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Last Updated: May 20, 2025

CLINICAL TRIALS PROFILE FOR OPSUMIT


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All Clinical Trials for Opsumit

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02050802 ↗ Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects Completed Actelion Phase 1 2011-08-01 The study is intended to demonstrate that macitentan does not have an effect on cardiac repolarization exceeding the threshold of regulatory concern after repeated administration of daily oral doses of 10 and 30 mg to healthy male and female subjects.
NCT02126943 ↗ OPsumit USers Registry Completed Actelion 2014-04-30 Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.
NCT02476864 ↗ Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults Completed Actelion Phase 1 2015-08-01 A study conducted in healthy adults to investigate if a new macitentan tablet leads to the same fate of macitentan in the body (time of onset, time of presence, amount in the blood) as the marketed macitentan tablet.
NCT02651272 ↗ Macitentan in Pulmonary Hypertension of Sickle Cell Disease Terminated Actelion Phase 2 2015-07-01 This is a pilot study to assess the safety and efficacy of macitentan in patients with pulmonary hypertension of sickle cell disease. This study will enroll approximately 10 subjects. Study participation for each subject will last approximately 24 weeks from screening to end of treatment follow-up.
NCT02651272 ↗ Macitentan in Pulmonary Hypertension of Sickle Cell Disease Terminated Boston University Phase 2 2015-07-01 This is a pilot study to assess the safety and efficacy of macitentan in patients with pulmonary hypertension of sickle cell disease. This study will enroll approximately 10 subjects. Study participation for each subject will last approximately 24 weeks from screening to end of treatment follow-up.
NCT02885012 ↗ Crossover Study From Macitentan or Bosentan Over to Ambrisentan Terminated Ochsner Health System Phase 4 2016-06-01 The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Opsumit

Condition Name

Condition Name for Opsumit
Intervention Trials
Healthy 7
Pulmonary Arterial Hypertension 3
Healthy Subjects 2
Lung Transplant Rejection 1
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Condition MeSH

Condition MeSH for Opsumit
Intervention Trials
Hypertension 5
Pulmonary Arterial Hypertension 3
Familial Primary Pulmonary Hypertension 3
Hypertension, Pulmonary 2
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Clinical Trial Locations for Opsumit

Trials by Country

Trials by Country for Opsumit
Location Trials
United States 65
Belgium 4
Germany 3
Japan 2
Canada 2
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Trials by US State

Trials by US State for Opsumit
Location Trials
California 4
Massachusetts 3
Arizona 3
Minnesota 2
Maryland 2
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Clinical Trial Progress for Opsumit

Clinical Trial Phase

Clinical Trial Phase for Opsumit
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Opsumit
Clinical Trial Phase Trials
Completed 6
Recruiting 4
Not yet recruiting 4
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Clinical Trial Sponsors for Opsumit

Sponsor Name

Sponsor Name for Opsumit
Sponsor Trials
Actelion 11
University of California, Los Angeles 2
Janssen Research & Development, LLC 2
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Sponsor Type

Sponsor Type for Opsumit
Sponsor Trials
Industry 15
Other 7
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Opsumit (Macitentan): Clinical Trials, Market Analysis, and Projections

Introduction

Opsumit, also known as macitentan, is a next-generation endothelin receptor antagonist (ERA) developed by Actelion and now marketed by Johnson & Johnson. It has been a significant player in the treatment of pulmonary arterial hypertension (PAH) since its approval in 2013. Here, we delve into the clinical trials, market analysis, and future projections for Opsumit.

Clinical Trials: SERAPHIN and Beyond

SERAPHIN Trial

The SERAPHIN trial was a landmark study that evaluated the efficacy and safety of Opsumit in patients with PAH. This large, event-driven, multicenter, long-term trial involved 742 patients and demonstrated that Opsumit significantly reduced the risk of disease progression by 45% compared to placebo. The primary endpoint included time to the first occurrence of death, significant morbidity events, or clinical worsening of PAH. The trial showed that Opsumit reduced clinical worsening events and PAH-related hospitalizations by 50%[1].

Key Findings from SERAPHIN

  • Disease Progression: Opsumit reduced the risk of disease progression by 45% vs. placebo.
  • Clinical Worsening: The drug significantly reduced clinical worsening events, including a sustained ≥15% decrease from baseline in 6-minute walking distance (6MWD), worsening of PAH symptoms, and the need for additional PAH treatment.
  • PAH-Related Hospitalization: Opsumit reduced the risk of PAH-related hospitalization by 50%[1].

