Modality
siRNA
MOA
IL-17i
Target
Aβ
Pathway
DDR
CSU
Development Pipeline
Preclinical
~Feb 2014
→ ~May 2015
Phase 1
~Aug 2015
→ ~Nov 2016
Phase 2
~Feb 2017
→ ~May 2018
Phase 3
~Aug 2018
→ ~Nov 2019
NDA/BLA
~Feb 2020
→ ~May 2021
Approved
Aug 2021
→ Aug 2031
ApprovedCurrent
NCT08825350
677 pts·CSU
2021-08→2028-09·Terminated
NCT04880321
1,805 pts·CSU
2025-06→2031-08·Not yet recruiting
2,482 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2028-09-172.5y awayPh3 Readout· CSU
2031-08-165.4y awayPh3 Readout· CSU
Trial Timeline
Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Termina…
Approved
Not yet…
Catalysts
Ph3 Readout
2028-09-17 · 2.5y away
CSU
Ph3 Readout
2031-08-16 · 5.4y away
CSU
TerminatedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08825350 | Approved | CSU | Terminated | 677 | DAS28 |
| NCT04880321 | Approved | CSU | Not yet recr... | 1805 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| Bemalucimab | Bristol-Myers Squibb | Phase 1/2 | Aβ | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| VRT-5853 | Vertex Pharma | Phase 3 | Aβ | |
| Elrarapivir | Vertex Pharma | NDA/BLA | PRMT5 | |
| Rimaglumide | Biogen | Phase 1/2 | BCL-2 |