Modality
Radioligand
MOA
C5i
Target
CDK2
Pathway
Epigenetic
SMA
Development Pipeline
Preclinical
~Mar 2018
→ ~Jun 2019
Phase 1
Sep 2019
→ Sep 2030
Phase 1Current
NCT07806332
688 pts·SMA
2019-09→2030-09·Completed
688 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2030-09-184.5y awayInterim· SMA
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P1
Complet…
Catalysts
Interim
2030-09-18 · 4.5y away
SMA
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07806332 | Phase 1 | SMA | Completed | 688 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| DSN-2247 | Daiichi Sankyo | NDA/BLA | EZH2 | |
| 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 | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 |