Modality
Peptide
MOA
PD-L1i
Target
CD47
Pathway
PI3K/AKT
FLWilms
Development Pipeline
Preclinical
~Jan 2018
→ ~Apr 2019
Phase 1
~Jul 2019
→ ~Oct 2020
Phase 2
~Jan 2021
→ ~Apr 2022
Phase 3
~Jul 2022
→ ~Oct 2023
NDA/BLA
~Jan 2024
→ ~Apr 2025
Approved
Jul 2025
→ Jan 2029
ApprovedCurrent
NCT03139099
2,338 pts·Wilms
2025-07→2027-07·Recruiting
NCT04977659
286 pts·Wilms
2025-10→2029-01·Active
2,624 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2027-07-261.3y awayPh3 Readout· Wilms
2029-01-082.8y awayPh3 Readout· Wilms
Trial Timeline
Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029
Approved
Recruit…
Approved
Active
Catalysts
Ph3 Readout
2027-07-26 · 1.3y away
Wilms
Ph3 Readout
2029-01-08 · 2.8y away
Wilms
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03139099 | Approved | Wilms | Recruiting | 2338 | DAS28 |
| NCT04977659 | Approved | Wilms | Active | 286 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| GSK-4334 | GSK | Preclinical | CD47 | |
| Nirafutibatinib | Bayer | Phase 2 | WRN | |
| Motainavolisib | Amgen | NDA/BLA | CD47 | |
| BNT-8090 | BioNTech | Phase 2 | AuroraA | |
| Miriglumide | Alnylam | Phase 3 | CD3 | |
| BMR-1165 | BioMarin | Phase 2 | CD47 |