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Fareston

(toremifene)

ApprovedSmall molecule

Kyowa Kirin Co., Ltd.

Toremifene is used to treat breast cancer in postmenopausal women. It works by blocking estrogen in the body, which helps slow or stop the growth of estrogen-dependent breast cancer cells.[2] Fareston is currently approved and in use across 5 indications[4].[1]

Fareston is one of 68 small molecule programs targeting Bone Fracture. It is currently in Approved.

5

Indications

23

Total Trials

1

Active Trials

67

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Bone FractureApproved

MastodyniaApproved

Desmoid-Type FibromatosisApproved

Prostate Intraepithelial NeoplasiaApproved

Breast CancerCompleted

Bone FractureApproved

Approved

MastodyniaApproved

Approved

Desmoid-Type FibromatosisApproved

Approved

Prostate Intraepithelial NeoplasiaApproved

Approved

Breast CancerApproved

Completed

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Fareston

Kyowa Kirin Co., Ltd.

Adenocard

Blenoxane

Bristol-Myers Squibb

Lexiscan

Voltaren

Zolymbus

MS Contin

HHikma Pharmaceuticals LLC

Duragesic-100

MS Contin

HHikma Pharmaceuticals LLC

Spravato

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2031

Phase 3Recruiting

Breast Cancer

NCT05891093

Clinical

Trials by Indication[1]

Breast Cancer12 trials

Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer

Terminated·IIntarcia Therapeutics·Phase 3·NCT00010322

Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

Terminated·IIntarcia Therapeutics·Phase 3·NCT00267553·200 enrolled

Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02344940·104 enrolled

Show 9 more trials

Hormone Therapy and Chemotherapy in Treating Perimenopausal or Postmenopausal Women With Node-Positive Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00002529·452 enrolled

The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Terminated·IIntarcia Therapeutics·Phase 3·NCT00097344·842 enrolled

Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer

Unknown status·CChinese Anti-Cancer Association·Phase 3·NCT03351062·844 enrolled

Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Function Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World Study

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University··NCT05801705·700 enrolled

Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

Unknown status·NN.N. Petrov National Medical Research Center of Oncology·Phase 2·NCT02506790·96 enrolled

Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Completed·IIntarcia Therapeutics·Phase 3·NCT00044291·865 enrolled

Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

Unknown status·PPeking Union Medical College Hospital·Phase 3·NCT02097459·600 enrolled

Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

Recruiting·FFudan University·Phase 3·NCT05891093·766 enrolled

Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea

Unknown status·PPeking Union Medical College Hospital·Phase 3·NCT02132390·300 enrolled

Prostate Cancer2 trials

Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer

Completed·JJoel Nelson, MD·Phase 2·NCT00020735·45 enrolled

Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer

Withdrawn·GGTx·Phase 3·NCT01214291

Ovarian Cancer1 trial

Toremifene in Treating Patients With Ovarian Cancer

Withdrawn·GGeorge Washington University·Phase 2·NCT00003865

Ultrasound1 trial

Changes in Breast 3D Ultrasound Measurements Using Toremifene

Completed·—·Phase 3·NCT01417754·20 enrolled

Clinical Trial1 trial

Toremifene in Desmoid Tumor: Prospective Clinical Trial and Identification of Potential Molecular Targets

Unknown status·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 2·NCT02353429·25 enrolled

6 more indications

COVID-191 trial

Selective Estrogen Modulation and Melatonin in Early COVID-19

Withdrawn·—·Phase 2·NCT04531748

Endocrine Therapy1 trial

Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast

Unknown status·FFirst Hospital of China Medical University··NCT04666805·1,354 enrolled

Desmoid Tumor1 trial

Toremifene in Treating Patients With Desmoid Tumors

Completed·—·Phase 2·NCT00002595·72 enrolled

Magnetic Resonance Imaging (MRI)1 trial

The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia

Completed·—·Phase 3·NCT00534846·10 enrolled

Intraepithelial Neoplasia1 trial

Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)

Completed·GGTx·Phase 3·NCT00106691·1,589 enrolled

Women1 trial

Estradiol-Receptor Blockade in Older Men and Women

Completed·MMayo Clinic·Phase 1·NCT02271282·40 enrolled

Regulatory

FDA Approval Timeline[5]

May 29, 1997

FARESTON

NDA NDA020497

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for toremifene. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Fareston drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — toremifene compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for toremifene. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020497). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Kyowa Kirin Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Estrogen Receptor Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Kyowa Kirin Co., Ltd.

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