Modality
ADC
MOA
PLK4i
Target
PI3Kα
Pathway
PI3K/AKT
BCCCFPompe
Development Pipeline
Preclinical
~Jun 2018
→ ~Sep 2019
Phase 1
Dec 2019
→ Sep 2030
Phase 1Current
NCT06846171
1,901 pts·Pompe
2020-02→2025-07·Completed
NCT05124177
1,346 pts·BCC
2019-12→2030-09·Terminated
3,247 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-07-159mo agoInterim· Pompe
2026-03-064w agoAdCom· Pompe
2030-09-134.5y awayInterim· BCC
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P1
Termina…
P1
Complet…
Catalysts
Interim
2025-07-15 · 9mo ago
Pompe
AdCom
2026-03-06 · 4w ago
Pompe
Interim
2030-09-13 · 4.5y away
BCC
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06846171 | Phase 1 | Pompe | Completed | 1901 | DOR |
| NCT05124177 | Phase 1 | BCC | Terminated | 1346 | DAS28 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα | |
| ROI-1081 | Roivant Sciences | Phase 1/2 | PI3Kα |