Mecasermin
As of the edition of 20 October 2026, Mecasermin is a protein: marketed, first approved in 2005 (US); acts on IGF1R; US protection ended in 2017.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2007
- Kind
- Protein
- Brand name
- Increlex
- First approved
- 30 August 2005 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Esteve Pharmaceuticals; 3 holders in all
- Registered trials
- 21, 9 stopped early
- Disease areas
- Hormones; Inherited and neonatal; Bones, joints and muscles; Mental health; Nutrition and metabolism; Digestive system
US protection
US protection ended in 2017.
US protection ended in 2017, 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 Eton Pharmaceuticals. 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 product2 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Mecasermin.
Target
| Gene | Protein | UniProt |
|---|---|---|
| IGF1R | Insulin-like growth factor 1 receptor | P08069 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 1 | 2 |
| Phase 1 | 3 | 1 | 0 | 2 |
| Phase 2 | 8 | 5 | 0 | 3 |
| Phase 3 | 5 | 3 | 0 | 2 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Esteve Pharmaceuticals | Applicant and Lead sponsor of trials | 2007 to now |
| Eton Pharmaceuticals | Acquired holder | 2025 to now |
| Ipsen | Acquired holder | 2025 to now |