Dienogest
As of the edition of 20 October 2026, Dienogest is a small molecule: marketed, first approved in 2008 (FR); 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
- Natazia
- First approved
- 10 December 2008 (FR)
- Approvals on record
- 10 in 6 regions
- Holder of the most recent approval
- Mochida Pharmaceutical; 4 holders in all
- Registered trials
- 42, 3 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Cancer; Skin and connective tissue; Bones, joints and muscles; 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.
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 Dienogest.
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 |
|---|---|---|
| PGR | Progesterone receptor | P06401 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 10 | 2 | 1 |
| Phase 1 | 5 | 4 | 1 | 0 |
| Phase 2 | 3 | 2 | 0 | 1 |
| Phase 3 | 10 | 8 | 0 | 0 |
| Phase 4 | 10 | 3 | 0 | 1 |
| All trials | 42 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant and Lead sponsor of trials | 2005 to now |
| Mochida Pharmaceutical | Applicant | 2020 to now |