IBTROZI

LaunchSM

taletrectinib

NDAORALCAPSULEPriority Review
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
0/100

Mechanism of Action

ROS1, including ROS1 resistance mutations. Taletrectinib also showed inhibitory effects on tropomyosin receptor kinases (TRKs) TRKA, TRKB, and TRKC. Fusion proteins that include ROS1 domains can drive tumorigenic potential through hyperactivation of downstream signaling pathways leading to…

Indications (3)

Administration ()]metastatic ROS1 -positive non-small cell lung cancer (NSCLC)lung cancer

Loss of Exclusivity

LOE Date
Jun 3, 2033
88 months away
Patent Expiry
Jun 3, 2033
Exclusivity Expiry
Jun 11, 2030

Patent Records (2)

Patent #ExpiryTypeUse Code
9187489
Jun 3, 2033
SubstanceProduct
U-4207
9751887
Jun 3, 2033
SubstanceProduct
U-4207
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers