Modality
Cell Therapy
MOA
CDK2i
Target
KRASG12D
Pathway
Innate Imm
CFSchizophreniaCML
Development Pipeline
Preclinical
~Sep 2013
→ ~Dec 2014
Phase 1
~Mar 2015
→ ~Jun 2016
Phase 2
~Sep 2016
→ ~Dec 2017
Phase 3
~Mar 2018
→ ~Jun 2019
NDA/BLA
Sep 2019
→ Nov 2028
NDA/BLACurrent
NCT03106157
1,879 pts·Schizophrenia
2019-11→TBD·Active
NCT08093463
2,809 pts·Schizophrenia
2019-09→2028-11·Terminated
4,688 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-11-172.6y awayPh3 Readout· Schizophrenia
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
NDA/BLA
Termina…
NDA/BLA
Active
Catalysts
Ph3 Readout
2028-11-17 · 2.6y away
Schizophrenia
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03106157 | NDA/BLA | Schizophrenia | Active | 1879 | CfB |
| NCT08093463 | NDA/BLA | Schizophrenia | Terminated | 2809 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Mavuglumide | Bayer | Approved | GLP-1R |