Modality
ADC
MOA
PCSK9i
Target
FXIa
Pathway
T-cell
CTCLFabryHS
Development Pipeline
Preclinical
~Jan 2017
→ ~Apr 2018
Phase 1
~Jul 2018
→ ~Oct 2019
Phase 2
Jan 2020
→ Aug 2027
Phase 2Current
NCT03393431
2,361 pts·CTCL
2020-01→2027-08·Recruiting
2,361 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-09-236mo awayEnrollment Complete· CTCL
2027-08-151.4y awayPh3 Readout· CTCL
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
P2/3
Recruit…
Catalysts
Enrollment Complete
2026-09-23 · 6mo away
CTCL
Ph3 Readout
2027-08-15 · 1.4y away
CTCL
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03393431 | Phase 2/3 | CTCL | Recruiting | 2361 | LiverFat |
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 | |
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Rimaosocimab | Amgen | Preclinical | FXIa |