NDAORALCAPSULEPriority Review
Approved
Nov 2023
Lifecycle
Peak
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 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUGTYRO (repotrectinib) is an oral ROS1 inhibitor—a small-molecule kinase inhibitor designed to block proto-oncogene tyrosine-protein kinase ROS1 signaling. It treats ROS1-positive cancers by inhibiting the driver mutation responsible for uncontrolled cell growth. The drug represents a targeted precision oncology approach for patients whose tumors harbor activating ROS1 fusions.
Growth9.7 years to LOE
Early-stage growth product with 9.8 years of patent protection; commercial infrastructure building phase likely presents expansion opportunities for experienced oncology teams.
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 Oct 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.