Drug

Selexipag

Approved · EMA

ClassProstanoid IP receptor agonistEmerging researchLate-stage development

Also known as Uptravi.

RxNorm1729002 ChEMBLCHEMBL238804 ATCB01AC27UNII5EXC0E384L

Research papers

Active clinical trials

Prostacyclin receptor

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies

Clinical trial2026-07-06Results expected Q1 2027 · ClinicalTrials.gov

A Multicentre Randomised Cross-over Trial of Disease Specific Therapy in Patients With Pulmonary Arterial Hypertension (PAH) Implanted With Pulmonary Artery Pressure and Cardiac Rhythm Monitoring Devices (CardioMEMS/ConfirmRx)

Clinical trial2026-06-05Results expected Q1 2027 · ClinicalTrials.gov

A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension

Clinical trial2025-10-27Results posted · ClinicalTrials.gov

A Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of Selexipag

Clinical trial2025-06-29Results posted · ClinicalTrials.gov

A Multicenter, Single-arm, Open-label, Long-term Follow-up Safety Study of Selexipag in Participants Who Participated in a Previous Selexipag Study

Clinical trial2025-05-01Results posted · ClinicalTrials.gov

A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their Impacts

Clinical trial2025-03-30Results posted · ClinicalTrials.gov

The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study

Clinical trial2025-03-30Results posted · ClinicalTrials.gov

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial Hypertension

Clinical trial2024-10-11Primary completion · ClinicalTrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Participants With Sarcoidosis-Associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.

Clinical trial2023-04-19Terminated · ClinicalTrials.gov

Approval: Uptravi (EMA)

Regulatory2016-05-12EMA

Selexipag for the Treatment of Pulmonary Arterial Hypertension.

Research2015-12-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Selexipag

Aliases & brands

Uptravi

RxNorm CUI

1729002

ChEMBL ID

CHEMBL238804

ATC codes

B01AC27

UNII

5EXC0E384L

Primary mechanism

Prostanoid IP receptor agonist

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Prostacyclin receptor

PTGIR · P43119

AGONISTProstanoid IP receptor agonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2016-05-12

Latest approval

2016-05-12

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2016-05-12Approval

Approval: Uptravi (EMA)

Indication: Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in… Show full indication

Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.