Modality
siRNA
MOA
PLK4i
Target
CD38
Pathway
Neuroinflam
CFCSUFSGS
Development Pipeline
Preclinical
~Apr 2016
→ ~Jul 2017
Phase 1
~Oct 2017
→ ~Jan 2019
Phase 2
Apr 2019
→ Jun 2028
Phase 2Current
NCT07437639
1,253 pts·CSU
2019-04→TBD·Completed
NCT06764667
23 pts·CSU
2021-07→2028-06·Not yet recruiting
1,276 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-06-102.2y awayPh3 Readout· CSU
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
P2/3
Complet…
P2/3
Not yet…
Catalysts
Ph3 Readout
2028-06-10 · 2.2y away
CSU
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07437639 | Phase 2/3 | CSU | Completed | 1253 | EFS |
| NCT06764667 | Phase 2/3 | CSU | Not yet recr... | 23 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| Ivosotorasib | Vertex Pharma | Preclinical | CD38 | |
| Zenotapinarof | Vertex Pharma | Preclinical | CD38 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| Motazanubrutinib | Biogen | Preclinical | CD38 |