Obecabtagene autoleucel
As of the edition of 20 October 2026, Obecabtagene autoleucel is a gene: marketed, first approved in 2024 (US); acts on CD19; 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
- Gene
- Brand name
- Aucatzyl
- First approved
- 8 November 2024 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Autolus
- Registered trials
- 7, 0 stopped early
- Disease areas
- Immune system; Blood and lymph; Cancer; Infections; Skin and connective tissue; Nervous system
US protection
US protection ends in 2036.
The reference-product exclusivity ends in 2036. The application that gives this date is held by Autolus.
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 Obecabtagene autoleucel.
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 |
|---|---|---|
| CD19 | B-lymphocyte antigen CD19 | P15391 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 3 | 0 | 3 | 0 |
| Phase 2 | 4 | 0 | 4 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Autolus | Originator and Lead sponsor of trials | 2020 to now |