Dydrogesterone
As of the edition of 20 October 2026, Dydrogesterone is a small molecule: marketed, first approved in 1963 (CH); acts on PGR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Gynorest
- First approved
- 24 July 1963 (CH)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- Theramex; 5 holders in all
- Registered trials
- 47, 2 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Cancer; Hormones
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Dydrogesterone.
See the 2 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 | 23 | 8 | 3 | 1 |
| Phase 1 | 2 | 1 | 0 | 0 |
| Phase 3 | 11 | 9 | 1 | 0 |
| Phase 4 | 11 | 6 | 0 | 1 |
| All trials | 47 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Labatec Pharma | Applicant | 1963 to now |
| Abbott | Applicant and Lead sponsor of trials | 2003 to now |
| Solvay Pharmaceuticals | Applicant and Lead sponsor of trials | 2005 to now |