Tesamorelin
As of the edition of 20 October 2026, Tesamorelin is a protein: marketed, first approved in 2010 (US); acts on GHRHR; US protection ended in 2022.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Protein
- Brand name
- Egrifta
- First approved
- 10 November 2010 (US)
- Approvals on record
- 5 in 1 region
- Holder of the most recent approval
- Theratechnologies
- Registered trials
- 19, 7 stopped early
- Disease areas
- Nutrition and metabolism; Nervous system; Skin and connective tissue; Hormones; Immune system; Infections
US protection
US protection ended in 2022.
US protection ended in 2022, 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 Theratechnologies. 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.
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 Tesamorelin.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GHRHR | Growth hormone-releasing hormone receptor | Q02643 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 3 | 0 | 3 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 7 | 3 | 2 | 2 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 2 | 0 | 0 | 2 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Theratechnologies | Originator and Lead sponsor of trials | 2002 to now |