Modality
Radioligand
MOA
KRASG12Ci
Target
CDK2
Pathway
RNA Splicing
MDS
Development Pipeline
Preclinical
~Oct 2014
→ ~Jan 2016
Phase 1
~Apr 2016
→ ~Jul 2017
Phase 2
~Oct 2017
→ ~Jan 2019
Phase 3
~Apr 2019
→ ~Jul 2020
NDA/BLA
Oct 2020
→ Aug 2029
NDA/BLACurrent
NCT07239462
2,245 pts·MDS
2020-10→2029-08·Not yet recruiting
2,245 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-08-153.4y awayPh3 Readout· MDS
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2029-08-15 · 3.4y away
MDS
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07239462 | NDA/BLA | MDS | Not yet recr... | 2245 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| Lisolucimab | Novartis | Approved | CD20 | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 |