IBTROZI
LaunchSMtaletrectinib
NDAORALCAPSULEPriority Review
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
5/8 — Partial
Priority Review
IBTROZI (taletrectinib) is ros1, including ros1 resistance mutations. First approved in 2025.
Drug data last refreshed 4h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IBTROZI (taletrectinib) is an oral small-molecule ROS1 tyrosine kinase inhibitor approved for ROS1-positive non-small-cell lung cancer, including tumors with ROS1 resistance mutations. The drug also inhibits tropomyosin receptor kinases (TRK A/B/C) and demonstrated tumor growth inhibition in both subcutaneous and intracranial xenograft models.
Launch6.9 years to LOE
Early-stage launch product with 7 years of patent exclusivity; commercial infrastructure building and field force expansion expected.
Mechanism of Action
ROS1, including ROS1 resistance mutations. Taletrectinib also showed inhibitory effects on tropomyosin receptor kinases (TRKs) TRKA, TRKB, and TRKC. Fusion proteins that include ROS1 domains can drive tumorigenic potential through hyperactivation of downstream signaling pathways leading to…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression
Started Oct 2025
50 enrolled
Non-small Lung Cancer
Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)
Started Aug 2025
180 enrolled
Non-small Cell Lung Cancer (NSCLC)
Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
Started Jun 2025
100 enrolled
Non-Small Cell Lung Cancer
A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients
Started Nov 2024
194 enrolled
Non Small Cell Lung Cancer
Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC
Started Sep 2021
217 enrolled
Non Small Cell Lung Cancer
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.