Modality
ASO
MOA
Cl18.2
Target
CDK4/6
Pathway
PI3K/AKT
RBAMLBreast Ca
Development Pipeline
Preclinical
May 2025
→ Sep 2031
PreclinicalCurrent
NCT07622695
52 pts·Breast Ca
2025-10→2031-09·Completed
NCT05547109
1,396 pts·Breast Ca
2025-05→2030-08·Active
1,448 total pts1 indication
Phase 1
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2030-08-044.3y awayInterim· Breast Ca
2031-09-075.4y awayInterim· Breast Ca
Trial Timeline
Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Preclinical
Active
Preclinical
Complet…
Catalysts
Interim
2030-08-04 · 4.3y away
Breast Ca
Interim
2031-09-07 · 5.4y away
Breast Ca
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07622695 | Preclinical | Breast Ca | Completed | 52 | ACR20 |
| NCT05547109 | Preclinical | Breast Ca | Active | 1396 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| VKT-6548 | Viking Therapeutics | Phase 2/3 | PD-L1 | |
| Tiratapinarof | Intellia | NDA/BLA | APOC3 | |
| Elralucimab | Axsome | Phase 2 | CDK4/6 | |
| ELV-1411 | Enliven | NDA/BLA | HER2 |