Modality
ERT
MOA
PD-L1i
Target
MALT1
Pathway
Hedgehog
MG
Development Pipeline
Preclinical
~Apr 2013
→ ~Jul 2014
Phase 1
~Oct 2014
→ ~Jan 2016
Phase 2
~Apr 2016
→ ~Jul 2017
Phase 3
Oct 2017
→ Oct 2026
Phase 3Current
NCT05179171
2,683 pts·MG
2017-10→2026-10·Terminated
2,683 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-10-157mo awayPh3 Readout· MG
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
P3
Termina…
Catalysts
Ph3 Readout
2026-10-15 · 7mo away
MG
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05179171 | Phase 3 | MG | Terminated | 2683 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| Nirafutibatinib | Bayer | Phase 2 | WRN | |
| Motainavolisib | Amgen | NDA/BLA | CD47 | |
| BNT-8090 | BioNTech | Phase 2 | AuroraA | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 |