Nomegestrol acetate
As of the edition of 20 October 2026, Nomegestrol acetate is a small molecule: marketed, first approved in 1983 (FR); acts on PGR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Zoely
- First approved
- 18 November 1983 (FR)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Theramex; 2 holders in all
- Withdrawn from market
- 31 July 2014 (in some regions)
- Registered trials
- 17, 4 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Immune system; Nervous system
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 Nomegestrol acetate.
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 1 | 2 | 1 | 0 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 9 | 5 | 0 | 3 |
| Phase 4 | 4 | 3 | 0 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Theramex | Applicant and Lead sponsor of trials | 1997 to now |