Modality
Gene Editing
MOA
CDK4/6i
Target
MET
Pathway
Lipid Met
PBC
Development Pipeline
Preclinical
~Apr 2015
→ ~Jul 2016
Phase 1
~Oct 2016
→ ~Jan 2018
Phase 2
~Apr 2018
→ ~Jul 2019
Phase 3
Oct 2019
→ Nov 2030
Phase 3Current
NCT03335298
588 pts·PBC
2023-01→2029-07·Recruiting
NCT05787491
1,504 pts·PBC
2019-10→2030-11·Completed
NCT06091541
2,797 pts·PBC
2021-08→2025-01·Terminated
4,889 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-01-221.2y agoPh3 Readout· PBC
2029-07-173.3y awayPh3 Readout· PBC
2030-11-144.6y awayPh3 Readout· PBC
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Complet…
P3
Termina…
P3
Recruit…
Catalysts
Ph3 Readout
2025-01-22 · 1.2y ago
PBC
Ph3 Readout
2029-07-17 · 3.3y away
PBC
Ph3 Readout
2030-11-14 · 4.6y away
PBC
RecruitingCompletedTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03335298 | Phase 3 | PBC | Recruiting | 588 | Biomarker |
| NCT05787491 | Phase 3 | PBC | Completed | 1504 | MRD |
| NCT06091541 | Phase 3 | PBC | Terminated | 2797 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| RHH-1969 | Roche | Approved | BET | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| SNY-5783 | Sanofi | Phase 1/2 | MET | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET | |
| VRT-5441 | Vertex Pharma | Phase 3 | GLP-1R | |
| Adagracapivasertib | BeiGene | NDA/BLA | BET |