NDAORALCAPSULEPriority Review
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
6/8 — Strong
Priority Review
AUGTYRO (repotrectinib) by Bristol Myers Squibb is proto-oncogene tyrosine-protein kinase ros1 inhibitors [moa]. Approved for non-small cell lung cancer. First approved in 2023.
Drug data last refreshed 20h ago
Mechanism of Action
Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications (1)
Clinical Trials (6)
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
30 enrolled
Healthy Volunteers
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
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
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
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.