Modality
mRNA
MOA
HER2
Target
CDK2
Pathway
RNA Splicing
Prostate CaALL
Development Pipeline
Preclinical
~Mar 2011
→ ~Jun 2012
Phase 1
~Sep 2012
→ ~Dec 2013
Phase 2
~Mar 2014
→ ~Jun 2015
Phase 3
~Sep 2015
→ ~Dec 2016
NDA/BLA
~Mar 2017
→ ~Jun 2018
Approved
Sep 2018
→ Nov 2031
ApprovedCurrent
NCT05440895
777 pts·Prostate Ca
2024-10→2028-09·Terminated
NCT08954740
2,718 pts·Prostate Ca
2018-10→2030-06·Terminated
NCT08991045
2,372 pts·ALL
2020-12→2031-11·Terminated
+1 more trial
6,543 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2028-09-212.5y awayPh3 Readout· Prostate Ca
2029-02-072.9y awayPh3 Readout· ALL
2030-06-174.2y awayPh3 Readout· Prostate Ca
2031-11-185.6y awayPh3 Readout· ALL
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Not yet…
Approved
Termina…
Approved
Termina…
Approved
Termina…
Catalysts
Ph3 Readout
2028-09-21 · 2.5y away
Prostate Ca
Ph3 Readout
2029-02-07 · 2.9y away
ALL
Ph3 Readout
2030-06-17 · 4.2y away
Prostate Ca
Ph3 Readout
2031-11-18 · 5.6y away
ALL
TerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05440895 | Approved | Prostate Ca | Terminated | 777 | EFS |
| NCT08954740 | Approved | Prostate Ca | Terminated | 2718 | Safety |
| NCT08991045 | Approved | ALL | Terminated | 2372 | eGFR |
| NCT05963392 | Approved | ALL | Not yet recr... | 676 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 |