Modality
mAb
MOA
ALKi
Target
CD19
Pathway
DDR
Endometrial CaLNPBC
Development Pipeline
Preclinical
~Dec 2013
→ ~Mar 2015
Phase 1
~Jun 2015
→ ~Sep 2016
Phase 2
~Dec 2016
→ ~Mar 2018
Phase 3
Jun 2018
→ Feb 2031
Phase 3Current
NCT05641307
1,048 pts·PBC
2018-06→2025-10·Terminated
NCT06673746
2,574 pts·PBC
2018-06→2031-02·Terminated
NCT04235357
1,943 pts·LN
2022-03→2028-06·Active
5,565 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-10-076mo agoPh3 Readout· PBC
2028-06-052.2y awayPh3 Readout· LN
2031-02-274.9y awayPh3 Readout· PBC
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P3
Termina…
P3
Termina…
P3
Active
Catalysts
Ph3 Readout
2025-10-07 · 6mo ago
PBC
Ph3 Readout
2028-06-05 · 2.2y away
LN
Ph3 Readout
2031-02-27 · 4.9y away
PBC
ActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05641307 | Phase 3 | PBC | Terminated | 1048 | FEV1 |
| NCT06673746 | Phase 3 | PBC | Terminated | 2574 | PASI75 |
| NCT04235357 | Phase 3 | LN | Active | 1943 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-8662 | Pfizer | NDA/BLA | CD19 | |
| Miriosocimab | Pfizer | Phase 1 | PARP | |
| NVS-6974 | Novartis | Preclinical | CD19 | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| DSN-5254 | Daiichi Sankyo | Phase 1 | B7-H3 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| GIL-2445 | Gilead Sciences | Phase 2/3 | PSMA |