Modality
ERT
MOA
PI3Ki
Target
SGLT2
Pathway
Innate Imm
PBCPSPMCC
Development Pipeline
Preclinical
~Apr 2020
→ ~Jul 2021
Phase 1
~Oct 2021
→ ~Jan 2023
Phase 2
Apr 2023
→ Aug 2027
Phase 2Current
NCT03356649
2,252 pts·PBC
2023-04→2025-02·Active
NCT03331938
1,943 pts·MCC
2024-01→2027-08·Not yet recruiting
4,195 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-02-171.1y agoPh3 Readout· PBC
2027-08-241.4y awayPh3 Readout· MCC
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3
P2/3
Active
P2/3
Not yet…
Catalysts
Ph3 Readout
2025-02-17 · 1.1y ago
PBC
Ph3 Readout
2027-08-24 · 1.4y away
MCC
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03356649 | Phase 2/3 | PBC | Active | 2252 | EASI-75 |
| NCT03331938 | Phase 2/3 | MCC | Not yet recr... | 1943 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| SRP-3270 | Sarepta | Phase 1/2 | SGLT2 | |
| Tirarapivir | United Therapeutics | Approved | SGLT2 | |
| Pexanaritide | Innovent Bio | Preclinical | SGLT2 |