Modality
ASO
MOA
PD-1i
Target
CDK2
Pathway
Proteasome
CF
Development Pipeline
Preclinical
~Jan 2017
→ ~Apr 2018
Phase 1
~Jul 2018
→ ~Oct 2019
Phase 2
Jan 2020
→ Feb 2027
Phase 2Current
NCT04299458
1,505 pts·CF
2020-01→2027-02·Terminated
1,505 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-02-2511mo awayPh3 Readout· CF
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
P2/3
Termina…
Catalysts
Ph3 Readout
2027-02-25 · 11mo away
CF
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04299458 | Phase 2/3 | CF | Terminated | 1505 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| GSK-7987 | GSK | Phase 3 | MDM2 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 | |
| ALN-3284 | Alnylam | Phase 2/3 | CDK2 |