Modality
ERT
MOA
CDK2i
Target
FXIa
Pathway
Notch
HCC
Development Pipeline
Preclinical
~Jul 2014
→ ~Oct 2015
Phase 1
~Jan 2016
→ ~Apr 2017
Phase 2
Jul 2017
→ Sep 2029
Phase 2Current
NCT04553053
1,349 pts·HCC
2021-06→2026-08·Recruiting
NCT08044670
941 pts·HCC
2017-07→2029-09·Completed
2,290 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-08-185mo awayPh3 Readout· HCC
2029-09-213.5y awayPh3 Readout· HCC
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P2/3
Complet…
P2/3
Recruit…
Catalysts
Ph3 Readout
2026-08-18 · 5mo away
HCC
Ph3 Readout
2029-09-21 · 3.5y away
HCC
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04553053 | Phase 2/3 | HCC | Recruiting | 1349 | DAS28 |
| NCT08044670 | Phase 2/3 | HCC | Completed | 941 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A |