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selexipag (Uptravi)
selexipag (Uptravi) is a prostacyclin receptor agonist Small molecule drug developed by Actelion. It is currently in Phase 3 development for Pulmonary arterial hypertension. Also known as: ACT-293987, JNJ-67896049.
Selexipag is a prostacyclin receptor agonist that acts as a selective IP receptor agonist.
Selexipag, a small molecule, is used to treat Pulmonary Arterial Hypertension and Schistosomiasis-Associated Pulmonary Arterial Hypertension. It is indicated for the treatment of Pulmonary Hypertension, specifically Pulmonary Arterial Hypertension, according to ClinicalTrials.gov.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | selexipag (Uptravi) |
|---|---|
| Also known as | ACT-293987, JNJ-67896049 |
| Sponsor | Actelion |
| Drug class | prostacyclin receptor agonist |
| Target | IP receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Selexipag works by binding to the IP receptor, which leads to vasodilation and improved exercise capacity in patients with pulmonary arterial hypertension. This mechanism of action is thought to be beneficial in reducing symptoms and improving quality of life for patients with this condition.
Approved indications
- Pulmonary arterial hypertension
Common side effects
- Headache
- Nausea
- Dizziness
Key clinical trials
- Individual Patient Expanded Access IND for Selexipag (Uptravi) in Participants With Non-healing Wound, Buerger's Disease
- A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension (PHASE2)
- A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option (PHASE3)
- A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension (PHASE3)
- Long-Term Outcomes of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension
- Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension
- Selexipag (ACT-293987) in Pulmonary Arterial Hypertension (PHASE3)
- Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- selexipag (Uptravi) CI brief — competitive landscape report
- selexipag (Uptravi) updates RSS · CI watch RSS
- Actelion portfolio CI
Frequently asked questions about selexipag (Uptravi)
What is selexipag (Uptravi)?
How does selexipag (Uptravi) work?
What is selexipag (Uptravi) used for?
Who makes selexipag (Uptravi)?
Is selexipag (Uptravi) also known as anything else?
What drug class is selexipag (Uptravi) in?
What development phase is selexipag (Uptravi) in?
What are the side effects of selexipag (Uptravi)?
What does selexipag (Uptravi) target?
Related
- Drug class: All prostacyclin receptor agonist drugs
- Target: All drugs targeting IP receptor
- Manufacturer: Actelion — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Pulmonary arterial hypertension
- Also known as: ACT-293987, JNJ-67896049
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing