Modality
Gene Therapy
MOA
IL-23i
Target
SGLT2
Pathway
PD-1/PD-L1
ACCMDDEoE
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
→ Jan 2027
NDA/BLACurrent
NCT04640928
996 pts·MDD
2025-03→TBD·Active
NCT03701795
956 pts·EoE
2019-11→2027-01·Not yet recruiting
1,952 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-01-029mo awayPh3 Readout· EoE
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027
NDA/BLA
Not yet…
NDA/BLA
Active
Catalysts
Ph3 Readout
2027-01-02 · 9mo away
EoE
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04640928 | NDA/BLA | MDD | Active | 996 | PASI75 |
| NCT03701795 | NDA/BLA | EoE | Not yet recr... | 956 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| GSK-6983 | GSK | Phase 2 | ALK | |
| Motarapivir | GSK | Preclinical | AuroraA | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| Zenotapinarof | Vertex Pharma | Preclinical | CD38 | |
| SRP-3270 | Sarepta | Phase 1/2 | SGLT2 | |
| Tirarapivir | United Therapeutics | Approved | SGLT2 | |
| Bemasotorasib | Exelixis | Phase 2 | CD38 |