Insulin glulisine
As of the edition of 20 October 2026, Insulin glulisine is a protein: marketed, first approved in 2004 (US); acts on INSR; US protection ended in 2016.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Protein
- Brand name
- Apidra
- First approved
- 16 April 2004 (US)
- Approvals on record
- 11 in 4 regions
- Holder of the most recent approval
- Sanofi
- Registered trials
- 72, 7 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Immune system; Nervous system; Mental health; Heart and blood vessels
US protection
US protection ended in 2016.
US protection ended in 2016, 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 Sanofi. 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.
See the exact date and the 1 listing 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 | 1 | 0 | 0 | 1 |
| Phase 1 | 10 | 10 | 0 | 0 |
| Phase 2 | 4 | 3 | 0 | 1 |
| Phase 3 | 21 | 21 | 0 | 0 |
| Phase 4 | 36 | 29 | 0 | 5 |
| All trials | 72 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 2001 to now |