Insulin degludec
As of the edition of 20 October 2026, Insulin degludec is a protein: marketed, first approved in 2012 (JP); acts on INSR; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Protein
- Brand name
- Tresiba
- First approved
- 28 September 2012 (JP)
- Approvals on record
- 19 in 3 regions
- Holder of the most recent approval
- Novo Nordisk; 2 holders in all
- Registered trials
- 169, 2 stopped early
- Disease areas
- Hormones; Nutrition and metabolism; Immune system; Lungs and airways; Digestive system; Pregnancy and women's health
US protection
US protection ends in 2027.
US protection ends in 2027, 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 Novo Nordisk. 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 product3 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 3 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| INSR | Insulin receptor | P06213 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 26 | 24 | 0 | 1 |
| Phase 1 | 53 | 50 | 1 | 1 |
| Phase 2 | 7 | 7 | 0 | 0 |
| Phase 3 | 72 | 68 | 0 | 0 |
| Phase 4 | 11 | 10 | 0 | 0 |
| All trials | 169 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novo Nordisk | Applicant and Lead sponsor of trials | 2005 to now |