Modality
mRNA
MOA
BCL-2i
Target
IL-17A
Pathway
Sphingolipid
CMLPsA
Development Pipeline
Preclinical
~Nov 2018
→ ~Feb 2020
Phase 1
~May 2020
→ ~Aug 2021
Phase 2
~Nov 2021
→ ~Feb 2023
Phase 3
~May 2023
→ ~Aug 2024
NDA/BLA
Nov 2024
→ Aug 2031
NDA/BLACurrent
NCT07346189
2,703 pts·CML
2025-04→2029-07·Terminated
NCT03703862
1,339 pts·PsA
2024-11→2031-08·Not yet recruiting
4,042 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-07-023.3y awayPh3 Readout· CML
2031-08-225.4y awayPh3 Readout· PsA
Trial Timeline
Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2029-07-02 · 3.3y away
CML
Ph3 Readout
2031-08-22 · 5.4y away
PsA
TerminatedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07346189 | NDA/BLA | CML | Terminated | 2703 | Biomarker |
| NCT03703862 | NDA/BLA | PsA | Not yet recr... | 1339 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| GIL-9779 | Gilead Sciences | Phase 1 | IL-17A | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 | |
| NBI-408 | Neurocrine | Phase 2/3 | KRASG12D | |
| HAL-996 | Halozyme | Phase 1/2 | BCL-2 | |
| RVM-7089 | Revolution Medicines | Phase 3 | IL-17A |