Modality
mRNA
MOA
GLP-1/GIP
Target
IL-23
Pathway
Lipid Met
SMADLBCLGastric Ca
Development Pipeline
Preclinical
~Oct 2011
→ ~Jan 2013
Phase 1
~Apr 2013
→ ~Jul 2014
Phase 2
~Oct 2014
→ ~Jan 2016
Phase 3
~Apr 2016
→ ~Jul 2017
NDA/BLA
Oct 2017
→ May 2030
NDA/BLACurrent
NCT05162677
1,983 pts·SMA
2017-10→2027-12·Terminated
NCT04483233
1,091 pts·Gastric Ca
2023-01→2030-05·Recruiting
3,074 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-12-101.7y awayPh3 Readout· SMA
2030-05-134.1y awayPh3 Readout· Gastric Ca
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
NDA/BLA
Termina…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2027-12-10 · 1.7y away
SMA
Ph3 Readout
2030-05-13 · 4.1y away
Gastric Ca
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05162677 | NDA/BLA | SMA | Terminated | 1983 | ACR20 |
| NCT04483233 | NDA/BLA | Gastric Ca | Recruiting | 1091 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zanuderotide | Johnson & Johnson | Phase 2/3 | TIGIT | |
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| AZN-5171 | AstraZeneca | Approved | GLP-1R | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| DSN-6862 | Daiichi Sankyo | Preclinical | IL-23 | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| Pemiinavolisib | Sarepta | NDA/BLA | CD47 | |
| Fixalucimab | Innovent Bio | Phase 1/2 | IL-23 | |
| Gelisertib | Samsung Biologics | Approved | IL-23 |