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.

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2016-07-25 (see label)	approved	Jul 25, 2016	openfda
US FDA	—	Efficacy supplement 2005-10-05 (see label)	approved	Oct 5, 2005	openfda
US FDA	Malignant Breast Neoplasm	adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ).	approved	Oct 21, 1999	openfda
US FDA	Malignant Breast Neoplasm	treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ).

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 3 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 101–150 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
NCT02820961	Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer	completed	Phase 1	61	Syndax PharmaceuticalsINDUSTRY	1	Dec 15, 2021	clinicaltrials
NCT01594398	Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer(ENCORE110)

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 15 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)