Modality
Gene Therapy
MOA
IL-13i
Target
PI3Kα
Pathway
Proteasome
SchizophreniaObesity
Development Pipeline
Preclinical
~Nov 2013
→ ~Feb 2015
Phase 1
~May 2015
→ ~Aug 2016
Phase 2
~Nov 2016
→ ~Feb 2018
Phase 3
~May 2018
→ ~Aug 2019
NDA/BLA
Nov 2019
→ Mar 2027
NDA/BLACurrent
NCT05341609
2,817 pts·Schizophrenia
2019-11→2027-03·Recruiting
2,817 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-03-2212mo awayPh3 Readout· Schizophrenia
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2027-03-22 · 12mo away
Schizophrenia
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05341609 | NDA/BLA | Schizophrenia | Recruiting | 2817 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-7975 | Roche | Phase 3 | FXIa | |
| NVS-8902 | Novartis | Preclinical | TROP-2 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα |