NDAORALCAPSULEPriority Review
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
5/8 — Partial
Priority Review
AUGTYRO (repotrectinib) by Bristol Myers Squibb is proto-oncogene tyrosine-protein kinase ros1 inhibitors [moa]. First approved in 2023.
Drug data last refreshed 1h ago · AI intelligence enriched 3mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUGTYRO (repotrectinib) is an oral ROS1 tyrosine kinase inhibitor approved by the FDA in November 2023 for the treatment of ROS1-positive non-small cell lung cancer. The drug works by inhibiting the proto-oncogene tyrosine-protein kinase ROS1, blocking aberrant signaling in cancer cells. It represents a targeted therapy approach for a specific genomic subset of lung cancer patients.
Growth9.8 years to LOE
Early-stage commercial product with significant growth potential as market awareness and patient identification accelerates in the ROS1-positive NSCLC space.
Mechanism of Action
Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion
Started May 2026
10 enrolled
Non-Small Cell Lung Cancer
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
Repotrectinib Post-Marketing Surveillance in Pediatric Patients With NTRK Fusion-Positive Tumors in Japan
Started Nov 2025
20 enrolled
NTRK Fusion-positive Solid Tumors
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
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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.