Zolbetuximab
As of the edition of 20 October 2026, Zolbetuximab is an antibody: marketed, first approved in 2024 (JP); acts on CLDN18; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Antibody
- Brand name
- Vyloy
- First approved
- 26 March 2024 (JP)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Astellas; 3 holders in all
- Registered trials
- 22, 0 stopped early
- Disease areas
- Cancer; Digestive system; Hormones
US protection
US protection ends in 2036.
US protection ends in 2036, 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 Astellas. 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 Zolbetuximab.
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 |
|---|---|---|
| CLDN18 | Claudin-18 | P56856 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 1 | 0 |
| Phase 1 | 4 | 3 | 1 | 0 |
| Phase 2 | 11 | 2 | 9 | 0 |
| Phase 3 | 3 | 0 | 3 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Applicant and Lead sponsor of trials | 2018 to now |