Thyrotropin alfa
As of the edition of 20 October 2026, Thyrotropin alfa is a protein: marketed, first approved in 1998 (US); acts on TSHR; US protection ended in 2014.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2002
- Kind
- Protein
- Brand name
- Thyrogen
- First approved
- 30 November 1998 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Registered trials
- 13, 0 stopped early
- Disease areas
- Hormones; Cancer; Blood and lymph; Eye; Heart and blood vessels; Immune system
US protection
US protection ended in 2014.
The orphan exclusivity ended in 2014 (it covers one use only). The application that gives this date is held by Sanofi.
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 product2 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| TSHR | Thyrotropin receptor | P16473 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 6 | 4 | 2 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 1998 to now |