Axicabtagene ciloleucel
As of the edition of 20 October 2026, Axicabtagene ciloleucel is a gene: marketed, first approved in 2017 (US); acts on CD19; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Gene
- Brand name
- Yescarta
- First approved
- 18 October 2017 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Gilead Sciences; 2 holders in all
- Registered trials
- 44, 3 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Chemically induced; Heart and blood vessels; Infections
US protection
US protection ends in 2033.
The orphan exclusivity ends in 2033 (it covers one use only). The application that gives this date is held by Gilead Sciences.
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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Target
| Gene | Protein | UniProt |
|---|---|---|
| CD19 | B-lymphocyte antigen CD19 | P15391 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 0 | 2 | 0 |
| Phase 1 | 8 | 1 | 5 | 2 |
| Phase 2 | 26 | 10 | 14 | 1 |
| Phase 3 | 4 | 1 | 3 | 0 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 44 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Applicant and Lead sponsor of trials | 2017 to now |