Modality
Small Molecule
MOA
PD-L1i
Target
B7-H3
Pathway
Fibrosis
UCMyelofibrosis
Development Pipeline
Preclinical
~Jun 2013
→ ~Sep 2014
Phase 1
~Dec 2014
→ ~Mar 2016
Phase 2
~Jun 2016
→ ~Sep 2017
Phase 3
~Dec 2017
→ ~Mar 2019
NDA/BLA
Jun 2019
→ Nov 2026
NDA/BLACurrent
NCT06736444
1,866 pts·UC
2019-06→2026-11·Active
1,866 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-11-097mo awayPh3 Readout· UC
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
NDA/BLA
Active
Catalysts
Ph3 Readout
2026-11-09 · 7mo away
UC
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06736444 | NDA/BLA | UC | Active | 1866 | CfB |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 | |
| NVO-7872 | Novo Nordisk | NDA/BLA | B7-H3 | |
| Nirafutibatinib | Bayer | Phase 2 | WRN | |
| DSN-5254 | Daiichi Sankyo | Phase 1 | B7-H3 |