Modality
mRNA
MOA
FcRni
Target
SOS1
Pathway
Sphingolipid
CSUMM
Development Pipeline
Preclinical
~Feb 2015
→ ~May 2016
Phase 1
~Aug 2016
→ ~Nov 2017
Phase 2
Feb 2018
→ Dec 2030
Phase 2Current
NCT07490000
2,162 pts·CSU
2019-01→2028-06·Completed
NCT07491805
226 pts·CSU
2018-02→2030-12·Completed
2,388 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-06-042.2y awayPh3 Readout· CSU
2030-12-274.7y awayPh3 Readout· CSU
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P2/3
Complet…
P2/3
Complet…
Catalysts
Ph3 Readout
2028-06-04 · 2.2y away
CSU
Ph3 Readout
2030-12-27 · 4.7y away
CSU
Completed|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07490000 | Phase 2/3 | CSU | Completed | 2162 | SRI-4 |
| NCT07491805 | Phase 2/3 | CSU | Completed | 226 | CfB |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| Terarelsin | AbbVie | Preclinical | SOS1 | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| Voxacagene | Gilead Sciences | Phase 2/3 | SOS1 | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| SRP-9822 | Sarepta | Phase 3 | SOS1 | |
| Zanufutibatinib | Intra-Cellular | NDA/BLA | CD38 | |
| Fixaosocimab | TG Therapeutics | Phase 2/3 | SOS1 | |
| Zanurapivir | Immunocore | Phase 1 | SOS1 |