EMA · European Union
treprostinil — EMA regulatory status
treprostinil (TREPROSTINIL SCIPHARM SÀRL) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- TREPROSTINIL SCIPHARM SÀRL
- Originator
- United Therapeutics Europe Ltd
- Mechanism
- Prostanoid IP receptor agonist
- Target
- Prostacyclin receptor
- Structured fields
- 8
Sponsor / originator context: United Therapeutics Europe Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Prostanoid IP receptor agonist. Target: Prostacyclin receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 43 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| INS1009-203 | Phase 3 | Insmed Incorporated | 2023-505539-11-00 |
| INS1009-212 | Phase 3 | Insmed Incorporated | 2023-505540-19-00 |
| INS1009-311 | Phase 3 | Insmed Incorporated | 2025-521558-40-00 |
| Inhaled Treprostinil | Phase 3 | United Therapeutics Europe | NCT04905693 |
| Inhaled treprostinil | Phase 3 | United Therapeutics Europe | NCT00147199, NCT02630316 |
| Inhaled treprostinil solution | Phase 3 | United Therapeutics Europe | NCT03496623, NCT03794583 |
| Oral Treprostinil | Phase 3 | United Therapeutics Europe | NCT03055234 |
| Oral Treprostinil | Phase 3 | United Therapeutics Europe | NCT01027949, NCT02999906 |
| Oral treprostinil | Phase 3 | United Therapeutics Europe | NCT02603068, NCT03037580 |
| Oral treprostinil (UT-15C) sustained release tablets | Phase 3 | United Therapeutics Europe | NCT00325403, NCT00325442 |
| RIN-PF-303 | Phase 3 | United Therapeutics Europe | 2024-514761-19-00 |
| RIN-PF-305 | Phase 3 | United Therapeutics Europe | 2023-504904-26-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12357599 | Prodrugs of treprostinil | US |
| 12173021 | Treprostinil prodrugs | US |
| 12168071 | Treprostinil derivatives and their use in pharmaceutical compositions | US |
| 11826328 | Stable treprostinil prodrugs | US |
| 11826327 | Treatment for interstitial lung disease | US |
| 11723887 | Process to prepare treprostinil, the active ingredient in Remodulin® | US |
| 11672775 | Treprostinil prodrugs | US |
| 11634443 | Treprostinil prodrugs | US |
| 11571444 | Enhancement of MSC immunomodulatory properties by treprostinil | US |
| 11357782 | Treprostinil administration by inhalation | US |
| 11236035 | Salts of treprostinil | US |
| 10716793 | Treprostinil administration by inhalation | US |
Related hubs
FAQ
What is the EMA approval status of treprostinil?
treprostinil currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get treprostinil regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to treprostinil?
This spoke lists 43 published programs associated with treprostinil in our pipeline index.