Balstilimab
As of the edition of 20 October 2026, Balstilimab is an antibody: in active development; acts on PDCD1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2028
- Kind
- Antibody
- Registered trials
- 53, 11 stopped early
- Disease areas
- Cancer; Digestive system; Urinary and reproductive; Pregnancy and women's health; Hormones; Lungs and airways
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route A because of this drug.
Companies on route A for this drug
In the product1 company is on route A because of Balstilimab.
See the 1 company on route A for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PDCD1 | Programmed cell death protein 1 | Q15116 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 0 | 0 |
| Phase 1 | 8 | 1 | 5 | 2 |
| Phase 2 | 39 | 2 | 29 | 7 |
| Phase 3 | 4 | 0 | 2 | 2 |
| All trials | 53 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Rottapharm Biotech | Lead sponsor of trials | 2021 to now |
| Targovax | Lead sponsor of trials | 2024 to now |
| Stingray Therapeutics | Lead sponsor of trials | 2024 to now |
| ImmunoGenesis | Lead sponsor of trials | 2025 to now |
| Nelum | Lead sponsor of trials | 2026 to now |
| Agenus | Lead sponsor of trials |