Modality
Small Molecule
MOA
PCSK9i
Target
HER2
Pathway
Autophagy
ALL
Development Pipeline
Preclinical
~May 2022
→ ~Aug 2023
Phase 1
Nov 2023
→ May 2025
Phase 1Current
NCT05946323
298 pts·ALL
2023-11→2025-05·Active
298 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-05-0711mo agoPh2 Data· ALL
2026-10-247mo awayBTD· ALL
Trial Timeline
2024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
P1/2
Active
Catalysts
Ph2 Data
2025-05-07 · 11mo ago
ALL
BTD
2026-10-24 · 7mo away
ALL
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05946323 | Phase 1/2 | ALL | Active | 298 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| INC-1261 | Incyte | Phase 1/2 | PRMT5 | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| ROI-9675 | Roivant Sciences | NDA/BLA | HER2 |