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i.v. selexipag
i.v. selexipag is a prostacyclin receptor agonist Small molecule drug developed by Actelion. It is currently in Phase 3 development for Pulmonary arterial hypertension (PAH). Also known as: ACT-293987.
Selexipag is a prostacyclin receptor agonist that acts as a potent vasodilator.
Selexipag is a small molecule that acts as a prostanoid IP receptor agonist. It is used to treat Pulmonary Arterial Hypertension, a condition where the blood pressure in the lungs is elevated.
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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 | i.v. selexipag |
|---|---|
| Also known as | ACT-293987 |
| 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 prostacyclin receptor, leading to increased levels of cyclic AMP in vascular smooth muscle cells, resulting in vasodilation and improved blood flow. This mechanism is particularly beneficial for patients with pulmonary arterial hypertension (PAH).
Approved indications
- Pulmonary arterial hypertension (PAH)
Common side effects
- Headache
- Nausea
- Dizziness
Key clinical trials
- Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension (PHASE3)
- Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects (PHASE1)
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:
- i.v. selexipag CI brief — competitive landscape report
- i.v. selexipag updates RSS · CI watch RSS
- Actelion portfolio CI
Frequently asked questions about i.v. selexipag
What is i.v. selexipag?
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Is i.v. selexipag also known as anything else?
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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 (PAH)
- Also known as: ACT-293987
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing