Teplizumab
As of the edition of 20 October 2026, Teplizumab is an antibody: marketed, first approved in 2022 (US); acts on CD3E; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Antibody
- Brand name
- Tzield
- First approved
- 17 November 2022 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Sanofi; 3 holders in all
- Registered trials
- 21, 5 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Immune system; Bones, joints and muscles; Skin and connective tissue
US protection
US protection ends in 2034.
US protection ends in 2034, 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 Teplizumab.
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 |
|---|---|---|
| CD3E | T-cell surface glycoprotein CD3 epsilon chain | P07766 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 1 | 5 | 0 |
| Phase 1 | 2 | 0 | 1 | 1 |
| Phase 2 | 8 | 3 | 1 | 3 |
| Phase 3 | 4 | 2 | 1 | 1 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant and Lead sponsor of trials | 2019 to now |