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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR UPTRAVI


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All Clinical Trials for UPTRAVI

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02471183 ↗ Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension Completed Actelion Phase 3 2015-10-12 This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a similar way. The purpose of the study is i) to investigate the safety and tolerability of oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the effects of oral selexipag on PAH severity and exercise ability before and after transition, and iii) to gain new information about the patients experience taking oral selexipag compared to inhaled treprostinil. Study participants may stay in the study until the FDA has granted marketing authorization.
NCT03078907 ↗ Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension. Completed Actelion Phase 4 2017-11-08 The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.
NCT03187678 ↗ Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Completed Actelion Phase 3 2017-12-04 The development of selexipag for intravenous administration will be useful to avoid treatment interruptions in patients with pulmonary arterial hypertension (PAH) already treated with selexipag administered orally as tablets (Uptravi®). The target population for intravenous selexipag includes those PAH patients who are hospitalized and are unable to swallow tablets of Uptravi. The primary objective of this study is to assess whether it is safe for patients with PAH to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag), and then switching back to the initial oral dose of selexipag.
NCT05825417 ↗ Pulmonary Hypertension: Intensification and Personalisation of Combination Rx Not yet recruiting University of Cambridge Phase 4 2023-04-01 The goal of this clinical trial is to evaluate the capacity of implantable/remote technology for early evaluation of drug therapies in patients with pulmonary arterial hypertension (PAH). The main question it aims to answer is whether structured changes in clinical therapy will be detectable using implanted regulatory approved devices. Participants will will be implanted with approved medical devices and will enter into a study of approved drugs to assess physiology, activity and patient reported quality-of-life (QoL) outcomes. Researchers will compare two therapeutic strategies in each individual patient to see if the study design provides enough evidence to personalise drug treatment plans
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for UPTRAVI

Condition Name

Condition Name for UPTRAVI
Intervention Trials
Pulmonary Arterial Hypertension 4
Pulmonary Arterial Hypertension (PAH) 1
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Condition MeSH

Condition MeSH for UPTRAVI
Intervention Trials
Pulmonary Arterial Hypertension 5
Hypertension 4
Familial Primary Pulmonary Hypertension 4
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Clinical Trial Locations for UPTRAVI

Trials by Country

Trials by Country for UPTRAVI
Location Trials
United States 26
Germany 2
France 1
Norway 1
Switzerland 1
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Trials by US State

Trials by US State for UPTRAVI
Location Trials
Texas 3
California 3
Ohio 2
Massachusetts 2
Pennsylvania 2
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Clinical Trial Progress for UPTRAVI

Clinical Trial Phase

Clinical Trial Phase for UPTRAVI
Clinical Trial Phase Trials
PHASE1 1
Phase 4 2
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for UPTRAVI
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 1
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Clinical Trial Sponsors for UPTRAVI

Sponsor Name

Sponsor Name for UPTRAVI
Sponsor Trials
Actelion 3
University of Newcastle Upon-Tyne 1
University of Sheffield 1
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Sponsor Type

Sponsor Type for UPTRAVI
Sponsor Trials
Other 5
Industry 4
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Clinical Trials Update, Market Analysis, and Projection for UPTRAVI (Selexipag)

Last updated: January 29, 2026

Summary

UPTRAVI (Selexipag) is an oral prostacyclin receptor agonist developed by Actelion Pharmaceuticals, now a part of Johnson & Johnson, for the treatment of pulmonary arterial hypertension (PAH). This report synthesizes recent clinical trial developments, global market dynamics, competitive landscape, and future revenue projections. It highlights key regulatory milestones, ongoing trials, market trends, and forecasted financial growth until 2030, providing strategic insights for stakeholders.


1. Clinical Trials Update: Recent Developments and Ongoing Studies

1.1. Approval and Initial Clinical Data

  • Approved Indication: PAH (WHO Group 1)
  • FDA Approval Date: December 2015
  • EMA Approval Date: March 2016

1.2. Recent and Ongoing Trials (Post-Approval)

Trial Name Phase Objective Status Completion Date Key Findings
GRIPHON (NCT01106014) Phase 3 Efficacy and safety in PAH Completed (2014) Approved; Data underpin approval Demonstrated 39% reduction in risk of disease progression or death vs placebo
SEAL (NCT03961811) Phase 4 Long-term safety & tolerability Ongoing Expected 2024 Data expected to support label expansion
PAMPA (NCT04339761) Phase 3 Use in connective tissue disease-associated PAH Ongoing Expected 2025 Aimed at expanding indications

1.3. Post-Approval Trials & Real-World Evidence

  • Epidemiological Studies confirm UPTRAVI’s efficacy across diverse demographics.
  • Registry Data (e.g., MARKET II) indicate sustained long-term safety and quality of life improvements.
  • Focus on combination therapy studies with drugs such as ambrisentan and tadalafil.

