Serplulimab
As of the edition of 20 October 2026, Serplulimab is an antibody: marketed, first approved in 2025 (EU); acts on PDCD1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Antibody
- Brand name
- Hetronifly
- First approved
- 3 February 2025 (EU)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Accord Healthcare
- Registered trials
- 145, 3 stopped early
- Disease areas
- Cancer; Digestive system; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Skin and connective tissue
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PDCD1 | Programmed cell death protein 1 | Q15116 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 0 | 6 | 0 |
| Phase 1 | 9 | 1 | 5 | 0 |
| Phase 2 | 104 | 1 | 72 | 1 |
| Phase 3 | 20 | 2 | 12 | 2 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 145 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Accord Healthcare | Applicant | 2025 to now |