OSIMERTINIB MESYLATE · ZYDUS PHARMS USA
OSIMERTINIB MESYLATE is FDA-approved to treat 5 conditions (same as TAGRISSO).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-11-13
- Routes
- ORAL
- Dosage Forms
- TABLET
OSIMERTINIB MESYLATE Approval History
What OSIMERTINIB MESYLATE Treats
5 indicationsOSIMERTINIB MESYLATE is approved for 5 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adjuvant therapy after tumor resection in adult patients with EGFR exon 19 deletions or exon 21 L858R mutation-positive non-small cell lung cancer (NSCLC)
- Locally advanced, unresectable (stage III) EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC that has not progressed during or following platinum-based chemoradiation therapy
- First-line treatment of adult patients with metastatic EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC
- First-line treatment of adult patients with locally advanced or metastatic EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC, in combination with pemetrexed and platinum-based chemotherapy
- Metastatic EGFR T790M mutation-positive NSCLC in patients whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy
Same approved indications as TAGRISSO (same active ingredient).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06525246 | ONO-7475-03 jRCT2051210045 | Ph 1 | completed | Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer |
| NCT07229729 | SHR-A2102-212 | Ph 2 | recruiting | A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer |
| NCT06829459 | SYH2065-002 | Ph 3 | recruiting | A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs |
| NCT06530719 | IRB-2024-701 | Ph 2 | not yet recruiting | A Study to Evaluate the Efficacy of Osimertinib in Patients With EGFR-sensitive Mutated Non-small Cell Lung Cancer Progression After Receiving Adjuvant Targeted Therapy Following Radical Surgery |
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.
OSIMERTINIB MESYLATE FDA Label Details
Indications & Usage
OSIMERTINIB MESYLATE is FDA-approved to treat 5 conditions — same approved indications as TAGRISSO.
Looking for the branded version?
TAGRISSO
Full clinical data, patents, trials, and competitive landscape for osimertinib mesylate.
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