Drug

Osimertinib

Established medicine

ClassEpidermal growth factor receptor erbB1 inhibitorResearchActive indication expansion

Also known as Tagrisso, Mereletinib, Osimertinibum.

RxNorm1721560 ChEMBLCHEMBL3353410 ATCL01EB04UNII3C06JJ0Z2O

Research papers

116

Active clinical trials

Epidermal growth factor receptor

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1/2 Study of Osimertinib in Combination With Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

Clinical trial2026-10-31Primary completion · ClinicalTrials.gov

A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Clinical trial2026-10-31Primary completion · ClinicalTrials.gov

Osimertinib-Savolitinib Boosts Survival in MET+ NSCLC

Industry2026-10-29Medscape Medical News

Phase II Trial of the Addition of Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma

Clinical trial2026-10-28Results expected Q1 2027 · ClinicalTrials.gov

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)

Clinical trial2026-10-23Results expected Q2 2028 · ClinicalTrials.gov

Indication expansion: OSIMERTINIB (NDA208065)

Regulatory2026-09-14FDA

Label change: OSIMERTINIB (NDA208065)

Regulatory2026-09-14FDA

Indication expansion: OSIMERTINIB (NDA208065)

Regulatory2024-09-25FDA

Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC.

Research2024-06-26The New England journal of medicine

Label change: OSIMERTINIB (NDA208065)

Regulatory2024-04-29FDA

Current treatment strategies for EGFR-mutated non-small cell lung cancer: from first line to beyond osimertinib resistance.

Research2023-06-01Japanese journal of clinical oncology

Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial.

Research2023-01-31Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Osimertinib

Aliases & brands

TagrissoMereletinibOsimertinibum

RxNorm CUI

1721560

ChEMBL ID

CHEMBL3353410

ATC codes

L01EB04

UNII

3C06JJ0Z2O

Primary mechanism

Epidermal growth factor receptor erbB1 inhibitor

Regulatory jurisdictions

fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Epidermal growth factor receptor

EGFR · P00533

INHIBITOREpidermal growth factor receptor erbB1 inhibitor

Regulatory timeline

25 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2015-11-13

Latest approval

2026-09-14

Authorities

FDA

Total events

fdaU.S. Food and Drug Administration· 25 events

2026-09-14Label change

Label change: OSIMERTINIB (NDA208065)

Evidence ↗

2026-09-14Indication expansion

Indication expansion: OSIMERTINIB (NDA208065)

Evidence ↗

2024-09-25Indication expansion

Indication expansion: OSIMERTINIB (NDA208065)

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

183 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

183

registered trials across all phases

LATEST COMPLETION 2026

116

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 183

Early Phase 12Phase 134Phase 1 / 223Phase 286Phase 2 / 35Phase 326Phase 43Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

AFAMOSI: Prospective, Randomized, Multicenter Phase IV Study to Evaluate the Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients with EGFRmutated/T790M Mutation Negative Non-squamous NSCLC in the First-line Setting

Active, not recruitingPH IVMichael Hoppn=342026

Efficacy Study of Osimertinib in Treatment-naïve Patients With EGFR Mutant NSCLC According to TP53 Mutational Status.

Unknown statusPH IVFondazione Policlinico Universitario Agostino Gemelli IRCCSn=1222025

A Prospective, Multicenter, Phase-IV Clinical Trial to Assess Safety of Osimertinib in Indian Adult Patients With Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-positive Non-small Cell Lung Cancer (NSCLC).

CompletedPH IVAstraZenecan=602020

A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

RecruitingPH II/IIIAbbVien=8542036

Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

RecruitingPH IIINRG Oncologyn=4742036

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)

CompletedPH IIEMD Serono Research & Development Institute, Inc.n=1402026

The Efficacy and Safety of Osimertinib Plus Carboplatin and Pemetrexed Versus Osimertinib Monotherapy in Metastatic EGFRm NSCLC Patients With EGFRm Persistence in ctDNA at 3 Weeks After 1L Osimertinib: A Multicenter, Randomized Controlled Study

CompletedPH IIBeijing Cancer Prevention & Treatment Societyn=802026

An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

CompletedPH I/IIIncyte Corporationn=592025

Phase 1 Study of Combination Dacomitinib and Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers

CompletedPH IMemorial Sloan Kettering Cancer Centern=222025

A Phase I/Ib Study of Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer

CompletedPH ICollin Blakelyn=232025

A Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Patients With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Patients With Metastatic Colorectal Cancer

CompletedPH IGenentech, Inc.n=102025

Research activity

11 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

2015–2024

Most influential

Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer.

The New England journal of medicine · 2018 · 4,173 cites

Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.

The New England journal of medicine · 2017 · 2,677 cites

Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC.

The New England journal of medicine · 2020 · 2,267 cites

AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer.

The New England journal of medicine · 2015 · 1,655 cites

Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer.

The New England journal of medicine · 2020 · 1,373 cites

Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 308 cites

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Carcinoma, Non-Small-Cell Lung9 Lung Neoplasms9 Neoplasm Recurrence, Local2

Related drugs

6 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Erlotinib Hydrochloride

Acts on the same molecular target as Osimertinib, with 2 overlapping disease areas.

Shared target2 shared diseases2 shared papers

Gefitinib

Acts on the same molecular target as Osimertinib, with 2 overlapping disease areas.

Shared target2 shared diseases2 shared papers

Amivantamab

Acts on the same molecular target as Osimertinib, with 2 overlapping disease areas.

Shared target2 shared diseases1 shared paper

Lazertinib

Acts on the same molecular target as Osimertinib, with 2 overlapping disease areas.

Shared target2 shared diseases1 shared paper

Platinum

Studied across 3 of the same disease areas as Osimertinib in the shared literature.

3 shared diseases1 shared paper

Pemetrexed

Studied across 2 of the same disease areas as Osimertinib in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.