Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Selexipag clinical trials

Also listed in trial records as JNJ-67896049, Uptravi, ACT-293987
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 4 trials in our China, Belgium, Poland, Taiwan, USA, Germany, France, Canada, Brazil, South Korea, Israel, Ireland, Spain, Italy, Sweden, Switzerland, Portugal, Turkey, Mexico, Australia and UK registers that name Selexipag as an intervention. Synced 10 Nov 2026
4Current trials
2Recruiting now
2Lead sponsors
21Country registers
At a glance

Selexipag is named as an intervention in 4 current clinical trials in our China, Belgium, Poland, Taiwan, USA, Germany, France, Canada, Brazil, South Korea, Israel, Ireland, Spain, Italy, Sweden, Switzerland, Portugal, Turkey, Mexico, Australia and UK registers. 2 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Actelion (3). The most-studied condition is Hypertension, Pulmonary.

Where Selexipag is approved

All regulators →

Of the three regulators tracked here, the first to approve Selexipag was the US, on 21 Dec 2015. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
21 Dec 2015
Uptravi
NDA207947 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
12 May 2016
Uptravi
EMA product page
First centralised authorisation
CACanada (Health Canada)
20 Jan 2016
Uptravi
Notice of Compliance 17697
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Selexipag patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Selexipag, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Uptravi
  • 6 listed patents; the last listed expires 1 Jun 2037 (US 10828298, including a 6-month paediatric extension).
  • Latest patent on the drug substance itself: 1 Feb 2031 (US 8791122, with paediatric extension).
  • Exclusivity PED: Pediatric exclusivity, until 23 Nov 2029.
  • Exclusivity NPP: New patient population, until 23 May 2029.
  • Exclusivity NS: New strength, until 23 May 2029.
See the Orange Book listing for NDA 214275
Patents and exclusivities above are pooled across 2 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Selexipag

All medicines →
ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$318.4m
13,987 prescriptions in 2025 · Uptravi, UPTRAVI Titration Pack
+13% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Selexipag works

All drug targets →
  • Prostanoid IP receptor agonist Agonist
    Target: PTGIR prostaglandin I2 receptor
    ✓ In ChEMBL and the Guide to Pharmacology
Other medicines acting on PTGIR

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL238804, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7552, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Selexipag

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 25 products on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • EU
    European Union: Uptravi
    EMA product information: package leaflet and summary of product characteristics in every EU language.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Selexipag

ATC code
B01AC27
ChEMBL
CHEMBL238804
DrugBank
DB11362
PubChem CID
9913767
CAS number
475086-01-2
FDA UNII
5EXC0E384L
Wikidata
Q15424759
Wikipedia
Selexipag

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting250%
  • Active, closed250%

Trials by phase

  • Phase 3250%
  • Phase 2125%
  • Phase 4125%
01

Clinical trials of Selexipag

4 trials
StudyPhaseStatusLead sponsorRegisters
Randomized Study of Triple Therapy vs Sildenafil Dose Optimization in Pulmonary Arterial Hypertension
NCT07713914 · ClinicalTrials.gov ↗ · Pulmonary Arterial Hypertension (PAH)
Phase 4 Recruiting University of Sao Paulo General Hospital Brazil
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
NCT05179876 · ClinicalTrials.gov ↗ · Hypertension, Pulmonary
Phase 3 Recruiting Actelion China, Belgium, Poland, South Korea, Taiwan
A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
NCT04175600 · Hypertension, Pulmonary
Phase 3 Active, closed Actelion Ireland, USA, China, Germany, France, Spain, Italy, Belgium, Sweden, Poland, Switzerland, Portugal, Turkey, Canada, Brazil, Mexico, South Korea, Taiwan, Australia, Israel
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
NCT03492177 · Pulmonary Arterial Hypertension
Phase 2 Active, closed Actelion UK, USA, China, Germany, France, Belgium, Poland, Canada, Taiwan, Israel

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Selexipag across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

25 single-substance products containing Selexipag on the HPRA medicines list.

All 25 Irish products →

Supply shortages

No entry for Selexipag in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Selexipag

3 conditions
06

Related compounds

07

Questions about Selexipag trials

How many clinical trials are testing Selexipag?

4 current trials in our China, Belgium, Poland, Taiwan, USA, Germany, France, Canada, Brazil, South Korea, Israel, Ireland, Spain, Italy, Sweden, Switzerland, Portugal, Turkey, Mexico, Australia and UK registers name Selexipag (also registered as JNJ-67896049) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Selexipag trials recruiting patients?

Yes. 2 of the 4 trials are recruiting: 1 with sites in China, 1 with sites in Belgium, 1 with sites in Poland, 1 with sites in Taiwan, 1 with sites in Brazil and 1 with sites in South Korea. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Selexipag clinical trials?

Actelion (3) and University of Sao Paulo General Hospital (1). The number in brackets is how many trials each organisation leads.

Are there Selexipag clinical trials in Ireland?

Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Is Selexipag licensed in Ireland?

Yes. The HPRA medicines list includes 25 single-substance products containing Selexipag, for example Uptravi 100 microgram film-coated tablets (Janssen-Cilag International NV). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Selexipag shortage?

Not in the lists we track: Selexipag has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Selexipag works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Selexipag works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Selexipag (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.