Modality
Fusion Protein
MOA
FGFRi
Target
USP1
Pathway
Hedgehog
LGS
Development Pipeline
Preclinical
~May 2017
→ ~Aug 2018
Phase 1
~Nov 2018
→ ~Feb 2020
Phase 2
~May 2020
→ ~Aug 2021
Phase 3
~Nov 2021
→ ~Feb 2023
NDA/BLA
~May 2023
→ ~Aug 2024
Approved
Nov 2024
→ Jan 2029
ApprovedCurrent
NCT04852232
832 pts·LGS
2024-11→2029-01·Recruiting
832 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2026-02-092mo agoNDA· LGS
2029-01-092.8y awayPh3 Readout· LGS
Trial Timeline
2025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029
Approved
Recruit…
Catalysts
NDA
2026-02-09 · 2mo ago
LGS
Ph3 Readout
2029-01-09 · 2.8y away
LGS
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04852232 | Approved | LGS | Recruiting | 832 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-9749 | Eli Lilly | Phase 3 | C5 | |
| LLY-1956 | Eli Lilly | Phase 1/2 | BCMA | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| SRP-9822 | Sarepta | Phase 3 | SOS1 | |
| Rimainavolisib | Illumina | Phase 2 | PD-1 | |
| Elrainavolisib | Roivant Sciences | Preclinical | Nectin-4 | |
| Tezesotorasib | Enliven | Phase 2 | USP1 | |
| ETN-5063 | 89bio | Phase 1/2 | USP1 | |
| VYG-2970 | Voyager | Phase 3 | JAK1 | |
| Capirelsin | Y-mAbs | Phase 2 | FLT3 |