Epoprostenol
As of the edition of 20 October 2026, Epoprostenol is a small molecule: marketed, first approved in 1988 (ES); acts on PTGIR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Flolan
- First approved
- 1 May 1988 (ES)
- Approvals on record
- 12 in 6 regions
- Holder of the most recent approval
- Johnson & Johnson; 6 holders in all
- Registered trials
- 19, 3 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Skin and connective tissue; Hormones; Infections; Nervous system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Epoprostenol.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PTGIR | Prostacyclin receptor | P43119 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 3 | 0 | 0 |
| Phase 1 | 2 | 1 | 0 | 1 |
| Phase 2 | 3 | 1 | 0 | 2 |
| Phase 3 | 4 | 3 | 1 | 0 |
| Phase 4 | 7 | 7 | 0 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator and Lead sponsor of trials | 1995 to now |
| Johnson & Johnson | Applicant, Acquired holder and Lead sponsor of trials | 2011 to now |