Modality
Gene Therapy
MOA
SHP2i
Target
FXIa
Pathway
Apoptosis
CSU
Development Pipeline
Preclinical
~May 2014
→ ~Aug 2015
Phase 1
~Nov 2015
→ ~Feb 2017
Phase 2
May 2017
→ Jan 2028
Phase 2Current
NCT04082026
1,531 pts·CSU
2017-05→2028-01·Completed
NCT06496648
669 pts·CSU
2019-09→2027-03·Recruiting
2,200 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-11-035mo agoEnrollment Complete· CSU
2027-03-1211mo awayPh3 Readout· CSU
2028-01-041.8y awayPh3 Readout· CSU
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028
P2/3
Complet…
P2/3
Recruit…
Catalysts
Enrollment Complete
2025-11-03 · 5mo ago
CSU
Ph3 Readout
2027-03-12 · 11mo away
CSU
Ph3 Readout
2028-01-04 · 1.8y away
CSU
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04082026 | Phase 2/3 | CSU | Completed | 1531 | PASI75 |
| NCT06496648 | Phase 2/3 | CSU | Recruiting | 669 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| Doxacagene | Sanofi | Approved | PSMA | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| GIL-9142 | Gilead Sciences | Phase 1 | FXIa | |
| VRT-1576 | Vertex Pharma | Phase 2/3 | RET |