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Exemestane

Generic Name
Exemestane
Brand Names
Aromasin
Drug Type
Small Molecule
Chemical Formula
C20H24O2
CAS Number
107868-30-4
Unique Ingredient Identifier
NY22HMQ4BX

Overview

Exemestane is an oral steroidal aromatase inhibitor used in the adjuvant treatment of hormonally-responsive (also called hormone-receptor-positive, estrogen-responsive) breast cancer in postmenopausal women. It irreversibly binds to the active site of the enzyme resulting in permanent inhibition.

Indication

For the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

Associated Conditions

  • Stage I Breast Cancer
  • Refractory, advanced Breast cancer

Research Report

Published: Jun 19, 2025

An Analytical Report on Two Paradigms in Oncologic Therapy: The Established Aromatase Inhibitor Exemestane and the Investigational Treg Modulator GIM-531

Part I: Exemestane (Aromasin®) - A Comprehensive Clinical and Pharmacological Profile

This section provides a definitive review of Exemestane, leveraging its extensive history of clinical use and regulatory documentation to build a complete profile of a mature, yet still critical, oncologic agent.

1.1. Molecular Identity and Physicochemical Properties

Exemestane is a cornerstone therapeutic agent in the management of hormone receptor-positive breast cancer. Its efficacy is intrinsically linked to its unique chemical structure and physical properties, which dictate its biological activity and clinical application.

Chemical Structure and Classification

Exemestane is an oral steroidal aromatase inhibitor.[1] Its chemical designation is 6-methylenandrosta-1,4-diene-3,17-dione.[1] As a steroidal compound, it is structurally analogous to the natural substrate of the aromatase enzyme, androstenedione.[2] This structural mimicry is not a coincidence but rather the fundamental basis of its mechanism of action, allowing it to be recognized and processed by the target enzyme, which ultimately leads to the enzyme's inactivation. It is classified as a 17-oxo steroid and a 3-oxo-Delta(1),Delta(4)-steroid, deriving from a hydride of an androstane.[1]

Molecular Formula and Weight

The molecular formula of exemestane is C20​H24​O2​, corresponding to a molecular weight of 296.41 g/mol [3] and an average weight of 296.4034 g/mol.[2] Its monoisotopic mass is 296.177630004 Da.[1]

Physical Characteristics

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/14
Not Applicable
Not yet recruiting
2025/06/17
Phase 3
Not yet recruiting
Shandong Suncadia Medicine Co., Ltd.
2025/05/20
Phase 2
Not yet recruiting
2025/05/04
Phase 2
Active, not recruiting
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2024/11/08
Phase 3
Recruiting
2024/11/04
Phase 3
Recruiting
2024/10/08
Phase 2
Recruiting
2024/07/09
Phase 3
Recruiting
2024/05/24
Phase 2
Recruiting
2024/04/24
Phase 3
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Physicians Total Care, Inc.
54868-5261
ORAL
25 mg in 1 1
1/4/2010
Bryant Ranch Prepack
63629-2056
ORAL
25 mg in 1 1
12/30/2021
Amneal Pharmaceuticals LLC
65162-240
ORAL
25 mg in 1 1
11/19/2022
Florida Pharmaceutical Products, LLC
71921-190
ORAL
25 mg in 1 1
6/19/2023
Breckenridge Pharmaceutical, Inc.
51991-005
ORAL
25 mg in 1 1
1/25/2024
A-S Medication Solutions
50090-5193
ORAL
25 mg in 1 1
5/1/2018
Upsher-Smith Laboratories, Inc.
0832-0595
ORAL
25 mg in 1 1
1/31/2022
Pharmacia & Upjohn Company LLC
0009-7663
ORAL
25 mg in 1 1
11/1/2021
Eirgen Pharma Ltd
44278-025
ORAL
25 mg in 1 1
2/9/2021
Greenstone LLC
59762-2858
ORAL
25 mg in 1 1
11/1/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
EXEMESTANE ALVOGEN FILM-COATED TABLETS 25MG
N/A
N/A
N/A
8/7/2012

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
TEVA-EXEMESTANE
teva canada limited
02408473
Tablet - Oral
25 MG
10/1/2013
MED-EXEMESTANE
generic medical partners inc
02407841
Tablet - Oral
25 MG
12/2/2013
AROMASIN
02242705
Tablet - Oral
25 MG
8/17/2000
ACT EXEMESTANE
teva canada limited
02390183
Tablet - Oral
25 MG
7/26/2012
MYLAN-EXEMESTANE
Mylan Pharmaceuticals ULC
02405075
Tablet - Oral
25 MG
N/A
GD-EXEMESTANE
genmed a division of pfizer canada ulc
02359693
Tablet - Oral
25 MG
N/A
APO-EXEMESTANE
02419726
Tablet - Oral
25 MG
5/1/2014

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
EXEMESTANO CINFA 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Laboratorios Cinfa S.A.
76699
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
EXEMESTANO DESGEN 25 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG
Laboratorio Generfarma S.L.
74921
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
EXEMESTANO FARMALIDER 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Farmalider S.A.
77007
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
EXEMESTANO WINADOL 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Farmalider S.A.
77006
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
EXEMESTANO RATIOPHARM 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Teva Pharma S.L.U.
75999
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
EXEMESTANO TECNIGEN 25 mg COMPRIMIDOS RECUBIERTOS EFG
Tecnimede España Industria Farmaceutica S.A.
74309
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
AROMASIL 25 mg COMPRIMIDOS RECUBIERTOS
Pfizer S.L.
63029
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica
Commercialized
EXEMESTANO STADA 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Laboratorio Stada S.L.
73240
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
AROMASIL 25 MG COMPRIMIDOS RECUBIERTOS
LT-1-2000-1224-001
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica
Commercialized
EXEMESTANO VIR 25 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG
Industria Quimica Y Farmaceutica Vir S.A.
75283
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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