AUGTYRO

GrowthSM

repotrectinib

NDAORALCAPSULEPriority Review
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
6

Mechanism of Action

Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors

Pharmacologic Class:

Kinase Inhibitor

Clinical Trials (5)

NCT07223671Phase 1Recruiting

Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants

Started Dec 2025
32 enrolled
Healthy Volunteers
NCT06493409Phase 1Completed

A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants

Started Aug 2024
32 enrolled
Healthy Volunteers
NCT06352528Phase 1Completed

A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

Started Apr 2024
18 enrolled
Hepatic ImpairmentHealthy Volunteers
NCT06140836Phase 3Active Not Recruiting

A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

Started Dec 2023
190 enrolled
Carcinoma, Non-Small-Cell Lung
NCT03093116Phase 1/2Recruiting

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Started Mar 2017
500 enrolled
Locally Advanced Solid TumorsMetastatic Solid Tumors

Loss of Exclusivity

LOE Date
Jul 24, 2036
126 months away
Patent Expiry
Jul 24, 2036
Exclusivity Expiry
Jun 13, 2031

Patent Records (5)

Patent #ExpiryTypeUse Code
RE50634
Jan 23, 2035
SubstanceProduct
10294242
Jul 5, 2036
Substance
12187739
Jul 5, 2036
Product
12310968
Jul 20, 2036
U-3755
11452725
Jul 24, 2036
U-3755