Modality
Cell Therapy
MOA
Menini
Target
USP1
Pathway
Cell Cycle
PTSD
Development Pipeline
Preclinical
~May 2016
→ ~Aug 2017
Phase 1
Nov 2017
→ Sep 2027
Phase 1Current
NCT06223259
2,833 pts·PTSD
2017-11→2026-07·Active
NCT08380557
943 pts·PTSD
2022-03→2027-09·Completed
3,776 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-07-224mo awayInterim· PTSD
2027-09-181.5y awayInterim· PTSD
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
P1
Active
P1
Complet…
Catalysts
Interim
2026-07-22 · 4mo away
PTSD
Interim
2027-09-18 · 1.5y away
PTSD
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06223259 | Phase 1 | PTSD | Active | 2833 | UPCR |
| NCT08380557 | Phase 1 | PTSD | Completed | 943 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| Olpafutibatinib | Immunocore | Approved | SMN2 | |
| Tezesotorasib | Enliven | Phase 2 | USP1 | |
| ETN-5063 | 89bio | Phase 1/2 | USP1 | |
| TXG-6755 | 10x Genomics | Approved | CD123 | |
| Zoricapivasertib | CSL Limited | Phase 2 | HER2 | |
| Fixatapinarof | Jiangsu Hengrui | Preclinical | PLK4 |