CLINICAL TRIALS PROFILE FOR SELEXIPAG

All Clinical Trials for SELEXIPAG

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01106014 ↗	Selexipag (ACT-293987) in Pulmonary Arterial Hypertension	Completed	Actelion	Phase 3	2009-12-01	The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.
NCT02206204 ↗	Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects	Completed	Actelion	Phase 1	2012-06-01	This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy male and female subjects. The primary objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects. Moxifloxacin is included as a positive control.
NCT02206295 ↗	Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg	Completed	Actelion	Phase 1	2012-09-01	The primary aim of this study is to demonstrate bioequivalence in the rate and extent of absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of 1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8 film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects following a multiple-dose up-titration scheme.
NCT02260557 ↗	Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis	Completed	Actelion	Phase 2	2014-10-01	The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).
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.
NCT02558231 ↗	The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension	Completed	Actelion	Phase 3	2016-05-01	The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.
NCT02745860 ↗	Comparison of Two Dose Strengths of Selexipag in Healthy Adults	Completed	Actelion	Phase 1	2016-06-01	Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.

Clinical Trial Conditions for SELEXIPAG

Condition Name

Condition Name for SELEXIPAG
Intervention	Trials
Pulmonary Arterial Hypertension	8
Healthy Subjects	5
Hypertension, Pulmonary	3
Pharmacokinetics	1

Condition MeSH

Condition MeSH for SELEXIPAG
Intervention	Trials
Hypertension	13
Pulmonary Arterial Hypertension	11
Familial Primary Pulmonary Hypertension	8
Hypertension, Pulmonary	6

Clinical Trial Locations for SELEXIPAG

Trials by Country

Trials by Country for SELEXIPAG
Location	Trials
United States	128
Canada	20
Germany	12
France	11
United Kingdom	8

Trials by US State

Trials by US State for SELEXIPAG
Location	Trials
Texas	9
California	9
Ohio	8
Pennsylvania	7
North Carolina	6

Clinical Trial Progress for SELEXIPAG

Clinical Trial Phase

Clinical Trial Phase for SELEXIPAG
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	3
Phase 3	8

Clinical Trial Status

Clinical Trial Status for SELEXIPAG
Clinical Trial Phase	Trials
Completed	15
Recruiting	7
Not yet recruiting	2

Clinical Trial Sponsors for SELEXIPAG

Sponsor Name

Sponsor Name for SELEXIPAG
Sponsor	Trials
Actelion	21
University of Cambridge	1
University of Glasgow	1

Sponsor Type

Sponsor Type for SELEXIPAG
Sponsor	Trials
Industry	24
Other	6

Selexipag: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 20, 2026

What is the current status of Selexipag in clinical trials?

Selexipag remains approved for the treatment of pulmonary arterial hypertension (PAH). The drug was approved by the U.S. Food and Drug Administration (FDA) in December 2015 and by the European Medicines Agency (EMA) in August 2015. Since approval, no new pivotal Phase III trials specifically for Selexipag have been announced. However, ongoing real-world evidence collection and post-marketing surveillance continue to monitor its safety and efficacy profile.

Relevant clinical trial phases:

• Completed Trials: Several Phase III trials, including the GRIPHON study (NCT01106058), demonstrated efficacy and safety over long-term use. The GRIPHON trial enrolled 1,156 patients and was finalized in 2014, serving as the pivotal trial for regulatory approval.

• Ongoing Studies: Limited active trials focus on drug combinations, pediatric use, and expanded indications beyond PAH. No major Phase III trials are currently in recruitment or active phases centered solely on monotherapy.

• Post-Market Surveillance: Data from registries and observational studies continue to evaluate off-label uses and long-term safety.

What is the market size and growth outlook for Selexipag?

The pulmonary arterial hypertension (PAH) market, valued at approximately USD 3.2 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 8-10% through 2030. Selexipag accounts for roughly 25-30% of this market, depending on regional drug adoption rates.

Market segmentation:

Region	Market Share (%)	Estimated Sales (USD, 2022)	Growth Drivers
North America	35	0.8 billion	High prevalence, strong reimbursement pathways
Europe	25	0.7 billion	Expanding diagnosis, increasing off-label use
Asia-Pacific	20	0.5 billion	Growing awareness, increased diagnosis
Rest of World	20	0.2 billion	Emerging markets, limited access

Key growth drivers include increased diagnosis rates, expanding treatment guidelines, and a rising prevalence of PAH linked to congenital heart disease and connective tissue disorders.

How is Selexipag positioned against competitors?

The main competitors include:

• Epoprostenol (Flolan): Intravenous prostacyclin analog, highly effective but invasive, with complex administration.
• Macitentan (Opsumit): Endothelin receptor antagonist; oral administration and well-established.
• Ambrisentan and Bosentan: Other endothelin receptor antagonists.

Selexipag offers oral dosing with a favorable safety profile, positioning it as a preferred option for maintenance therapy. However, its market penetration faces limitations due to competition from combination therapies and newer agents.

What are the projected trends for Selexipag's market penetration?

By 2030, Selexipag's market share is expected to stabilize or slightly decline owing to the entry of combination therapies and new drug approvals. The following factors influence growth:

• Combination therapy adoption: Evidence supports combining Selexipag with endothelin receptor antagonists or phosphodiesterase-5 inhibitors.
• Extended indications: Trials exploring pediatric and broader PAH populations could enhance sales.
• Regional growth: Greater penetration into Asia-Pacific and Latin America markets.

Estimated annual sales forecast:

Year	Estimated USD (Billion)	Notes
2023	0.9	Steady growth, initial expansion in emerging markets
2025	1.2	Adoption of combination therapies gains traction
2030	1.5	Market maturity, competition influence

Key regulatory and development updates

• Regulatory approvals have not been challenged or rescinded for Selexipag since approval.
• New trials focus on combination regimens with sGC stimulators and ERA agents.
• Label updates include increased guidance on dose titration and management of adverse effects like headache and jaw pain.

Summary table: Clinical trial landscape and market overview

Aspect	Details
Key clinical trial	GRIPHON (NCT01106058), completed 2014
Market size (2022)	USD 3.2 billion for PAH
Market share	Selexipag accounts for approximately 25-30%
Market growth	8-10% CAGR projected, 2022–2030
Main competitors	Epoprostenol, macitentan, ambrisentan, bosentan

What are the key challenges impacting Selexipag’s future?

• Competition from combination therapies and therapies addressing other PAH pathways.
• Limited expansion into new PAH populations, requiring further trials.
• Price pressures and reimbursement constraints in emerging markets.
• Long-term safety and adherence concerns in real-world use.

Key Takeaways

• Selexipag’s clinical trial landscape remains stable following its 2015 approval, with no new pivotal trials announced.
• The drug holds a significant market share within the growing PAH therapeutics market, primarily driven by North American and European adoption.
• Growth prospects rely heavily on expanding indication and combination therapy adoption, with projected sales reaching USD 1.5 billion by 2030.
• Competition and reimbursement dynamics will influence its market position.

FAQs

1. Are there ongoing trials exploring Selexipag for indications beyond PAH?
No, current clinical efforts focus mainly on PAH, including combination therapies and pediatric considerations.

2. How does Selexipag differentiate from other PAH drugs?
It is an oral prostacyclin receptor agonist with a favorable safety profile, offering an alternative to intravenous prostacyclins.

3. Will Selexipag face generic competition?
Patents may protect Selexipag until at least 2027; subsequent generic entry depends on patent litigation outcomes.

4. What is the potential for Selexipag in emerging markets?
Expected to grow as diagnosis and treatment infrastructure improve, though price and reimbursement issues remain.

5. Are combination therapies likely to impact Selexipag sales?
Yes, as evidence supports combining Selexipag with other PAH drugs, sales may increase, but intensified competition could reduce its market share.

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Citations

[1] European Medicines Agency. (2015). Veletri (selexipag) approval decision.
[2] FDA. (2015). Selexipag (Uptravi) approval announcement.
[3] Market Study. (2022). Global Pulmonary Arterial Hypertension Market.
[4] ClinicalTrials.gov. (2023). Selexipag trials.