Modality
siRNA
MOA
VEGFi
Target
CD38
Pathway
JAK/STAT
CFNMOSDLN
Development Pipeline
Preclinical
~May 2019
→ ~Aug 2020
Phase 1
~Nov 2020
→ ~Feb 2022
Phase 2
~May 2022
→ ~Aug 2023
Phase 3
~Nov 2023
→ ~Feb 2025
NDA/BLA
May 2025
→ Aug 2028
NDA/BLACurrent
NCT08065404
1,961 pts·CF
2025-05→TBD·Completed
NCT06144255
282 pts·NMOSD
2025-08→2028-08·Terminated
2,243 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-08-212.4y awayPh3 Readout· NMOSD
Trial Timeline
Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
NDA/BLA
Complet…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2028-08-21 · 2.4y away
NMOSD
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08065404 | NDA/BLA | CF | Completed | 1961 | SRI-4 |
| NCT06144255 | NDA/BLA | NMOSD | Terminated | 282 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| MRK-5413 | Merck & Co | Phase 1 | GLP-1R | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| Ceviderotide | Novo Nordisk | Preclinical | IL-13 | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| Ivosotorasib | Vertex Pharma | Preclinical | CD38 |