Modality
Gene Therapy
MOA
FGFRi
Target
JAK1
Pathway
Apoptosis
NBCSUMCL
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
→ ~Jan 2019
Approved
Apr 2019
→ Mar 2027
ApprovedCurrent
NCT04207559
2,034 pts·CSU
2019-04→2027-03·Completed
NCT05900343
548 pts·CSU
2025-03→2025-12·Recruiting
2,582 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2025-12-074mo agoPh3 Readout· CSU
2027-03-2512mo awayPh3 Readout· CSU
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
Approved
Complet…
Approved
Recruit…
Catalysts
Ph3 Readout
2025-12-07 · 4mo ago
CSU
Ph3 Readout
2027-03-25 · 12mo away
CSU
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04207559 | Approved | CSU | Completed | 2034 | SRI-4 |
| NCT05900343 | Approved | CSU | Recruiting | 548 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-9749 | Eli Lilly | Phase 3 | C5 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| LLY-1956 | Eli Lilly | Phase 1/2 | BCMA | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| GIL-8529 | Gilead Sciences | Phase 1/2 | JAK1 | |
| SRP-9822 | Sarepta | Phase 3 | SOS1 | |
| Rimainavolisib | Illumina | Phase 2 | PD-1 | |
| Elrainavolisib | Roivant Sciences | Preclinical | Nectin-4 | |
| MLY-3531 | Mineralys | NDA/BLA | JAK1 |