Clomiphene
As of the edition of 20 October 2026, Clomiphene is a small molecule: marketed, first approved in 1966 (ES); acts on ESR1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Clomid
- First approved
- 1 December 1966 (ES)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- Fuji Pharma Co., Ltd; 6 holders in all
- Registered trials
- 77, 7 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Hormones; Cancer; Nutrition and metabolism; Inherited and neonatal
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 Clomiphene.
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 |
|---|---|---|
| ESR1 | Estrogen receptor | P03372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 13 | 1 | 2 |
| Phase 1 | 6 | 4 | 0 | 0 |
| Phase 2 | 13 | 8 | 1 | 3 |
| Phase 3 | 11 | 6 | 2 | 1 |
| Phase 4 | 23 | 15 | 3 | 1 |
| All trials | 77 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck KGaA | Acquired holder | 2008 to now |
| Sanofi | Applicant |