Modality
ERT
MOA
MALT1i
Target
CDK2
Pathway
Wnt
AMLBladder CaAsthma
Development Pipeline
Preclinical
~Feb 2010
→ ~May 2011
Phase 1
~Aug 2011
→ ~Nov 2012
Phase 2
~Feb 2013
→ ~May 2014
Phase 3
~Aug 2014
→ ~Nov 2015
NDA/BLA
~Feb 2016
→ ~May 2017
Approved
Aug 2017
ApprovedCurrent
NCT07367541
2,942 pts·AML
2017-08→TBD·Not yet recruiting
2,942 total pts1 indication
CompletedCurrentUpcoming
Trial Timeline
Approved
Not yet…
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07367541 | Approved | AML | Not yet recr... | 2942 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| JNJ-2735 | Johnson & Johnson | Phase 2/3 | Cl18.2 | |
| Riboinavolisib | Johnson & Johnson | Phase 2/3 | GLP-1R | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| ABB-8985 | AbbVie | Phase 2 | CD20 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 |