Modality
mAb
MOA
CD3xCD20
Target
TYK2
Pathway
DDR
PBC
Development Pipeline
Preclinical
~Oct 2013
→ ~Jan 2015
Phase 1
~Apr 2015
→ ~Jul 2016
Phase 2
~Oct 2016
→ ~Jan 2018
Phase 3
Apr 2018
→ Nov 2031
Phase 3Current
NCT06080677
651 pts·PBC
2018-11→2026-03·Recruiting
NCT06945071
2,281 pts·PBC
2022-05→2031-11·Recruiting
NCT04584135
275 pts·PBC
2018-04→2028-11·Active
+1 more trial
4,237 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2026-03-044w agoPh3 Readout· PBC
2028-08-062.4y awayPh3 Readout· PBC
2028-11-022.6y awayPh3 Readout· PBC
2031-11-115.6y awayPh3 Readout· PBC
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P3
Active
P3
Recruit…
P3
Active
P3
Recruit…
Catalysts
Ph3 Readout
2026-03-04 · 4w ago
PBC
Ph3 Readout
2028-08-06 · 2.4y away
PBC
Ph3 Readout
2028-11-02 · 2.6y away
PBC
Ph3 Readout
2031-11-11 · 5.6y away
PBC
RecruitingActive|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06080677 | Phase 3 | PBC | Recruiting | 651 | NT-proBNP |
| NCT06945071 | Phase 3 | PBC | Recruiting | 2281 | EFS |
| NCT04584135 | Phase 3 | PBC | Active | 275 | HAM-D |
| NCT04217582 | Phase 3 | PBC | Active | 1030 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxacilimab | Pfizer | Phase 2 | TYK2 | |
| LLY-1184 | Eli Lilly | NDA/BLA | C5 | |
| Zanuderotide | Novartis | Phase 1/2 | VEGF | |
| MRK-3732 | Merck & Co | Phase 1 | TYK2 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| Zorizanubrutinib | Novo Nordisk | Phase 1 | BTK | |
| Pexamavacamten | Daiichi Sankyo | NDA/BLA | TIGIT | |
| ITC-1028 | Intra-Cellular | Phase 2 | BCMA | |
| COR-9566 | Corcept | Approved | TYK2 | |
| Cevizasiran | Acadia Pharma | Phase 1/2 | GPRC5D |