Gonadotropin, chorionic
As of the edition of 20 October 2026, Gonadotropin, chorionic is a protein: marketed, first approved in 1973 (US); acts on LHCGR; US protection ended in 1985.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Protein
- Brand name
- Novarel
- First approved
- 5 March 1973 (US)
- Approvals on record
- 35 in 3 regions
- Holder of the most recent approval
- IBSA PHARMA SAS; 7 holders in all
- Registered trials
- 69, 7 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Hormones; Cancer; Inherited and neonatal; Nervous system
US protection
US protection ended in 1985.
US protection ended in 1985, 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 Fresenius Kabi. 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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| LHCGR | Lutropin-choriogonadotropic hormone receptor | P22888 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 15 | 2 | 0 |
| Phase 1 | 4 | 3 | 1 | 0 |
| Phase 2 | 11 | 5 | 0 | 4 |
| Phase 3 | 9 | 5 | 2 | 2 |
| Phase 4 | 26 | 18 | 0 | 1 |
| All trials | 69 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ferring Pharmaceuticals | Later holder and Lead sponsor of trials | 1974 to now |
| Bel-Mar | Later holder | 1974 to now |
| Organon | Later holder and Lead sponsor of trials | 1976 to now |
| Fresenius Kabi | Acquired holder | 2013 to now |
| Bristol Myers Squibb | Later holder |