Modality
ASO
MOA
Cl18.2
Target
JAK1
Pathway
T-cell
Epilepsy
Development Pipeline
Preclinical
~Mar 2013
→ ~Jun 2014
Phase 1
~Sep 2014
→ ~Dec 2015
Phase 2
~Mar 2016
→ ~Jun 2017
Phase 3
Sep 2017
→ Jan 2029
Phase 3Current
NCT04762270
1,975 pts·Epilepsy
2023-04→2029-01·Completed
NCT04483859
2,168 pts·Epilepsy
2018-04→TBD·Completed
NCT07271608
2,476 pts·Epilepsy
2017-09→2027-08·Terminated
6,619 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-08-031.3y awayPh3 Readout· Epilepsy
2029-01-262.8y awayPh3 Readout· Epilepsy
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
P3
Termina…
P3
Complet…
P3
Complet…
Catalysts
Ph3 Readout
2027-08-03 · 1.3y away
Epilepsy
Ph3 Readout
2029-01-26 · 2.8y away
Epilepsy
CompletedTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04762270 | Phase 3 | Epilepsy | Completed | 1975 | FEV1 |
| NCT04483859 | Phase 3 | Epilepsy | Completed | 2168 | eGFR |
| NCT07271608 | Phase 3 | Epilepsy | Terminated | 2476 | EASI-75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| GIL-8529 | Gilead Sciences | Phase 1/2 | JAK1 | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| VKT-6548 | Viking Therapeutics | Phase 2/3 | PD-L1 | |
| Tiratapinarof | Intellia | NDA/BLA | APOC3 | |
| MLY-3531 | Mineralys | NDA/BLA | JAK1 |