Aldesleukin
As of the edition of 20 October 2026, Aldesleukin is a protein: marketed, first approved in 1989 (FR); acts on IL2RA and IL2RB; US protection ended in 2005.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2000
- Kind
- Protein
- Brand name
- Proleukin
- First approved
- 15 September 1989 (FR)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Iovance Biotherapeutics; 3 holders in all
- Registered trials
- 637, 144 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Urinary and reproductive; Immune system; Pregnancy and women's health; Blood and lymph
US protection
US protection ended in 2005.
The orphan exclusivity ended in 2005 (it covers one use only). The application that gives this date is held by Iovance Biotherapeutics Manufacturing.
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
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Aldesleukin.
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Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 28 | 17 | 5 | 3 |
| Phase 1 | 192 | 97 | 36 | 42 |
| Phase 2 | 368 | 182 | 54 | 95 |
| Phase 3 | 40 | 28 | 2 | 2 |
| Phase 4 | 9 | 5 | 1 | 2 |
| All trials | 637 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Clinigen | Earlier holder | 1992 to now |
| Iovance Biotherapeutics Manufacturing | Acquired holder | 2024 to now |