Modality
ERT
MOA
STINGag
Target
CD3
Pathway
Proteasome
Endometrial CaCSUIPF
Development Pipeline
Preclinical
~Jan 2015
→ ~Apr 2016
Phase 1
~Jul 2016
→ ~Oct 2017
Phase 2
Jan 2018
→ May 2027
Phase 2Current
NCT05015801
374 pts·CSU
2018-01→2027-05·Completed
374 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-05-031.1y awayPh3 Readout· CSU
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3
P2/3
Complet…
Catalysts
Ph3 Readout
2027-05-03 · 1.1y away
CSU
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05015801 | Phase 2/3 | CSU | Completed | 374 | CfB |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-5389 | Roche | Preclinical | RET | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| SNY-5783 | Sanofi | Phase 1/2 | MET | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| DSN-1421 | Daiichi Sankyo | Phase 3 | Nectin-4 | |
| GIL-4361 | Gilead Sciences | Preclinical | PCSK9 | |
| Miriglumide | Alnylam | Phase 3 | CD3 | |
| INC-5849 | Incyte | Phase 2 | PCSK9 | |
| Miritinib | Neurocrine | Phase 3 | TIGIT | |
| Talatuximab | Samsung Biologics | Preclinical | CD3 |