Modality
ERT
MOA
SHP2i
Target
FcRn
Pathway
PI3K/AKT
MCL
Development Pipeline
Preclinical
Apr 2023
→ Feb 2028
PreclinicalCurrent
NCT05963895
320 pts·MCL
2024-07→2025-02·Not yet recruiting
NCT05324898
2,721 pts·MCL
2023-04→2028-02·Not yet recruiting
3,041 total pts1 indication
Phase 1
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-02-221.1y agoInterim· MCL
2028-02-231.9y awayInterim· MCL
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028
Preclinical
Not yet…
Preclinical
Not yet…
Catalysts
Interim
2025-02-22 · 1.1y ago
MCL
Interim
2028-02-23 · 1.9y away
MCL
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05963895 | Preclinical | MCL | Not yet recr... | 320 | PFS |
| NCT05324898 | Preclinical | MCL | Not yet recr... | 2721 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Doxacagene | Sanofi | Approved | PSMA | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| VRT-1576 | Vertex Pharma | Phase 2/3 | RET | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| Daratuximab | BioMarin | Phase 1 | PRMT5 | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn |