Modality
Small Molecule
MOA
JAK1/2i
Target
CDK2
Pathway
Hedgehog
PVBreast Ca
Development Pipeline
Preclinical
~Mar 2021
→ ~Jun 2022
Phase 1
~Sep 2022
→ ~Dec 2023
Phase 2
Mar 2024
→ Feb 2031
Phase 2Current
NCT07109052
2,960 pts·PV
2024-10→2025-02·Recruiting
NCT03439943
1,005 pts·PV
2024-03→2031-02·Recruiting
3,965 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-02-011.2y agoPh3 Readout· PV
2031-02-194.9y awayPh3 Readout· PV
Trial Timeline
Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P2/3
Recruit…
P2/3
Recruit…
Catalysts
Ph3 Readout
2025-02-01 · 1.2y ago
PV
Ph3 Readout
2031-02-19 · 4.9y away
PV
Recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07109052 | Phase 2/3 | PV | Recruiting | 2960 | eGFR |
| NCT03439943 | Phase 2/3 | PV | Recruiting | 1005 | HAM-D |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| Fixanesiran | AbbVie | Preclinical | RET | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| VRT-9481 | Vertex Pharma | Phase 1/2 | Menin |