Norgestimate
As of the edition of 20 October 2026, Norgestimate is a small molecule: marketed, first approved in 1989 (US); acts on PGR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Ortho CYCLEN-21
- First approved
- 29 December 1989 (US)
- Approvals on record
- 11 in 4 regions
- Holder of the most recent approval
- GLENMARK PHARMACEUTICALS CANADA INC.; 6 holders in all
- Registered trials
- 16, 1 stopped early
- Disease areas
- Digestive system; Infections; Skin and connective tissue; Urinary and reproductive; Bones, joints and muscles; Immune system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PGR | Progesterone receptor | P06401 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 10 | 9 | 0 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 4 | 4 | 4 | 0 | 0 |
| All trials | 16 |