Drug · Small Molecule

Osimertinib

CI-DRUG-00000423Explore in graph →NCIt C116377 CHEMBL3353410 CIViC Approved

Regulatory

Approvals (16)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as TAGRISSO (DIN 02456214) under ATC L01EB04 OSIMERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 19, 2016	health-canada-dpd
CA Health Canada	—	Marketed in Canada as TAGRISSO (DIN 02456222) under ATC L01EB04 OSIMERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 19, 2016	health-canada-dpd

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 hours 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 4	119	49	36	206	16	CA, EU, US	Nov 13, 2015	Mar 4, 2013
Malignant Lung Neoplasm	Approved	Phase 4	95	41	26	165	6	EU, US	Nov 13, 2015	Mar 4, 2013
Malignant Breast Neoplasm	Phase2	Phase 2	2	1	0	3	0	—	—	Aug 17, 2015
Malignant Esophageal Neoplasm	Phase2	Phase 2	2	0	0	2

Curated evidence

Clinical evidence (62)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 51–62 of 62 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
EGFR T790M3
Osimertinib + Rociletinib

Clinical trials

Trials with this intervention (223)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 201–223 of 223 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04816838	A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Neoadjuvant Osimertinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harbouring EGFR Mutations	unknown	N/A	25	Yonsei UniversityOTHER	1	Aug 25, 2021	clinicaltrials
NCT03257124	Study of AZD9291 in NSCLC Patients Harboring T790M Mutation Who Failed EGFR TKI and With Brain and/or LMS	unknown

Molecule

Record

Kind: Small Molecule
Mechanism: Epidermal growth factor receptor erbB1 inhibitor
Targets: 1 gene
UNII: 3C06JJ0Z2O
Aliases: 2-Propenamide, N-(2-((2-(dimethylamino)ethyl)methylamino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)-2-pyrimidinyl)amino)phenyl)-, AZD 9291, AZD-9291, AZD9291, AZD-9291 FREE BASE, Mereletinib, Osimertinib, Osimertinib Mesylate, Tagrisso, TAGRISSO

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (7)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EB04	OSIMERTINIB
ATC (WHO)	L01XE	Other antineoplastic agents; Protein kinase inhibitors
DIN (Health Canada)