Insulin glargine
As of the edition of 20 October 2026, Insulin glargine is a protein: marketed, first approved in 2000 (US); 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 2017
- Kind
- Protein
- Brand name
- Lantus
- First approved
- 20 April 2000 (US)
- Approvals on record
- 38 in 5 regions
- Holder of the most recent approval
- BIOCON BIOLOGICS DO BRASIL LTDA; 8 holders in all
- Withdrawn from market
- 29 October 2018 (in some regions)
- Registered trials
- 335, 22 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Immune system; Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive
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 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 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 | 21 | 17 | 1 | 2 |
| Phase 1 | 35 | 34 | 0 | 0 |
| Phase 2 | 14 | 11 | 1 | 1 |
| Phase 3 | 119 | 111 | 0 | 6 |
| Phase 4 | 146 | 126 | 3 | 13 |
| All trials | 335 |