AUGTYRO (repotrectinib) · Bristol-Myers Squibb
Augtyro (repotrectinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). It is also indicated for adult and pediatric patients 12 years of age and older with solid tumors that harbor an NTRK gene fusion, are locally advanced or metastatic (or where surgical resection would cause severe morbidity), and have progressed following previous treatment or have no satisfactory alternative therapy. The NTRK indication is approved under accelerated approval based on response rate and duration of response.
How AUGTYRO Works
Repotrectinib is an inhibitor of the proto-oncogene tyrosine-protein kinase ROS1 and the tropomyosin receptor tyrosine kinases TRKA, TRKB, and TRKC. Fusion proteins involving ROS1 or TRK domains lead to hyperactivation of downstream signaling pathways, driving unconstrained cell proliferation and tumorigenesis. Repotrectinib inhibits these pathways and demonstrates activity against specific ROS1 and NTRK resistance
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-11-15
- Patent Cliff
- 2036
- Revenue
- $15M (Q4-2024)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
AUGTYRO Approval History
What AUGTYRO Treats
2 indicationsAUGTYRO is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
- Solid Tumors
AUGTYRO 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.
AUGTYRO 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 AUGTYRO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AUGTYRO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AUGTYRO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Bristol-Myers Squibb's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06552234 REPOROS | REPOROS GFPC 04-2023 2023-509073-23-00 | Ph 2 | recruiting | Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC |
| NCT07223671 | CA127-1088 | Ph 1 | completed | Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants |
| NCT05004116 | 21-156 | Ph 1, Ph 2 | recruiting | A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer |
| NCT06315010 REPOSE | MedOPP662 2023-508112-35-00, CA127-1061 | Ph 2 | recruiting | REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis |
| NCT06408168 | 2024-0099 NCI-2024-03805 | Ph 2 | terminated | Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial) |
| NCT06140836 | CA127-1030 U1111-1292-0487 | Ph 3 | active not recruiting | 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) |
| NCT06352528 | CA127-1070 | Ph 1 | completed | A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment |
| NCT06493409 | CA127-1072 | Ph 1 | completed | A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants |
| NCT04772235 TOTEM | IOR-TPT-IST-002 2020-005151-20 | Ph 1 | recruiting | Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients |
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.
AUGTYRO FDA Label Details
Indications & Usage
FDA Label (PDF)AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and dur...
AUGTYRO Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for AUGTYRO
Revenue Insights
- • Q4-2024: $15M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 24 active patents
Trial Analysis
- • 9 total trials
- • Stage: Growth
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment