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Drug

Exemestane

In clinical development
ClassCytochrome P450 19A1 inhibitorEmerging researchLate-stage developmentSteady momentum

Also known as Aromasin, Exemestano, 6-methyleneandrosta-1,4-diene-3,17-dione, Exemestanum.

RxNorm258494ChEMBLCHEMBL1200374ATCL02BG06UNIINY22HMQ4BX
4
Research papers
43
Active clinical trials
Aromatase
Primary target
Latest activity
beta

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

A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Clinical trial2026-07-30Results expected Q2 2029 · ClinicalTrials.gov

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)

Clinical trial2026-07-10Results expected Q2 2027 · ClinicalTrials.gov

A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment for High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS≤25 (RxFINE-Low)

Clinical trial2026-07-10Results expected Q3 2029 · ClinicalTrials.gov

A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

Clinical trial2026-07-08Results expected Q3 2029 · ClinicalTrials.gov

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Clinical trial2026-07-08Results expected Q3 2029 · ClinicalTrials.gov

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Clinical trial2026-07-07Results expected Q3 2030 · ClinicalTrials.gov

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

A randomized phase II trial of ridaforolimus, dalotuzumab, and exemestane compared with ridaforolimus and exemestane in patients with advanced breast cancer.

Research2017-07-05Breast cancer research and treatment

Exemestane for breast-cancer prevention in postmenopausal women.

Research2011-06-04The New England journal of medicine

National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: evaluation of exemestane to prevent breast cancer in postmenopausal women.

Research2007-12-01Clinical breast cancer

A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer.

Research2004-03-01The New England journal of medicine

Profile

Identifiers & mechanism

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

Canonical name
Exemestane
Aliases & brands
AromasinExemestano6-methyleneandrosta-1,4-diene-3,17-dioneExemestanum
RxNorm CUI
258494
ChEMBL ID
CHEMBL1200374
ATC codes
L02BG06
UNII
NY22HMQ4BX
Primary mechanism
Cytochrome P450 19A1 inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Aromatase
CYP19A1 · P11511
INHIBITORCytochrome P450 19A1 inhibitor

Clinical trials

194 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
194
registered trials across all phases
LATEST COMPLETION 2026
43
Active studies
26
Recruiting
80
Late-stage (III+)
106
Completed
45
Discontinued
PHASE DISTRIBUTIONn = 194
Phase 118Phase 1 / 28Phase 288Phase 2 / 31Phase 363Phase 48Phase N / A8

Late-stage studies

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

An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)

WithdrawnPH IVFred Hutchinson Cancer Center2025

PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant

TerminatedPH IVPalleos Healthcare GmbHn=5322021

A PROSPECTIVE PRAGMATIC CLINICAL TRIAL OF CHINA EARLY INVASIVE BREAST CANCER PATIENTS RECEIVING ADJUVANT THERAPY WITH AROMASIN

CompletedPH IVPfizern=5642018

Effects of Cimicifuga Racemosa L. Nutt Sexuality of Women With Breast Cancer Using Tamoxifen or Aromatase Inhibitor

Unknown statusPH IVIrmandade da Santa Casa de Misericordia de Sao Paulon=602017

An Open Label, randomIzed Controlled Prospective Multicenter Two Arm Phase IV Trial to Determine Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab for Advanced (Inoperable or Metastatic) HER2-negative Hormone Receptor Positive Breast Cancer

CompletedPH IViOMEDICO AGn=852017

Recent completions

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

MC1633 Phase II Trial to Evaluate the Efficacy of the FASN Inhibitor, TVB-2640, in Combination With Trastuzumab Plus Paclitaxel or Endocrine Therapy in Patients With HER2+ Metastatic Breast Cancer Resistant to Trastuzumab-Based Therapy

CompletedPH IIMayo Clinicn=172026

Pilot Study of Daily Exemestane in Women With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer

CompletedPH IINational Cancer Institute (NCI)n=402025

Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance

CompletedPH IIMedical College of Wisconsinn=372025

Study to Evaluate the Effect of Metformin in the Prevention of Hyperglycemia in HR[+]/HER2[-] PIK3CA-mutation Advanced Breast Cancer Patients Treated With Alpelisib Plus Endocrine Therapy. Study Metallica

CompletedPH IIMedSIRn=692025

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer

CompletedPH IIIKey trialETOP IBCSG Partners Foundationn=3,0662024

A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer

CompletedPH IIIKey trialETOP IBCSG Partners Foundationn=2,6722024

Research activity

4 papers

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

Publications over time
20042017
Major research themes3
Aromatase Inhibitors1Postmenopause1Research Design1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
  • Breast cancer research and treatment1
  • Clinical breast cancer1
Leading researchers
  • Goss PE2
  • Ingle JN2
  • Maunsell E2
  • Richardson H2
  • Sarto GE2
  • Afonso N1
  • Alés-Martinez JE1
  • Alés-Martínez JE1
Leading institutions
free-text, unnormalised
  • Baylor Sammons Cancer Center1
  • Centre Léon Bérard1
  • Diller Family Comprehensive Cancer Center1
  • Harvard Medical School1
  • Imperial College and Charing Cross Hospital1
  • Institut de Cancérologie de l'Ouest1

Related drugs

1 matches

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

Tamoxifen

Studied across 2 of the same disease areas as Exemestane 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