Modality
ADC
MOA
PRMT5i
Target
CDK4/6
Pathway
Apoptosis
Urothelial Ca
Development Pipeline
Preclinical
~Jul 2016
→ ~Oct 2017
Phase 1
~Jan 2018
→ ~Apr 2019
Phase 2
Jul 2019
→ Sep 2029
Phase 2Current
NCT07079194
1,009 pts·Urothelial Ca
2024-04→2026-09·Active
NCT07107912
422 pts·Urothelial Ca
2019-07→2029-09·Active
1,431 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-09-166mo awayPh2 Data· Urothelial Ca
2029-09-023.4y awayPh2 Data· Urothelial Ca
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P2
Active
P2
Active
Catalysts
Ph2 Data
2026-09-16 · 6mo away
Urothelial Ca
Ph2 Data
2029-09-02 · 3.4y away
Urothelial Ca
Active|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07079194 | Phase 2 | Urothelial Ca | Active | 1009 | CfB |
| NCT07107912 | Phase 2 | Urothelial Ca | Active | 422 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| GIL-9142 | Gilead Sciences | Phase 1 | FXIa | |
| Semainavolisib | Gilead Sciences | Phase 2 | PARP | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| VRT-1891 | Vertex Pharma | Phase 1 | KRASG12C |