Lixisenatide
As of the edition of 20 October 2026, Lixisenatide is a protein: marketed, first approved in 2013 (JP); acts on GLP1R; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Protein
- Brand name
- Adlyxin
- First approved
- 24 May 2013 (JP)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Withdrawn from market
- 18 December 2025 (in some regions)
- Registered trials
- 56, 4 stopped early
- Disease areas
- Hormones; Nutrition and metabolism; Heart and blood vessels; Immune system; Nervous system; Pregnancy and women's health
US protection
US protection ends in 2028.
US protection ends in 2028, 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 product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Lixisenatide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GLP1R | Glucagon-like peptide 1 receptor | P43220 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 5 | 4 | 0 | 1 |
| Phase 2 | 6 | 5 | 0 | 1 |
| Phase 3 | 33 | 32 | 0 | 1 |
| Phase 4 | 11 | 7 | 3 | 1 |
| All trials | 56 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant and Lead sponsor of trials | 2006 to now |