NDAORALTABLETPriority Review
Approved
Mar 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Mechanism of Action
PI3K-delta by blocking the active binding site of PI3K-delta. In cell-free isolated enzyme assays, leniolisib was selective for PI3K-delta over PI3K-alpha (28-fold), PI3K-beta (43-fold), and PI3K-gamma (257-fold), as well as the broader kinome. In cell-based assays, leniolisib reduced pAkt pathway…
Clinical Trials (1)
Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation
Started Apr 2025
Loss of Exclusivity
LOE Date
Feb 19, 2032
72 months away
Patent Expiry
Feb 19, 2032
Exclusivity Expiry
Mar 24, 2030
Patent Records (1)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 8653092 | Feb 19, 2032 | SubstanceProduct | — |