Modality
Degrader
MOA
PD-1i
Target
CDK2
Pathway
Fibrosis
PNH
Development Pipeline
Preclinical
~Jul 2015
→ ~Oct 2016
Phase 1
Jan 2017
→ Dec 2031
Phase 1Current
NCT06432637
2,785 pts·PNH
2022-03→2030-01·Completed
NCT08741480
933 pts·PNH
2017-01→2031-12·Completed
3,718 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2030-01-183.8y awayInterim· PNH
2031-12-265.7y awayInterim· PNH
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P1
Complet…
P1
Complet…
Catalysts
Interim
2030-01-18 · 3.8y away
PNH
Interim
2031-12-26 · 5.7y away
PNH
Completed|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06432637 | Phase 1 | PNH | Completed | 2785 | PASI75 |
| NCT08741480 | Phase 1 | PNH | Completed | 933 | OS |
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 | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 |