Modality
Small Molecule
MOA
RAS(ON)i
Target
FLT3
Pathway
Cell Cycle
GACSU
Development Pipeline
Preclinical
~May 2018
→ ~Aug 2019
Phase 1
~Nov 2019
→ ~Feb 2021
Phase 2
May 2021
→ Jun 2027
Phase 2Current
NCT05629370
976 pts·GA
2023-01→2027-06·Not yet recruiting
NCT06530675
647 pts·GA
2021-05→TBD·Not yet recruiting
1,623 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-06-011.2y awayPh3 Readout· GA
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3
P2/3
Not yet…
P2/3
Not yet…
Catalysts
Ph3 Readout
2027-06-01 · 1.2y away
GA
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05629370 | Phase 2/3 | GA | Not yet recr... | 976 | FEV1 |
| NCT06530675 | Phase 2/3 | GA | Not yet recr... | 647 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| MRK-6781 | Merck & Co | Approved | TIGIT | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| Tixarelsin | Vertex Pharma | Phase 1 | ALK | |
| Sotorapivir | Moderna | Approved | FLT3 | |
| Fixatuximab | Legend Biotech | Preclinical | CFTR | |
| ION-1378 | Ionis | NDA/BLA | TROP-2 | |
| Nidaratamab | Exelixis | Phase 3 | FLT3 | |
| 180-3597 | Innovent Bio | Preclinical | SHP2 | |
| Zanumavacamten | Iovance | Phase 2 | FLT3 |