Modality
Gene Therapy
MOA
SHP2i
Target
GPRC5D
Pathway
Complement
MCCCSU
Development Pipeline
Preclinical
~Jul 2013
→ ~Oct 2014
Phase 1
~Jan 2015
→ ~Apr 2016
Phase 2
~Jul 2016
→ ~Oct 2017
Phase 3
Jan 2018
→ Jun 2031
Phase 3Current
NCT07218781
2,077 pts·CSU
2021-07→2030-01·Recruiting
NCT03059802
2,137 pts·CSU
2025-07→2028-06·Active
NCT03075893
554 pts·CSU
2018-01→2031-06·Recruiting
4,768 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2028-06-022.2y awayPh3 Readout· CSU
2030-01-113.8y awayPh3 Readout· CSU
2031-06-075.2y awayPh3 Readout· CSU
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P3
Recruit…
P3
Recruit…
P3
Active
Catalysts
Ph3 Readout
2028-06-02 · 2.2y away
CSU
Ph3 Readout
2030-01-11 · 3.8y away
CSU
Ph3 Readout
2031-06-07 · 5.2y away
CSU
RecruitingActive|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07218781 | Phase 3 | CSU | Recruiting | 2077 | CfB |
| NCT03059802 | Phase 3 | CSU | Active | 2137 | VA |
| NCT03075893 | Phase 3 | CSU | Recruiting | 554 | SeizFreq |
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 |