Modality
Peptide
MOA
WEE1i
Target
PI3Kα
Pathway
PD-1/PD-L1
T2DNMOSDLN
Development Pipeline
Preclinical
~Nov 2017
→ ~Feb 2019
Phase 1
~May 2019
→ ~Aug 2020
Phase 2
~Nov 2020
→ ~Feb 2022
Phase 3
~May 2022
→ ~Aug 2023
NDA/BLA
Nov 2023
→ Jan 2026
NDA/BLACurrent
NCT06447990
1,178 pts·NMOSD
2023-11→2026-01·Completed
1,178 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-01-152mo agoPh3 Readout· NMOSD
Trial Timeline
2024Q2Q3Q42025Q2Q3Q42026
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2026-01-15 · 2mo ago
NMOSD
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06447990 | NDA/BLA | NMOSD | Completed | 1178 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| JNJ-8637 | Johnson & Johnson | NDA/BLA | CD20 | |
| MRK-853 | Merck & Co | Phase 1 | PRMT5 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Doxafotisoran | Daiichi Sankyo | Phase 1 | Cl18.2 | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| Talatuximab | Samsung Biologics | Preclinical | CD3 | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα |