Data updated: May 26, 2026
AROMASIN (exemestane)
Aromatase Inhibitors
Trial Activity: Stable 36 active trials
Oncology
Approved 1999-10-21
Aromasin treats postmenopausal women with estrogen-receptor positive early breast cancer who have already completed two to three years of tamoxifen therapy. It is used to help patients finish a total five-year course of hormonal therapy after switching from their initial treatment. This medication also helps patients with advanced breast cancer when the disease has progressed following tamoxifen use.
How AROMASIN Works
This medication works by irreversibly inactivating aromatase, the enzyme responsible for converting androgens into estrogen in postmenopausal women. By acting as a "suicide inhibitor," it binds to the enzyme's active site and significantly lowers the amount of circulating estrogen available to fuel cancer cell growth.
Development Insights
Novartis Pharmaceuticals conducting 12 trials (10%)
138 indications explored (Broad Platform)
→ breast cancer (44 trials)
→ breast neoplasms (15 trials)
→ metastatic breast cancer (12 trials)
3
Indications
--
Phase 3 Trials
26
Years on Market
Details
- Status
- Prescription
- First Approved
- 1999-10-21
- Routes
- ORAL
- Dosage Forms
- TABLET
AROMASIN Approval History
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 1999 to 2024 · 2 indication expansions
Jul 2014 SUPPL
Mfg
Apr 2001 SUPPL
Mfg
What AROMASIN Treats
1 indicationsAROMASIN is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
Source: FDA Label
AROMASIN Competitive Set
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Indication competitors
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What's emerging in AROMASIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AROMASIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AROMASIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
119 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06169124 | NCI-2023-06524 NCI-2023-06524, NRG-GY033 | Ph 2 | active not recruiting | Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors |
| NCT07391774 | NCI-2026-00634 NCI-2026-00634, EA1242 | Ph 3 | not yet recruiting | 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 |
| NCT06979596 | 5684-015 2024-519563-18-00, U1111-1315-5430 | Ph 2 | recruiting | A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) |
| NCT06075953 | RECAST-DCIS | Ph 2 | recruiting | DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment |
| NCT05827081 Adjuvant WIDER | CLEE011O12001 2022-503001-38-00 | Ph 3 | recruiting | Phase IIIb Study of Ribociclib + ET in Early Breast Cancer |
| NCT06671912 LoTam | A012301 NCI-2024-06672 | Ph 3 | suspended | Testing Low Dose Tamoxifen for Invasive Breast Cancer, the (LoTam) Trial |
| NCT05774951 CAMBRIA-1 | D8531C00002 2022-501024-20-00 | Ph 3 | recruiting | A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy |
| NCT07062965 | C4551002 2025-520566-22-00 | Ph 3 | recruiting | A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. |
| NCT03179904 results posted | MC1633 W81XWH-16-1-0269, W81XWH-16-1-0268 | Ph 2 | active not recruiting | TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer |
| NCT01272037 results posted | NCI-2011-02623 NCI-2011-02623, S12-03603 | Ph 3 | active not recruiting | Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer |
| NCT02115282 results posted | NCI-2014-00746 NCI-2014-00746, ECOG-E2112 | Ph 3 | active not recruiting | Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic |
| NCT05306340 | ML43171 2022-000199-20, 2023-506821-12-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) |
| NCT07174336 | 27726 J6M-MC-JSGD, 2025-522791-92-00 | Ph 3 | recruiting | A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) |
| NCT06630325 results posted | STUDY00026643 NCI-2024-07664, STUDY00026643 | Ph 2 | terminated | A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer |
| NCT06428396 | 6482-029 MK-6482-029, LITESPARK-029 | Ph 2 | recruiting | Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) |
| NCT06492616 ELEGANT | STML-ELA-0422 2024-515445-42-00 | Ph 3 | recruiting | A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence |
| NCT05768139 PIKALO-1 | 27691 2023-504807-94-00, 2023-000442-41 | Ph 1, Ph 2 | recruiting | First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors |
| NCT06179303 | RG1122019 NCI-2022-06409, FHIRB0020029 | Ph 2 | recruiting | Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer |
