TOREMIFENE CITRATE
Toremifene citrate treats metastatic breast cancer in women who have gone through menopause. It is used for patients whose tumors are either estrogen-receptor positive or have an unknown receptor status. This medication helps manage advanced cancer by targeting the hormonal pathways that contribute to tumor progression.
How TOREMIFENE CITRATE Works
As a nonsteroidal triphenylethylene derivative, this medication works by binding to estrogen receptors and competing with natural estrogen for these sites. This action blocks the growth-stimulating effects of estrogen, which helps prevent the tumor from expanding.
Details
- Status
- Prescription
- First Approved
- 2018-12-04
- Routes
- ORAL
- Dosage Forms
- TABLET
TOREMIFENE CITRATE Approval History
What TOREMIFENE CITRATE Treats
1 indicationsTOREMIFENE CITRATE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
TOREMIFENE CITRATE Boxed Warning
QT PROLONGATION Toremifene citrate tablets have been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology ( 12.2 )]. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the ...
WARNING: QT PROLONGATION Toremifene citrate tablets have been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology ( 12.2 )]. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided [see Warnings and Precautions ( 5.1 )]. WARNING: QT PROLONGATION Toremifene citrate tablets have been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology ( 12.2 )]. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided [see Warnings and Precautions ( 5.1) ].
TOREMIFENE CITRATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TOREMIFENE CITRATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TOREMIFENE CITRATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TOREMIFENE CITRATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03238703 | 9764 NCI-2017-00724, 9764 | Ph 4 | withdrawn | Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
TOREMIFENE CITRATE FDA Label Details
Indications & Usage
TOREMIFENE CITRATE is indicated for the treatment of Breast Cancer.
WARNING: QT PROLONGATION Toremifene citrate tablets have been shown to prolong the QTc interval in a dose- and concentration-related manner [see Clinical Pharmacology ( 12.2 )]. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may resul...
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FARESTON
Full clinical data, patents, trials, and competitive landscape for toremifene citrate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.