Ongoing and Completed Trials

UNISUS Study

The UNISUS study is an ongoing trial comparing the effectiveness and safety of a higher dose (75 mg) of Opsumit to the standard dose (10 mg) in patients with PAH. This study aims to provide more information about the investigational medication’s effectiveness and safety at the higher dose[4].

MACiTEPH Trial

Johnson & Johnson recently halted the MACiTEPH trial, which was investigating the use of a higher dose of Opsumit (75 mg) for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). The trial was stopped after an interim analysis indicated that it would not meet its primary endpoints[3].

Market Analysis

Market Leadership

Opsumit has established itself as a market leader in the PAH treatment market. It has consistently demonstrated strong sales performance, achieving blockbuster sales of $1,639 million in 2020. This success has been driven by its efficacy in delaying disease progression and improving patient outcomes[5].

Sales Performance

Since its approval, Opsumit has shown rapid growth. In the first quarter of 2015, it generated $99.5 million in sales, which increased to $390.2 million in the first half of 2016. By the end of June 2015, Opsumit had generated sales of 208 million Swiss francs, benefiting over 9,800 patients[5].

Competitive Landscape

Opsumit faces competition from other drug classes, including phosphodiesterase type 5 inhibitors (PDE5 inhibitors) and prostanoids. However, its strong patent portfolio and demonstrated efficacy have helped maintain its market position. The drug does not share the same black box warning for hepatotoxicity as its predecessor, Tracleer (bosentan), which is another advantage[2].

Projections and Future Outlook

Market Growth Drivers

The PAH market is expected to continue growing, driven by label expansions into non-PAH subtypes and positive data on morbidity/mortality endpoints. Opsumit is anticipated to play a crucial role in this growth, particularly as clinical trials support its use in broader patient populations[5].

Forecasted Sales

Opsumit is forecasted to achieve peak sales of $2.2 billion in 2025 across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK). This projection is based on its current market performance and the potential for label expansions, including approval for CTEPH and pediatric PAH[2].

Pipeline and Innovation

Johnson & Johnson's innovative medicine division, which includes Opsumit, is poised for robust growth. The company expects to deliver a compound annual growth rate (CAGR) of 5-7% from 2025 to 2030, driven by market share gains, new product launches, and expansions into new patient populations[5].

Key Takeaways

  • Clinical Efficacy: Opsumit has demonstrated significant reductions in disease progression and PAH-related hospitalizations in the SERAPHIN trial.
  • Market Leadership: Opsumit is the established market leader in the PAH treatment market, with strong sales performance.
  • Future Outlook: The drug is expected to continue growing, driven by potential label expansions and positive clinical data.
  • Competitive Advantage: Opsumit’s strong patent portfolio and lack of a black box warning for hepatotoxicity maintain its competitive edge.

FAQs

What is Opsumit used for?

Opsumit (macitentan) is used for the treatment of pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs.

What were the key findings of the SERAPHIN trial?

The SERAPHIN trial showed that Opsumit reduced the risk of disease progression by 45% and PAH-related hospitalization by 50% compared to placebo.

Why was the MACiTEPH trial halted?

The MACiTEPH trial was halted after an interim analysis indicated that the higher dose of Opsumit (75 mg) would not meet its primary endpoints for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH).

What are the future sales projections for Opsumit?

Opsumit is forecasted to achieve peak sales of $2.2 billion in 2025 across several major markets.

Is Opsumit being investigated for other indications?

Yes, Opsumit is being investigated for potential label expansions, including chronic thromboembolic pulmonary hypertension (CTEPH) and pediatric PAH.

Sources

  1. OPSUMIT® (macitentan) HCP: SERAPHIN Trial.
  2. Opsumit Drug Profile 2016-2025: Research and Markets.
  3. J&J dumps Opsumit trial upon pulmonary hypertension flop: FiercePharma.
  4. Opsumit Medication | Pulmonary Hypertension | Clinical Trial: National Jewish Health.
  5. OPSUMIT Drug Patent Profile: Drug Patent Watch.
Last updated: 2025-01-01

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