Modality
Degrader
MOA
SHP2i
Target
GPRC5D
Pathway
RNA Splicing
RA
Development Pipeline
Preclinical
~Oct 2011
→ ~Jan 2013
Phase 1
~Apr 2013
→ ~Jul 2014
Phase 2
~Oct 2014
→ ~Jan 2016
Phase 3
~Apr 2016
→ ~Jul 2017
NDA/BLA
Oct 2017
→ Dec 2025
NDA/BLACurrent
NCT03112550
295 pts·RA
2017-10→2025-12·Active
295 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-12-273mo agoPh3 Readout· RA
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
NDA/BLA
Active
Catalysts
Ph3 Readout
2025-12-27 · 3mo ago
RA
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03112550 | NDA/BLA | RA | Active | 295 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Ribotuximab | Merck & Co | Phase 2 | GPRC5D | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| Doxacagene | Sanofi | Approved | PSMA | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| GIL-9227 | Gilead Sciences | Phase 2/3 | GPRC5D | |
| VRT-1576 | Vertex Pharma | Phase 2/3 | RET | |
| Sovafutibatinib | Moderna | Approved | FcRn |