Metreleptin
As of the edition of 20 October 2026, Metreleptin is a protein: marketed, first approved in 2013 (JP); acts on LEPR; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Protein
- Brand name
- Myalept
- First approved
- 25 March 2013 (JP)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- CHIESI FARMACĂUTICA LTDA; 3 holders in all
- Registered trials
- 33, 4 stopped early
- Disease areas
- Nutrition and metabolism; Skin and connective tissue; Hormones; Inherited and neonatal; Digestive system; Immune system
US protection
US protection ended in 2026.
US protection ended in 2026, 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 Chiesi Farmaceutici. 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.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| LEPR | Leptin receptor | P48357 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 1 | 1 |
| Phase 1 | 2 | 1 | 0 | 1 |
| Phase 2 | 20 | 15 | 4 | 1 |
| Phase 3 | 4 | 0 | 2 | 1 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 33 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Shionogi | Applicant | 2013 to now |
| Qlt | Applicant and Lead sponsor of trials | 2014 to now |
| Chiesi Farmaceutici | Acquired holder and Lead sponsor of trials | 2016 to now |