Modality
Degrader
MOA
BiTE
Target
CDK2
Pathway
T-cell
RB
Development Pipeline
Preclinical
~Jul 2010
→ ~Oct 2011
Phase 1
~Jan 2012
→ ~Apr 2013
Phase 2
~Jul 2013
→ ~Oct 2014
Phase 3
~Jan 2015
→ ~Apr 2016
NDA/BLA
~Jul 2016
→ ~Oct 2017
Approved
Jan 2018
→ Oct 2027
ApprovedCurrent
NCT03608358
468 pts·RB
2018-01→2027-10·Terminated
468 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2027-10-031.5y awayPh3 Readout· RB
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
Approved
Termina…
Catalysts
Ph3 Readout
2027-10-03 · 1.5y away
RB
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03608358 | Approved | RB | Terminated | 468 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 |