Modality
Gene Editing
MOA
ALKi
Target
CDK2
Pathway
Epigenetic
PsoriasisSLEProstate Ca
Development Pipeline
Preclinical
~Aug 2013
→ ~Nov 2014
Phase 1
~Feb 2015
→ ~May 2016
Phase 2
~Aug 2016
→ ~Nov 2017
Phase 3
Feb 2018
→ Mar 2029
Phase 3Current
NCT04517251
851 pts·Psoriasis
2022-10→TBD·Recruiting
NCT08451318
2,931 pts·Psoriasis
2024-01→2029-03·Not yet recruiting
NCT07425353
987 pts·Psoriasis
2022-03→TBD·Recruiting
+1 more trial
7,024 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-01-251.2y agoPh3 Readout· Prostate Ca
2029-03-092.9y awayPh3 Readout· Psoriasis
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
P3
Not yet…
P3
Recruit…
P3
Recruit…
P3
Not yet…
Catalysts
Ph3 Readout
2025-01-25 · 1.2y ago
Prostate Ca
Ph3 Readout
2029-03-09 · 2.9y away
Psoriasis
RecruitingNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04517251 | Phase 3 | Psoriasis | Recruiting | 851 | 6MWD |
| NCT08451318 | Phase 3 | Psoriasis | Not yet recr... | 2931 | CfB |
| NCT07425353 | Phase 3 | Psoriasis | Recruiting | 987 | PFS |
| NCT08866433 | Phase 3 | Prostate Ca | Not yet recr... | 2255 | FEV1 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| Miriosocimab | Pfizer | Phase 1 | PARP | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| DSN-5254 | Daiichi Sankyo | Phase 1 | B7-H3 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| AMG-415 | Amgen | Phase 1 | CDK2 |