Modality
Multispecific
MOA
SHP2i
Target
EZH2
Pathway
mTOR
Dravet
Development Pipeline
Preclinical
~Jul 2019
→ ~Oct 2020
Phase 1
~Jan 2021
→ ~Apr 2022
Phase 2
~Jul 2022
→ ~Oct 2023
Phase 3
~Jan 2024
→ ~Apr 2025
NDA/BLA
Jul 2025
NDA/BLACurrent
NCT04740347
891 pts·Dravet
2025-07→TBD·Active
891 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-08-038mo agoEMA Filing· Dravet
Trial Timeline
Q3
NDA/BLA
Active
Catalysts
EMA Filing
2025-08-03 · 8mo ago
Dravet
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04740347 | NDA/BLA | Dravet | Active | 891 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| Doxacagene | Sanofi | Approved | PSMA | |
| DSN-2247 | Daiichi Sankyo | NDA/BLA | EZH2 | |
| VRT-1576 | Vertex Pharma | Phase 2/3 | RET | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| Daratuximab | BioMarin | Phase 1 | PRMT5 | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| Nirafotisoran | Jazz Pharma | Phase 2/3 | TROP-2 | |
| 369-4107 | Hansoh Pharma | Phase 2 | TNFα | |
| Talatapinarof | Samsung Biologics | Phase 1/2 | PCSK9 |