Modality
Cell Therapy
MOA
BiTE
Target
IL-23
Pathway
Fibrosis
Schizophrenia
Development Pipeline
Preclinical
~Jun 2017
→ ~Sep 2018
Phase 1
~Dec 2018
→ ~Mar 2020
Phase 2
~Jun 2020
→ ~Sep 2021
Phase 3
~Dec 2021
→ ~Mar 2023
NDA/BLA
Jun 2023
→ Dec 2031
NDA/BLACurrent
NCT04344906
1,172 pts·Schizophrenia
2023-06→2031-12·Recruiting
1,172 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-11-168mo awayFast Track· Schizophrenia
2031-12-185.7y awayPh3 Readout· Schizophrenia
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Recruit…
Catalysts
Fast Track
2026-11-16 · 8mo away
Schizophrenia
Ph3 Readout
2031-12-18 · 5.7y away
Schizophrenia
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04344906 | NDA/BLA | Schizophrenia | Recruiting | 1172 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| DSN-6862 | Daiichi Sankyo | Preclinical | IL-23 | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 | |
| Fixalucimab | Innovent Bio | Phase 1/2 | IL-23 |