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 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 1–50 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
NCT06075953	DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment	recruiting	Phase 2	400	QuantumLeap Healthcare CollaborativeOTHER	1	Sep 28, 2026	clinicaltrials
NCT07391774	Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

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 22 minutes 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)