Drug · Small Molecule
Osimertinib Mesylate
CI-DRUG-00000424Explore in graph →NCIt C170266 CHEMBL3545063 CIViC Approved
Regulatory
Approvals (13)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
openfdaProvenance
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2024-09-25 (see label) | approved | Sep 25, 2024 | openfda |
| US FDA | — | Efficacy supplement 2024-02-16 (see label) | approved | Feb 16, 2024 | openfda |
| US FDA | — | Efficacy supplement 2024-01-31 (see label) | approved | Jan 31, 2024 | openfda |
| US FDA | — | Efficacy supplement 2020-12-18 (see label) | approved | Dec 18, 2020 | openfda |
| US |
Data updated 20 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 3 | 2 | 1 | 5 | 13 | US | Nov 13, 2015 | Aug 6, 2021 |
| Malignant Lung Neoplasm | Approved | Phase 3 | 3 | 2 | 1 | 5 | 5 | US | Nov 13, 2015 | Aug 6, 2021 |
ComputedclinicaltrialsProvenance
- Source
- clinicaltrials
- Layer
- derived (computed by CancerIndex)
Curated evidence
Clinical evidence (1)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 41590375
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| EGFR E701fs + EGFR L702fs1 | ||||||||
| Osimertinib Mesylate | ||||||||
Clinical trials
Trials with this intervention (5)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06525246 | Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer | completed | Phase 1 | 78 | Ono Pharmaceutical Co., Ltd.INDUSTRY | 1 | Mar 13, 2026 | clinicaltrials |
| NCT07229729 | A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer | recruiting |