IBTROZI (taletrectinib adipate)
Ibtrozi treats adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive for the ROS1 biomarker. This medication helps patients whose cancer has spread within the chest or to distant parts of the body. It is used to target specific genetic fusions and mutations that drive tumor growth in this specific type of lung cancer.
How IBTROZI Works
This medication works by inhibiting the ROS1 tyrosine kinase, including specific resistance mutations, as well as TRK proteins. By blocking these signaling pathways, the drug prevents the hyperactivation that leads to uncontrolled cell proliferation and tumor growth. It has shown the ability to inhibit cancer cells in both body tissues and the brain.
Details
- Status
- Prescription
- First Approved
- 2025-06-11
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- CAPSULE
IBTROZI Approval History
What IBTROZI Treats
1 indicationsIBTROZI is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
IBTROZI Target & Pathway
ProTarget
A receptor tyrosine kinase similar to ALK. ROS1 gene fusions occur in 1-2% of lung cancers and drive tumor growth. Drugs targeting ROS1 block this oncogenic signaling, leading to tumor shrinkage in ROS1-positive cancers.
IBTROZI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in IBTROZI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IBTROZI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to IBTROZI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IBTROZI FDA Label Details
Indications & Usage
FDA Label (PDF)IBTROZI is indicated for the treatment of Non-Small Cell Lung Cancer.
IBTROZI Patents & Exclusivity
Exclusivity
Pro Intelligence Preview
Deep insights for IBTROZI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.