Modality
mRNA
MOA
STINGag
Target
CFTR
Pathway
Incretin
NASHNMOSD
Development Pipeline
Preclinical
~Jun 2019
→ ~Sep 2020
Phase 1
~Dec 2020
→ ~Mar 2022
Phase 2
Jun 2022
→ Dec 2031
Phase 2Current
NCT04102544
1,709 pts·NASH
2023-02→2028-11·Recruiting
NCT07184548
1,329 pts·NMOSD
2022-06→2031-12·Active
3,038 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-11-222.6y awayPh3 Readout· NASH
2031-12-205.7y awayPh3 Readout· NMOSD
Trial Timeline
Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P2/3
Active
P2/3
Recruit…
Catalysts
Ph3 Readout
2028-11-22 · 2.6y away
NASH
Ph3 Readout
2031-12-20 · 5.7y away
NMOSD
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04102544 | Phase 2/3 | NASH | Recruiting | 1709 | HbA1c |
| NCT07184548 | Phase 2/3 | NMOSD | Active | 1329 | DAS28 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| RHH-5389 | Roche | Preclinical | RET | |
| Datoglumide | AbbVie | Approved | CFTR | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| SNY-4496 | Sanofi | Phase 2/3 | CD3 | |
| SNY-5783 | Sanofi | Phase 1/2 | MET | |
| DSN-1421 | Daiichi Sankyo | Phase 3 | Nectin-4 | |
| GIL-4361 | Gilead Sciences | Preclinical | PCSK9 | |
| Sovarelsin | BioMarin | Phase 2 | CFTR |