Modality
mAb
MOA
TYK2i
Target
MALT1
Pathway
Epigenetic
UC
Development Pipeline
Preclinical
~Nov 2016
→ ~Feb 2018
Phase 1
~May 2018
→ ~Aug 2019
Phase 2
~Nov 2019
→ ~Feb 2021
Phase 3
~May 2021
→ ~Aug 2022
NDA/BLA
~Nov 2022
→ ~Feb 2024
Approved
May 2024
→ May 2025
ApprovedCurrent
NCT07988766
1,001 pts·UC
2024-05→2025-05·Completed
1,001 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2025-05-0611mo agoPh3 Readout· UC
Trial Timeline
Q3Q42025Q2
Approved
Complet…
Catalysts
Ph3 Readout
2025-05-06 · 11mo ago
UC
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07988766 | Approved | UC | Completed | 1001 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| Lisonaritide | Eli Lilly | Phase 3 | IL-13 | |
| MRK-2473 | Merck & Co | Phase 1/2 | Nectin-4 | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| Voxacagene | Gilead Sciences | Phase 2/3 | SOS1 | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET |