Follitropin alfa
As of the edition of 20 October 2026, Follitropin alfa is a protein: marketed, first approved in 1995 (EU); acts on FSHR; US protection ended in 2009.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Protein
- Brand name
- Gonal-f
- First approved
- 20 October 1995 (EU)
- Approvals on record
- 16 in 3 regions
- Holder of the most recent approval
- Merck KGaA; 3 holders in all
- Registered trials
- 78, 6 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Hormones; Cancer; Heart and blood vessels; Nutrition and metabolism
US protection
US protection ended in 2009.
US protection ended in 2009, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Merck KGaA. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product4 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| FSHR | Follicle-stimulating hormone receptor | P23945 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 27 | 20 | 4 | 1 |
| Phase 1 | 9 | 7 | 1 | 0 |
| Phase 2 | 4 | 3 | 0 | 0 |
| Phase 3 | 22 | 17 | 1 | 1 |
| Phase 4 | 16 | 6 | 1 | 4 |
| All trials | 78 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck KGaA | Applicant and Lead sponsor of trials | 1995 to now |