Insulin aspart
As of the edition of 20 October 2026, Insulin aspart is a protein: marketed, first approved in 1999 (EU); acts on INSR; US protection ended in 2012.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Protein
- Brand name
- Novolog
- First approved
- 7 September 1999 (EU)
- Approvals on record
- 44 in 4 regions
- Holder of the most recent approval
- Novo Nordisk; 3 holders in all
- Withdrawn from market
- 25 January 2024 (in some regions)
- Registered trials
- 313, 9 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Immune system; Pregnancy and women's health; Urinary and reproductive; Nervous system
US protection
US protection ended in 2012.
US protection ended in 2012, 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 product5 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| INSR | Insulin receptor | P06213 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 81 | 74 | 2 | 2 |
| Phase 1 | 60 | 56 | 3 | 0 |
| Phase 2 | 15 | 14 | 0 | 0 |
| Phase 3 | 81 | 76 | 1 | 3 |
| Phase 4 | 76 | 67 | 0 | 4 |
| All trials | 313 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novo Nordisk | Applicant and Lead sponsor of trials | 1989 to now |
| Sanofi | Applicant and Lead sponsor of trials | 2007 to now |