indications. This article provides a comprehensive update on Adempas's clinical trials, analyzes current market conditions, and forecasts future growth trajectories.

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Clinical Trials Update

Ongoing Clinical Research and New Trials

Since its initial approval, Adempas has been the subject of multiple clinical trials aimed at broadening its application scope, optimizing dosing strategies, and evaluating long-term safety profiles.

• PAH and CTEPH Expansion: Bayer has continued to explore Adempas’s efficacy in different subpopulations of pulmonary hypertension. Notably, trials such as the CHEST-1 and CHEST-2 studies demonstrated significant benefits in CTEPH patients, with subsequent studies reaffirming these findings. Recent trials focus on combination therapies, assessing Adempas alongside endothelin receptor antagonists and phosphodiesterase-5 inhibitors to enhance therapeutic outcomes.

• Long-term Safety and Efficacy Studies: A pivotal Phase IV trial, initiated in 2021, tracks long-term safety and quality-of-life outcomes over multiple years. Early published data suggest sustained improvements in exercise capacity (6-minute walk distance) and functional class, with a manageable safety profile consistent with previous studies.

• Potential New Indications:

  • Cystic Fibrosis-associated Pulmonary Hypertension: An exploratory phase II trial (NCT04393809) investigates Adempas as an adjunct in cystic fibrosis patients with PH, based on preclinical evidence showing vasodilatory effects.
  • Lung Vascular Disease in Connective Tissue Disorders: Bayer is evaluating Adempas's utility in pulmonary hypertension related to systemic sclerosis, currently in early-phase trials.

Key Clinical Trial Milestones

• FDA Post-Approval Studies: Bayer completed the REPLACE trial (NCT02812008) assessing the safety and efficacy of switching patients from other PAH therapies to Adempas, with positive outcomes supporting its interchangeability in clinical practice.

• Registrational and Real-World Evidence: Multiple registries are accumulating real-world data, indicating that Adempas remains effective in diverse populations. These suggest an overall safety profile consistent with clinical trials, with adverse events largely limited to hypotension and headache.

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Market Analysis

Current Market Landscape

The global pulmonary hypertension drug market was valued at approximately USD 4.2 billion in 2022 and is projected to grow modestly at a CAGR of around 4-5% through 2030, driven by increasing diagnosis rates and expanding indications. Adempas holds a significant niche, competing with agents such as bosentan, ambrisentan, and selexipag.

• Market Share: In 2022, Adempas captured roughly 12-15% of the pulmonary hypertension drug market, primarily in the United States and Europe. Its share is driven by its unique mechanism of action—soluble guanylate cyclase stimulator—and positive clinical trial data.

• Pricing and Reimbursement: The average wholesale price (AWP) for Adempas is approximately USD 14,000 per month. Reimbursement is generally favorable in developed markets, although price pressure from biosimilars and generics in related spaces may influence future pricing strategies.

• Distribution Channels: While hospital outpatient clinics and specialty pharmacies are primary channels, Bayer's direct sales force actively promotes Adempas to pulmonologists and cardiologists.

Market Drivers and Barriers

• Drivers:

  • Increasing prevalence of pulmonary hypertension, especially in patients with connective tissue disorders, congenital heart defects, and post-PE (pulmonary embolism) CTEPH.
  • Expanding clinical evidence supporting early intervention and combination therapy approaches.
  • Growing awareness among clinicians regarding the benefits of targeting the NO-sGC pathway with Adempas.

• Barriers:

  • High treatment costs and complex reimbursement processes.
  • Safety concerns, especially related to hypotension and bleeding risks in vulnerable populations.
  • Competition from other therapies with longer market presence and established efficacy.

Regional Market Analysis

• North America: Dominates due to established diagnostic infrastructure, reimbursement coverage, and high disease awareness.
• Europe: Significant growth driven by improved diagnosis and approval in multiple countries.
• Asia-Pacific: Opportunities are emerging, with increased focus on pulmonary hypertension associated with connective tissue diseases, though regulatory and cost barriers remain.

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Market Projection

Future Growth Trajectory

Based on current clinical developments, market trends, and Bayer's ongoing commercialization strategies, Adempas's market is projected to experience steady growth over the next decade:

• Market Penetration: Intensity of use is expected to increase as clinical trial data solidify Adempas's role in combination therapy and new indications.
• Revenue Forecasts: The global sales of Adempas are projected to reach USD 1.2 billion by 2030, representing a CAGR of approximately 8% from 2023 levels, driven by increased adoption and expanded labeling.

Emerging Opportunities and Risks

• Opportunities:

  • Broader use in CTEPH patients, including those who are inoperable or residual post-surgical cases.
  • Label expansion into pediatric populations, supported by ongoing safety evaluations.
  • Potential approval in new indications, including pulmonary hypertension in systemic sclerosis and cystic fibrosis.

• Risks:

  • Competitive pressure from newer agents and generic formulations.
  • Regulatory hurdles in developing markets and for additional indications.
  • Efficacy thresholds not met in future trials or emergent safety concerns.

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Conclusion

Adempas remains a pivotal therapy within the pulmonary hypertension landscape, underpinned by a robust pipeline of clinical trials aimed at expanding its application and solidifying its efficacy profile. The current market outlook is optimistic, with projections indicating sustained growth fueled by growing disease prevalence, favorable clinical evidence, and strategic expansion into new markets and indications.

Key Takeaways

• Clinical credibility: Ongoing studies support Adempas's long-term safety and efficacy in PAH and CTEPH, with potential emerges in related vascular diseases.
• Market positioning: Adempas holds a significant share in a specialized, yet growing pulmonary hypertension segment, backed by positive clinical outcomes.
• Growth prospects: Revenue is projected to grow at a CAGR of approximately 8% through 2030, driven by increasing diagnoses, expanded indications, and combination therapy adoption.
• Competitive landscape: Bayer’s strategic focus on clinical innovation and market expansion positions Adempas favorably despite competitive and regulatory challenges.
• Future opportunities: Label expansion, real-world evidence accumulation, and emerging indications are key to maximizing Adempas's market potential.

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FAQs

1. What are the primary indications for Adempas?
   Adempas is approved for pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), including role in patients unsuitable for surgical interventions.

2. Are there ongoing clinical trials investigating new indications for Adempas?
   Yes. Bayer is exploring its use in cystic fibrosis-associated PH, systemic sclerosis-related PH, and as part of combination therapies to enhance efficacy.

3. What are the key safety concerns associated with Adempas?
   The main safety considerations include hypotension, bleeding risks, and contraindications during pregnancy. Long-term safety data remain favorable but are closely monitored.

4. How does Adempas compare to other pulmonary hypertension therapies?
   It offers a unique mechanism as an sGC stimulator, often used in combination therapy. Its efficacy compares favorably, but cost and safety profile influence clinical choice.

5. What is the outlook for Adempas's market growth?
   The drug is projected to see moderate but sustained growth, reaching approximately USD 1.2 billion in global sales by 2030, supported by expanding indications and clinical evidence.

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References

1. Bayer AG. Adempas (riociguat) Summary of Product Characteristics. 2022.
2. MarketsandMarkets. Pulmonary Hypertension Drugs Market Report. 2022.
3. Bayer AG. Clinical Trial Registry. 2023.
4. FDA Drug Approvals Database. 2013.
5. GlobalData. Pulmonary Hypertension Market Analysis. 2022.