Modality
Cell Therapy
MOA
JAK1i
Target
TIM-3
Pathway
Angiogenesis
CF
Development Pipeline
Preclinical
~Jun 2015
→ ~Sep 2016
Phase 1
~Dec 2016
→ ~Mar 2018
Phase 2
~Jun 2018
→ ~Sep 2019
Phase 3
~Dec 2019
→ ~Mar 2021
NDA/BLA
Jun 2021
→ Aug 2031
NDA/BLACurrent
NCT08399070
401 pts·CF
2021-06→2031-08·Active
401 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-08-185.4y awayPh3 Readout· CF
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Active
Catalysts
Ph3 Readout
2031-08-18 · 5.4y away
CF
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08399070 | NDA/BLA | CF | Active | 401 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-7458 | Johnson & Johnson | Phase 1/2 | PD-1 | |
| Geliderotide | Sanofi | Phase 1/2 | PRMT5 | |
| Pexaosocimab | Daiichi Sankyo | Phase 2 | PD-1 | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Adagratapinarof | Vertex Pharma | Preclinical | BCMA | |
| ARG-1924 | Argenx | Preclinical | DLL3 | |
| Nidasacituzumab | United Therapeutics | Phase 1/2 | TIM-3 | |
| ROI-1081 | Roivant Sciences | Phase 1/2 | PI3Kα | |
| Liratinib | Krystal Biotech | NDA/BLA | TIM-3 | |
| Doxazasiran | Axsome | Phase 1 | TIM-3 |