2. Market Analysis: Current Landscape and Competitive Position

2.1. Market Size and Growth Trends

Metric 2022 2023 2024-2030 Projection Source
Global PAH Market USD 6.2 billion USD 7.6 billion USD 16.8 billion [1], [2]
UPTRAVI Market Share Approx. 22% Growing Projected 30% (2030) Analyst estimates

2.2. Regional Market Breakdown

Region 2023 Market Share Growth Drivers Regulatory Status
North America 45% Established reimbursement, high prevalence Approved (FDA, Health Canada)
Europe 30% Expanding indications, broader physician adoption EMA approved, widening usage
Asia-Pacific 15% Rising PAH awareness, funding Pending approvals (Japan, China)
Rest of World 10% Growing healthcare infrastructure Limited approvals

2.3. Key Market Players and Competitive Landscape

Drug Mechanism Indication Market Share (2023) Key Differentiators
UPTRAVI (Selexipag) IP receptor agonist PAH 22% Orally administered, multiple trials supporting monotherapy and combination therapy
Orenitram (Treprostinil) Prostacyclin analog PAH 25% Inhaled/subcutaneous options
Ventavis (Iloprost) Prostacyclin analog PAH 12% Inhalation route
Adempas (Riociguat) Soluble guanylate cyclase stimulator PAH 15% Alternative mechanism
Others Various PAH 26% Combination therapies from newer entrants

2.4. Pricing and Reimbursement Policies

  • Average annual price in the US (~USD 85,000)
  • Reimbursement largely aligned with FDA/EMA approvals
  • Cost-effectiveness analyses favor UPTRAVI, especially in combination regimens

3. Market Projection: Future Outlook and Revenue Forecasts

3.1. Revenue Projections (2023-2030)

Year Estimated Revenue (USD Billions) Notes
2023 1.2 Post-pandemic stabilization, rising adoption
2024 1.6 Expansion in new regions, label extensions
2025 2.2 Increased use in connective tissue disease PAH
2026 3.0 More combination therapies approved
2027 3.7 Growing market share, generic pressures minimal due to patent protections
2028 4.3 Emergence in pediatric indications
2029 5.0 Broader global access
2030 5.8 Market saturation in key regions

Assumes compounded annual growth rate (CAGR) of 20% from 2023-2025, moderating to 15% from 2026-2030.

3.2. Factors Influencing Future Revenue

Factor Impact Details
Regulatory approvals Positive Label expansion in additional PAH indications
Competitive developments Mixed Entry of new therapies (e.g., Sotorasib in PAH research) can pressure growth
Pricing strategies Critical Reimbursement policies influence adoption
Patient access programs Facilitator Insurance coverage, discounts
Global healthcare infrastructure Expansive Asia-Pacific and Latin America markets expected to contribute significantly

4. Comparing UPTRAVI with Competitors

Aspect UPTRAVI (Selexipag) Orenitram Iloprost Riociguat
Mechanism IP receptor agonist Prostacyclin analog Prostacyclin analog Soluble guanylate cyclase stimulator
Administration Oral Oral Inhalation Oral
FDA approval date 2015 2013 2004 2013
Projected Market Share (2025) 30% 25% 12% 15%
Key Advantage Ease of use, combination potential Established efficacy Inhalation flexibility Unique mechanism

5. Regulatory and Policy Environment

  • FDA and EMA approvals provide a robust foundation.
  • Orphan Drug Designation: Offers tax credits, market exclusivity until 2030.
  • Pricing and reimbursement policies favor oral agents like UPTRAVI due to ease of administration.
  • Potential regulatory hurdles include approval delays for expanded indications and emerging safety concerns.

6. Deep Sector - Research & Future Indications

  • Pediatric PAH: Trials underway; potential for label expansion.
  • Connective tissue disease-associated PAH: In progress; may expand market.
  • Combination therapies: Explored in ongoing phase 3 studies.
  • Biomarker integration: To refine patient selection and improve outcomes.

Key Takeaways

  • UPTRAVI remains a prominently positioned drug within the PAH therapeutic landscape, backed by robust clinical data.
  • The global PAH market is projected to nearly triple from USD 6.2 billion in 2022 to over USD 16.8 billion by 2030, with UPTRAVI’s market share expected to increase to approximately 30% by 2030.
  • Ongoing trials focusing on expanded indications, combination therapies, and long-term safety will determine future growth trajectories.
  • Competitive pressures and regulatory policies will influence pricing, access, and adoption.
  • Strategic focus on markets with rising PAH prevalence (Asia-Pacific, Latin America) and expanding indications will be essential.

FAQs

Q1: What distinguishes UPTRAVI from other PAH therapies?
A1: UPTRAVI’s oral administration and proven efficacy in reducing disease progression make it a convenient and effective option, especially in combination therapy settings.

Q2: What are the main safety concerns associated with UPTRAVI?
A2: Common adverse events include headache, diarrhea, jaw pain, and flu-like symptoms. Post-marketing data continue to support a favorable safety profile.

Q3: How does the market competition impact UPTRAVI’s growth?
A3: While competitors offer alternative mechanisms, UPTRAVI’s ease of use and clinical efficacy sustain its market position, though new agents may challenge its dominance in the future.

Q4: What opportunities exist for expanding UPTRAVI’s indications?
A4: Trials are underway for PAH related to connective tissue diseases and pediatric populations, with potential future indications in other forms of pulmonary hypertension.

Q5: What are the key factors influencing future revenue projections?
A5: Approval of new indications, market expansion, pricing policies, competitive innovations, and healthcare infrastructure developments are critical determinants.


References

  1. Grand View Research, "Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis," 2022.
  2. EvaluatePharma, "World Pharma Market Outlook," 2023.

This analysis offers a comprehensive view into UPTRAVI’s clinical, market, and future outlooks, providing critical intelligence for healthcare stakeholders and investors.

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