THYROGEN (thyrotropin alfa)
Thyrogen is used for patients with well-differentiated thyroid cancer who have previously undergone surgery to remove their thyroid gland. It helps healthcare providers monitor for cancer recurrence by assisting with blood tests for thyroglobulin and radioiodine imaging scans. This medication is also used to help destroy remaining thyroid tissue remnants through radioiodine ablation in patients who do not have evidence of cancer that has spread to distant parts of the body.
How THYROGEN Works
This drug works by binding to TSH receptors on both normal thyroid cells and well-differentiated thyroid cancer tissue. This activation stimulates the cells to take up iodine and release thyroglobulin, a protein that acts as a tumor marker in the blood. By increasing iodine uptake, the medication allows for better detection of cancer during scans or helps radioiodine effectively destroy remaining thyroid cells.
Details
- Status
- Prescription
- First Approved
- 1998-11-30
- Patent Cliff
- 2014
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
THYROGEN Approval History
What THYROGEN Treats
1 indicationsTHYROGEN is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thyroid Cancer
THYROGEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03841617 | 190050 19-DK-0050 | Ph 2 | recruiting | The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer |
Active Pipeline
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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.
THYROGEN FDA Label Details
Indications & Usage
FDA Label (PDF)THYROGEN is indicated for the treatment of Thyroid Cancer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.