Estetrol anhydrous
As of the edition of 20 October 2026, Estetrol anhydrous is a small molecule: marketed, first approved in 2021 (CA); acts on ESR1 and ESR2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Nextstellis
- First approved
- 5 March 2021 (CA)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Gedeon Richter; 5 holders in all
- Registered trials
- 22, 0 stopped early
- Disease areas
- Urinary and reproductive; Cancer; Pregnancy and women's health; Skin and connective tissue; Heart and blood vessels; Infections
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 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Estetrol anhydrous.
See the 2 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 | 2 | 1 | 1 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 7 | 6 | 0 | 0 |
| Phase 3 | 5 | 4 | 1 | 0 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Estetra SPRL | Later holder | 2021 to now |
| Gedeon Richter | Applicant | 2021 to now |