SIPULEUCEL-T
As of the edition of 20 October 2026, SIPULEUCEL-T is a cell: marketed, first approved in 2010 (US); acts on ACP3; US protection ended in 2022.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Cell
- Brand name
- Provenge
- First approved
- 29 April 2010 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Dendreon Pharmaceuticals
- Registered trials
- 29, 4 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health
US protection
US protection ended in 2022.
US protection ended in 2022, 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 Dendreon Pharmaceuticals. 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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ACP3 | Prostatic acid phosphatase | P15309 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 1 |
| Phase 1 | 6 | 3 | 3 | 0 |
| Phase 2 | 18 | 12 | 3 | 3 |
| Phase 3 | 2 | 2 | 0 | 0 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Dendreon Pharmaceuticals | Applicant | 2010 to now |