Progesterone
As of the edition of 20 October 2026, Progesterone is a small molecule: marketed, first approved in 1980 (FR); acts on PGR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Progestasert
- First approved
- 15 January 1980 (FR)
- Approvals on record
- 32 in 7 regions
- Holder of the most recent approval
- CSL Behring; 18 holders in all
- Registered trials
- 253, 30 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Cancer; Mental health; Hormones; Inherited and neonatal
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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Progesterone.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PGR | Progesterone receptor | P06401 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 63 | 35 | 10 | 8 |
| Phase 1 | 25 | 13 | 4 | 2 |
| Phase 2 | 40 | 23 | 4 | 7 |
| Phase 3 | 54 | 32 | 8 | 8 |
| Phase 4 | 71 | 45 | 9 | 5 |
| All trials | 253 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| CSL Behring | Applicant | 1980 to now |
| Merck & Co. | Later holder | 1998 to now |
| Merck KGaA | Later holder and Lead sponsor of trials | 2004 to now |
| Ferring Pharmaceuticals | Later holder and Lead sponsor of trials | 2005 to now |
| IBSA Institut Biochimique | Later holder and Lead sponsor of trials | 2005 to now |
| AbbVie | Acquired holder and Lead sponsor of trials | 2011 to now |
| ASKA Pharmaceutical | Applicant | 2016 to now |
| Actavis Laboratories Ut | Acquired holder | 2017 to now |
| Acertis Pharmaceuticals | Acquired holder | 2025 to now |
| Eli Lilly | Applicant | |
| Johnson & Johnson | Later holder |