Modality
ASO
MOA
KRASG12Ci
Target
BTK
Pathway
Amyloid
HNSCC
Development Pipeline
Preclinical
~Jan 2018
→ ~Apr 2019
Phase 1
~Jul 2019
→ ~Oct 2020
Phase 2
Jan 2021
→ Oct 2031
Phase 2Current
NCT05250385
2,115 pts·HNSCC
2021-11→2030-11·Completed
NCT03156241
2,496 pts·HNSCC
2021-01→2031-10·Active
4,611 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-03-221w agoOrphan Drug· HNSCC
2030-11-094.6y awayPh3 Readout· HNSCC
2031-10-145.5y awayPh3 Readout· HNSCC
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P2/3
Active
P2/3
Complet…
Catalysts
Orphan Drug
2026-03-22 · 1w ago
HNSCC
Ph3 Readout
2030-11-09 · 4.6y away
HNSCC
Ph3 Readout
2031-10-14 · 5.5y away
HNSCC
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05250385 | Phase 2/3 | HNSCC | Completed | 2115 | DOR |
| NCT03156241 | Phase 2/3 | HNSCC | Active | 2496 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Lisolucimab | Novartis | Approved | CD20 | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| Zorizanubrutinib | Novo Nordisk | Phase 1 | BTK | |
| ALN-6288 | Alnylam | Approved | LAG-3 | |
| BMR-9762 | BioMarin | Phase 3 | Aβ |