Modality
Small Molecule
MOA
CDK4/6i
Target
Aβ
Pathway
Cell Cycle
Bladder Ca
Development Pipeline
Preclinical
~May 2015
→ ~Aug 2016
Phase 1
~Nov 2016
→ ~Feb 2018
Phase 2
~May 2018
→ ~Aug 2019
Phase 3
~Nov 2019
→ ~Feb 2021
NDA/BLA
~May 2021
→ ~Aug 2022
Approved
Nov 2022
→ Mar 2030
ApprovedCurrent
NCT07067690
304 pts·Bladder Ca
2025-08→2030-03·Terminated
NCT04262575
105 pts·Bladder Ca
2022-11→2025-07·Recruiting
NCT06213469
2,347 pts·Bladder Ca
2024-08→2026-09·Completed
2,756 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2025-07-288mo agoPh3 Readout· Bladder Ca
2026-09-045mo awayPh3 Readout· Bladder Ca
2030-03-174.0y awayPh3 Readout· Bladder Ca
Trial Timeline
Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Recruit…
Approved
Complet…
Approved
Termina…
Catalysts
Ph3 Readout
2025-07-28 · 8mo ago
Bladder Ca
Ph3 Readout
2026-09-04 · 5mo away
Bladder Ca
Ph3 Readout
2030-03-17 · 4.0y away
Bladder Ca
RecruitingCompletedTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07067690 | Approved | Bladder Ca | Terminated | 304 | PASI75 |
| NCT04262575 | Approved | Bladder Ca | Recruiting | 105 | BodyWt |
| NCT06213469 | Approved | Bladder Ca | Completed | 2347 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| RHH-1969 | Roche | Approved | BET | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Bemalucimab | Bristol-Myers Squibb | Phase 1/2 | Aβ | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ |