Ulipristal acetate
As of the edition of 20 October 2026, Ulipristal acetate is a small molecule: marketed, first approved in 2009 (EU); acts on PGR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Ella
- First approved
- 15 May 2009 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Laboratoire Hra Pharma
- Withdrawn from market
- 1 January 2020 (in some regions)
- Registered trials
- 52, 11 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Skin and connective tissue; Blood and lymph; Heart and blood vessels
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PGR | Progesterone receptor | P06401 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 5 | 0 | 1 |
| Phase 1 | 7 | 5 | 0 | 2 |
| Phase 2 | 8 | 5 | 1 | 2 |
| Phase 3 | 14 | 12 | 0 | 2 |
| Phase 4 | 15 | 4 | 0 | 4 |
| All trials | 52 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Laboratoire Hra Pharma | Applicant | 2009 to now |