Modality
Small Molecule
MOA
PCSK9i
Target
CD19
Pathway
Lipid Met
GISTMCC
Development Pipeline
Preclinical
~Apr 2015
→ ~Jul 2016
Phase 1
~Oct 2016
→ ~Jan 2018
Phase 2
Apr 2018
→ Sep 2029
Phase 2Current
NCT04226228
2,583 pts·MCC
2018-04→2026-04·Terminated
NCT06754103
478 pts·MCC
2020-05→2029-09·Completed
3,061 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-04-233w awayPh3 Readout· MCC
2029-09-023.4y awayPh3 Readout· MCC
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P2/3
Termina…
P2/3
Complet…
Catalysts
Ph3 Readout
2026-04-23 · 3w away
MCC
Ph3 Readout
2029-09-02 · 3.4y away
MCC
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04226228 | Phase 2/3 | MCC | Terminated | 2583 | FEV1 |
| NCT06754103 | Phase 2/3 | MCC | Completed | 478 | HAM-D |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-8662 | Pfizer | NDA/BLA | CD19 | |
| NVS-6974 | Novartis | Preclinical | CD19 | |
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| INC-1261 | Incyte | Phase 1/2 | PRMT5 | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα |