Modality
Nanobody
MOA
BiTE
Target
CDK2
Pathway
Ferroptosis
Prostate CaALL
Development Pipeline
Preclinical
~Nov 2013
→ ~Feb 2015
Phase 1
~May 2015
→ ~Aug 2016
Phase 2
~Nov 2016
→ ~Feb 2018
Phase 3
~May 2018
→ ~Aug 2019
NDA/BLA
Nov 2019
→ Oct 2027
NDA/BLACurrent
NCT06055330
2,359 pts·Prostate Ca
2019-11→2027-10·Active
2,359 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-10-101.5y awayPh3 Readout· Prostate Ca
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
NDA/BLA
Active
Catalysts
Ph3 Readout
2027-10-10 · 1.5y away
Prostate Ca
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06055330 | NDA/BLA | Prostate Ca | Active | 2359 | UPCR |
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 |