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Thyrogen
Thyrogen is a recombinant human thyrotropin that stimulates thyroid cells to produce and release thyroid hormones, aiding in the diagnosis and treatment of thyroid cancer.
Thyrogen, developed by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is a recombinant human thyrotropin used primarily in the management of thyroid cancer. It is designed to stimulate thyroid cells to produce and release thyroid hormones, which can help in the detection and treatment of residual or recurrent thyroid cancer. Despite its potential benefits, Thyrogen does not have an FDA-approved label, indicating that it may be used under specific investigational protocols or off-label. The drug has a favorable safety profile but includes some common side effects such as headache, nausea, and fatigue. Its use is generally well-tolerated, but patients should be monitored for any adverse reactions.
At a glance
| Generic name | Thyrogen |
|---|---|
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Drug class | Recombinant human thyrotropin |
| Target | Thyrotropin receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Thyrogen mimics the action of endogenous thyroid-stimulating hormone (TSH) by binding to TSH receptors on thyroid cells, leading to increased production and secretion of thyroid hormones.
Approved indications
- Serum thyroglobulin level
Pipeline indications
Common side effects
- Headache
- Nausea
- Fatigue
- Myalgia
- Arthralgia
Key clinical trials
- Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer (PHASE2)
- The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer (PHASE2)
- Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation (PHASE2)
- CASE 1320: RAI Uptake and Serum Prolactin in Thyroid Cancer
- Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE) (PHASE2)
- Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis (PHASE2)
- Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids (PHASE2)
- Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |