Modality
ASO
MOA
PD-L1i
Target
B7-H3
Pathway
Innate Imm
Schizophrenia
Development Pipeline
Preclinical
~Aug 2013
→ ~Nov 2014
Phase 1
~Feb 2015
→ ~May 2016
Phase 2
~Aug 2016
→ ~Nov 2017
Phase 3
~Feb 2018
→ ~May 2019
NDA/BLA
~Aug 2019
→ ~Nov 2020
Approved
Feb 2021
→ Nov 2026
ApprovedCurrent
NCT07796288
284 pts·Schizophrenia
2024-03→2026-11·Not yet recruiting
NCT05228334
2,639 pts·Schizophrenia
2021-02→TBD·Not yet recruiting
2,923 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2026-11-188mo awayPh3 Readout· Schizophrenia
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
Approved
Not yet…
Approved
Not yet…
Catalysts
Ph3 Readout
2026-11-18 · 8mo away
Schizophrenia
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07796288 | Approved | Schizophrenia | Not yet recr... | 284 | SRI-4 |
| NCT05228334 | Approved | Schizophrenia | Not yet recr... | 2639 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 | |
| NVO-7872 | Novo Nordisk | NDA/BLA | B7-H3 | |
| Nirafutibatinib | Bayer | Phase 2 | WRN |