Insulin lispro
As of the edition of 20 October 2026, Insulin lispro is a protein: marketed, first approved in 1996 (EU); acts on INSR; US protection ended in 2008.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Protein
- Brand name
- Humalog
- First approved
- 30 April 1996 (EU)
- Approvals on record
- 54 in 5 regions
- Holder of the most recent approval
- Eli Lilly; 4 holders in all
- Withdrawn from market
- 19 February 2001 (in some regions)
- Registered trials
- 112, 15 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Immune system; Heart and blood vessels; Mental health; Nervous system
US protection
US protection ended in 2008.
US protection ended in 2008, 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 Eli Lilly. 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 | 19 | 13 | 2 | 3 |
| Phase 1 | 24 | 17 | 1 | 6 |
| Phase 2 | 13 | 12 | 0 | 0 |
| Phase 3 | 26 | 21 | 0 | 4 |
| Phase 4 | 30 | 25 | 2 | 2 |
| All trials | 112 |