Drug · Small Molecule

Exemestane

CI-DRUG-00000228Explore in graph →NCIt C1097 CHEMBL1200374 CIViC Approved

Regulatory

Approvals (11)

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-dpdRegulatory11 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as APO-EXEMESTANE (DIN 02419726) under ATC L02BG06 EXEMESTANE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Aug 4, 2017	May 1, 2014	health-canada-dpd
CA Health Canada	—	Marketed in Canada as MED-EXEMESTANE (DIN 02407841) under ATC L02BG06 EXEMESTANE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 2, 2013	health-canada-dpd
CA Health Canada	—	Marketed in Canada as TEVA-EXEMESTANE (DIN 02408473) under ATC L02BG06 EXEMESTANE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Market

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 2 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 4	42	21	64	199	11	CA, US	Oct 21, 1999	1996-05
Malignant Breast Neoplasm	Approved	Phase 4	26	14	48	127	2	US	Oct 21, 1999	1996-05
Malignant Ovarian Neoplasm	Phase3	Phase 3	0	0	1	3	0	—	—	2003-01
Malignant Cervical Neoplasm	Phase2	Phase 2	0	0	0	1	0

Curated evidence

Clinical evidence (4)

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

civicCuratedShowing 1–4 of 4 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
ESR2 underexpression beta-11
Exemestane + Tamoxifen

Clinical trials

Trials with this intervention (212)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 212 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
NCT02007512	Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer	completed	Phase 2	247	PfizerINDUSTRY	7	Sep 2, 2025	clinicaltrials
NCT03300557	Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer	completed

Molecule

Record

Kind: Small Molecule
Mechanism: Cytochrome P450 19A1 inhibitor
Targets: 1 gene
UNII: NY22HMQ4BX
Aliases: 6-Methyleneandrosta-1,4-diene-3,17-dione, ACT EXEMESTANE, APO-EXEMESTANE, Aromasin, AROMASIN, Exemestane, Exemestano, FCE-24304, FCE24304, GD-EXEMESTANE, MED-EXEMESTANE, MYLAN-EXEMESTANE, NSC-758907, PNU-155971, TEVA-EXEMESTANE

Data updated 11 hours agoSource updated unknown

Identifiers

Codes (15)

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

System	Code	Label
ATC (WHO)	L02BG06	EXEMESTANE
DIN (Health Canada)	02242705	AROMASIN
DIN (Health Canada)