Modality
Small Molecule
MOA
BiTE
Target
CDK2
Pathway
Notch
PNH
Development Pipeline
Preclinical
Jul 2020
→ May 2030
PreclinicalCurrent
NCT04237076
1,042 pts·PNH
2022-10→2030-05·Not yet recruiting
NCT07298677
261 pts·PNH
2020-07→2028-03·Not yet recruiting
1,303 total pts1 indication
Phase 1
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-03-202.0y awayInterim· PNH
2030-05-034.1y awayInterim· PNH
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Preclinical
Not yet…
Preclinical
Not yet…
Catalysts
Interim
2028-03-20 · 2.0y away
PNH
Interim
2030-05-03 · 4.1y away
PNH
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04237076 | Preclinical | PNH | Not yet recr... | 1042 | PFS |
| NCT07298677 | Preclinical | PNH | Not yet recr... | 261 | Safety |
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 |