Modality
Multispecific
MOA
CFTRmod
Target
KRASG12C
Pathway
Proteasome
Urothelial CaCeliac
Development Pipeline
Preclinical
~May 2019
→ ~Aug 2020
Phase 1
Nov 2020
→ Oct 2025
Phase 1Current
NCT08631751
746 pts·Urothelial Ca
2020-11→2025-07·Completed
NCT05662021
1,146 pts·Celiac
2024-03→2025-10·Terminated
1,892 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-07-268mo agoPh2 Data· Urothelial Ca
2025-10-245mo agoPh2 Data· Celiac
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
P1/2
Complet…
P1/2
Termina…
Catalysts
Ph2 Data
2025-07-26 · 8mo ago
Urothelial Ca
Ph2 Data
2025-10-24 · 5mo ago
Celiac
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08631751 | Phase 1/2 | Urothelial Ca | Completed | 746 | FEV1 |
| NCT05662021 | Phase 1/2 | Celiac | Terminated | 1146 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-179 | Johnson & Johnson | Approved | KRASG12C | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| Doxarapivir | Bristol-Myers Squibb | Phase 3 | KRASG12C | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| REG-8074 | Regeneron | Phase 2/3 | KRASG12C | |
| VRT-1891 | Vertex Pharma | Phase 1 | KRASG12C | |
| Darafutibatinib | BioNTech | Preclinical | PRMT5 | |
| ALN-8757 | Alnylam | Preclinical | TIGIT |