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iloprost (5 µg)
iloprost (5 µg) is a prostacyclin analogue Small molecule drug developed by Actelion. It is currently in Phase 3 development for Pulmonary arterial hypertension. Also known as: Ventavis(R).
Iloprost is a prostacyclin analogue that acts as a vasodilator and inhibits platelet aggregation.
Iloprost is a prostacyclin analogue that acts as a vasodilator and inhibits platelet aggregation. Used for Pulmonary arterial hypertension.
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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 | iloprost (5 µg) |
|---|---|
| Also known as | Ventavis(R) |
| Sponsor | Actelion |
| Drug class | prostacyclin analogue |
| Target | prostacyclin receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Iloprost works by binding to and activating the prostacyclin receptor, leading to relaxation of vascular smooth muscle and inhibition of platelet aggregation. This results in vasodilation and improved blood flow, which can be beneficial in treating conditions such as pulmonary arterial hypertension.
Approved indications
- Pulmonary arterial hypertension
Common side effects
- Headache
- Dizziness
- Nausea
- Flushing
- Palpitations
Key clinical trials
- Iloprost Power 15 in Pulmonary Arterial Hypertension (PHASE3)
- Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension (PHASE4)
- Iloprost for Bridging to Heart Transplantation in PH (PHASE2)
- Comparative PK PD Study in PAH Patients (Fox vs. I-Neb) (PHASE1, PHASE2)
- The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting (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:
- iloprost (5 µg) CI brief — competitive landscape report
- iloprost (5 µg) updates RSS · CI watch RSS
- Actelion portfolio CI
Frequently asked questions about iloprost (5 µg)
What is iloprost (5 µg)?
How does iloprost (5 µg) work?
What is iloprost (5 µg) used for?
Who makes iloprost (5 µg)?
Is iloprost (5 µg) also known as anything else?
What drug class is iloprost (5 µg) in?
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What are the side effects of iloprost (5 µg)?
What does iloprost (5 µg) target?
Related
- Drug class: All prostacyclin analogue drugs
- Target: All drugs targeting prostacyclin receptor
- Manufacturer: Actelion — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Pulmonary arterial hypertension
- Also known as: Ventavis(R)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing