Modality
ERT
MOA
FXIai
Target
Cl18.2
Pathway
Proteasome
HNSCCADPKD
Development Pipeline
Preclinical
~May 2016
→ ~Aug 2017
Phase 1
~Nov 2017
→ ~Feb 2019
Phase 2
May 2019
→ Sep 2030
Phase 2Current
NCT07318010
619 pts·HNSCC
2023-07→2025-02·Terminated
NCT08439999
514 pts·HNSCC
2019-05→2030-09·Terminated
1,133 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-02-181.1y agoPh2 Data· HNSCC
2030-09-104.4y awayPh2 Data· HNSCC
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P2
Termina…
P2
Termina…
Catalysts
Ph2 Data
2025-02-18 · 1.1y ago
HNSCC
Ph2 Data
2030-09-10 · 4.4y away
HNSCC
Terminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07318010 | Phase 2 | HNSCC | Terminated | 619 | VA |
| NCT08439999 | Phase 2 | HNSCC | Terminated | 514 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| JNJ-2735 | Johnson & Johnson | Phase 2/3 | Cl18.2 | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Adagrazumab | Novartis | Phase 2/3 | Cl18.2 | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D |