| NCT01553903 OXYTAM | 11 SEIN 09 | Ph 4 | completed | Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not |
| NCT06380751 EvoPAR-BR01 | D9722C00001 | Ph 3 | recruiting | Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer |
| NCT05467891 RaPhLRR | HCRN BRE20-468 | Ph 2 | recruiting | Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer |
| NCT05514054 EMBER-4 | 18459 J2J-MC-JZLH, 2022-501007-28 | Ph 3 | active not recruiting | A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer |
| NCT07499999 BabyTEARS | 25-550 | Ph 2 | not yet recruiting | Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer |
| NCT05573126 | EP0062-101 | Ph 1, Ph 2 | recruiting | Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer |
| NCT00893061 MNEMOSYNE | MNEMOSYNE-0712 2008-003620-32 | Ph 3 | completed | Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer |
| NCT06016738 OPERA-01 | OP-1250-301 OPERA-01 | Ph 3 | recruiting | OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer |
| NCT04572295 | E7090-J081-102 | Ph 1 | active not recruiting | A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer |
| NCT04059484 AMEERA-3 results posted | ACT16105 U1111-1217-2774, 2018-004593-98 | Ph 2 | terminated | Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer |
| NCT06105632 | C4391022 2023-506487-13-00 | Ph 2 | active not recruiting | A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment |
| NCT02947685 PATINA results posted | AFT-38 | Ph 3 | active not recruiting | Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer |
| NCT01674140 e3 results posted | S1207 S1207, U10CA032102 | Ph 3 | active not recruiting | S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer |
| NCT02057133 | 15252 I3Y-MC-JPBH | Ph 1 | active not recruiting | A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread |
| NCT06001762 | 23-355 | Ph 2 | active not recruiting | TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer |
| NCT03280563 MORPHEUS HR+BC results posted | CO39611 2017-000335-14 | Ph 1, Ph 2 | completed | A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer |
| NCT02007512 results posted | MDV3100-12 2013-002717-35, C3431008 | Ph 2 | completed | Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer |
| NCT03300557 results posted | NCI-2017-01782 NCI-2017-01782, UW17010 | Ph 2 | completed | Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer |
| NCT04300790 METALLICA | MEDOPP240 2019-003970-26 | Ph 2 | completed | Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients |
| NCT02476786 | 201611010 | Ph 2 | recruiting | Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score |
| NCT02123823 results posted | 1280.4 2013-001110-15 | Ph 1 | completed | BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer |
| NCT04975308 EMBER-3 results posted | 18175 J2J-OX-JZLC, 2021-000079-35 | Ph 3 | active not recruiting | A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer |
| NCT05952557 CAMBRIA-2 | D8535C00001 2023-504031-41-00 | Ph 3 | recruiting | An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) |
| NCT03554044 | 17753 NCI-2018-00652 | Ph 1 | completed | T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer |
| NCT06957379 | HB1901-005 | Ph 2 | active not recruiting | Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy |
| NCT03219476 results posted | PRO30178 | Ph 2 | completed | Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer |
| NCT06223698 SWE-Switch | 280050 | Ph 3 | not yet recruiting | Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer |
| NCT03659136 results posted | 1280-0022 2017-003131-11 | Ph 2 | completed | The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread |
| NCT03691493 ASPIRE results posted | IRB00105944 NCI-2018-02000, Winship4472-18 | Ph 2 | completed | Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis |
| NCT01870505 results posted | 13-027 | Ph 1 | completed | BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer |
| NCT04985266 TRAK-ER | CCR5316 | Ph 2 | recruiting | A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer |
| NCT02028507 PEARL results posted | GEICAM/2013-02 2013-003170-27 | Ph 3 | completed | Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors |
Showing 50 of 119 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AROMASIN FDA Label Details
Indications & Usage
FDA Label (PDF)AROMASIN is indicated for the treatment of Breast Cancer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment