Teduglutide
As of the edition of 20 October 2026, Teduglutide is a protein: marketed, first approved in 2012 (EU); acts on GLP2R; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Protein
- Brand name
- Gattex Kit
- First approved
- 30 August 2012 (EU)
- Approvals on record
- 8 in 7 regions
- Holder of the most recent approval
- Cipla Europe; 4 holders in all
- Registered trials
- 39, 0 stopped early
- Disease areas
- Digestive system; Nutrition and metabolism; Heart and blood vessels; Immune system; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ended in 2026.
The last listed US exclusivity ended in 2026. The application that gives this date is held by Takeda.
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.
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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 Teduglutide.
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 |
|---|---|---|
| GLP2R | Glucagon-like peptide 2 receptor | O95838 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 4 | 1 | 0 |
| Phase 1 | 7 | 7 | 0 | 0 |
| Phase 2 | 6 | 5 | 1 | 0 |
| Phase 3 | 18 | 17 | 1 | 0 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 39 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant, Acquired holder and Lead sponsor of trials | 2003 to now |