Modality
Gene Editing
MOA
TNFi
Target
FXIa
Pathway
Fibrosis
WMASFSGS
Development Pipeline
Preclinical
~May 2016
→ ~Aug 2017
Phase 1
~Nov 2017
→ ~Feb 2019
Phase 2
~May 2019
→ ~Aug 2020
Phase 3
Nov 2020
→ Apr 2031
Phase 3Current
NCT05968711
2,849 pts·FSGS
2020-11→2031-04·Active
NCT05566825
608 pts·WM
2022-11→2025-02·Recruiting
NCT07727698
2,063 pts·WM
2023-01→TBD·Not yet recruiting
+1 more trial
5,575 total pts3 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-02-281.1y agoPh3 Readout· WM
2031-04-065.0y awayPh3 Readout· FSGS
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P3
Active
P3
Recruit…
P3
Not yet…
P3
Recruit…
Catalysts
Ph3 Readout
2025-02-28 · 1.1y ago
WM
Ph3 Readout
2031-04-06 · 5.0y away
FSGS
RecruitingActiveNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05968711 | Phase 3 | FSGS | Active | 2849 | Biomarker |
| NCT05566825 | Phase 3 | WM | Recruiting | 608 | EDSS |
| NCT07727698 | Phase 3 | WM | Not yet recr... | 2063 | NT-proBNP |
| NCT04362834 | Phase 3 | AS | Recruiting | 55 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| GIL-9142 | Gilead Sciences | Phase 1 | FXIa |