Modality
ADC
MOA
CAR-T CD19
Target
PI3Kα
Pathway
Cell Cycle
WMLGSPNH
Development Pipeline
Preclinical
~Nov 2017
→ ~Feb 2019
Phase 1
May 2019
→ Dec 2031
Phase 1Current
NCT03865749
2,099 pts·WM
2021-05→2025-03·Recruiting
NCT07879972
2,900 pts·LGS
2019-05→2031-12·Terminated
4,999 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-03-091.1y agoInterim· WM
2031-12-095.7y awayInterim· LGS
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P1
Termina…
P1
Recruit…
Catalysts
Interim
2025-03-09 · 1.1y ago
WM
Interim
2031-12-09 · 5.7y away
LGS
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03865749 | Phase 1 | WM | Recruiting | 2099 | Safety |
| NCT07879972 | Phase 1 | LGS | Terminated | 2900 | FEV1 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Datoglumide | AbbVie | Approved | CFTR | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| Talasotorasib | Exelixis | Preclinical | APOC3 | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα |