Modality
Cell Therapy
MOA
BTKi
Target
SHP2
Pathway
Hedgehog
GARSVSCD
Development Pipeline
Preclinical
~Dec 2021
→ ~Mar 2023
Phase 1
Jun 2023
→ Jan 2030
Phase 1Current
NCT05448992
359 pts·GA
2023-06→2030-01·Completed
NCT05314781
2,840 pts·GA
2025-07→2025-11·Not yet recruiting
3,199 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-11-234mo agoInterim· GA
2026-07-053mo awayPh1 Dose Esc· RSV
2030-01-253.8y awayInterim· GA
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030
P1
Complet…
P1
Not yet…
Catalysts
Interim
2025-11-23 · 4mo ago
GA
Ph1 Dose Esc
2026-07-05 · 3mo away
RSV
Interim
2030-01-25 · 3.8y away
GA
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05448992 | Phase 1 | GA | Completed | 359 | NT-proBNP |
| NCT05314781 | Phase 1 | GA | Not yet recr... | 2840 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| NVO-7872 | Novo Nordisk | NDA/BLA | B7-H3 | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| Zanumavacamten | GSK | Phase 2/3 | TROP-2 | |
| TAK-2403 | Takeda | Phase 2 | WEE1 | |
| Lisorapivir | Takeda | Preclinical | WRN |