Mifepristone
As of the edition of 20 October 2026, Mifepristone is a small molecule: marketed, first approved in 1988 (FR); acts on NR3C1 and PGR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Mifeprex
- First approved
- 28 December 1988 (FR)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- Linepharma; 6 holders in all
- Registered trials
- 137, 30 stopped early
- Disease areas
- Cancer; Mental health; Urinary and reproductive; Pregnancy and women's health; Hormones; Skin and connective tissue
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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Mifepristone.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 26 | 16 | 0 | 7 |
| Phase 1 | 16 | 11 | 1 | 2 |
| Phase 2 | 35 | 18 | 4 | 10 |
| Phase 3 | 27 | 16 | 2 | 4 |
| Phase 4 | 33 | 21 | 1 | 7 |
| All trials | 137 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Population Council | Applicant | 2000 to now |
| Danco | Acquired holder | 2003 to now |
| Corcept Therapeutics | Later holder and Lead sponsor of trials | 2003 to now |
| Linepharma | Applicant and Lead sponsor of trials | 2022 to now |