Sargramostim
As of the edition of 20 October 2026, Sargramostim is a protein: marketed, first approved in 1991 (US); acts on CSF2RA; US protection ended in 2025.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Protein
- Brand name
- Leukine
- First approved
- 5 March 1991 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Partner Therapeutics; 2 holders in all
- Registered trials
- 325, 48 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Skin and connective tissue; Urinary and reproductive; Infections
US protection
US protection ended in 2025.
The orphan exclusivity ended in 2025 (it covers one use only). The application that gives this date is held by Partner Therapeutics.
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 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Sargramostim.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CSF2RA | Granulocyte-macrophage colony-stimulating factor receptor subunit alpha | P15509 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 9 | 0 | 1 |
| Phase 1 | 79 | 59 | 3 | 12 |
| Phase 2 | 203 | 141 | 20 | 29 |
| Phase 3 | 33 | 21 | 2 | 6 |
| All trials | 325 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Earlier holder | 1991 to now |
| Partner Therapeutics | Acquired holder and Lead sponsor of trials | 2020 to now |
| Nobelpharma | Applicant and Lead sponsor of trials | 2020 to now |