ROZLYTREK

LOE Approaching

entrectinib

NDAORALPELLETSPriority Review
Approved
Oct 2023
Lifecycle
LOE Approaching
Competitive Pressure
35/100
Clinical Trials
13

Mechanism of Action

(TRK) TRKA, TRKB, and TRKC (encoded by the neurotrophic tyrosine receptor kinase [ NTRK ] genes NTRK1, NTRK2, and NTRK3 , respectively), proto-oncogene tyrosine-protein kinase ROS1 (ROS1), and anaplastic lymphoma kinase (ALK) with IC 50 values of 0.1 to 2 nM. Entrectinib also inhibits JAK2 and TNK2…

Clinical Trials (5)

NCT06528691Phase 2Recruiting

Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors

Started Mar 2026
52 enrolled
High Grade GliomaCNS Tumor
NCT05770544Phase 2/3Recruiting

DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.

Started Nov 2025
30 enrolled
Haematological MalignancyMalignancyMalignant Neoplasm+8 more
NCT05396859Phase 1Active Not Recruiting

Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia

Started Oct 2022
13 enrolled
Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia
NCT04603807Phase 3Active Not Recruiting

A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases

Started Sep 2021
220 enrolled
Carcinoma, Non-Small-Cell Lung
NCT04589832Phase 1/2Terminated

Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma

Started Jan 2021
6 enrolled
Uveal Melanoma

Loss of Exclusivity

LOE Date
Oct 20, 2026
7 months away
Exclusivity Expiry
Oct 20, 2030