Data updated: Jul 17, 2026
LAROTRECTINIB · ALEMBIC PHARMACEUTICALS LIMITED
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- N/A
- Dosage Forms
- CAPSULE
LAROTRECTINIB Approval History
No approval records found
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT06390852 | NCI-2024-01138 NCI-2024-01138, EAY131-Z1E | Ph 2 | active not recruiting | Testing LOXO-101 as Potentially Targeted Treatment in Cancers With NTRK Genetic Changes (MATCH - Subprotocol Z1E) |
| NCT06563999 NUMER | GASTO-10117 | Ph 2 | recruiting | Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. |
| NCT07010393 | Real-Neo | Ph 4 | not yet recruiting | Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study |
| NCT06482086 | 202314711 | Ph 2 | recruiting | Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer |
| NCT05725200 EVIDENT | EVIDENT | Ph 2 | recruiting | Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
LAROTRECTINIB FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.