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Thyrogen + Radioiodine (131I)
Thyrogen + Radioiodine (131I) is a Recombinant hormone + radiopharmaceutical combination Small molecule drug developed by Genzyme, a Sanofi Company. It is currently in Phase 3 development for Thyroid cancer (differentiated thyroid cancer with radioiodine-avid metastases), Thyroid remnant ablation in thyroid cancer patients.
Thyrogen (recombinant human TSH) stimulates thyroid tissue to take up radioiodine (131I), enabling targeted destruction of thyroid cancer cells and metastases.
Thyrogen (recombinant human TSH) stimulates thyroid tissue to take up radioiodine (131I), enabling targeted destruction of thyroid cancer cells and metastases. Used for Thyroid cancer (differentiated thyroid cancer with radioiodine-avid metastases), Thyroid remnant ablation in thyroid cancer patients.
At a glance
| Generic name | Thyrogen + Radioiodine (131I) |
|---|---|
| Sponsor | Genzyme, a Sanofi Company |
| Drug class | Recombinant hormone + radiopharmaceutical combination |
| Target | TSH receptor (TSHR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Thyrogen is a recombinant form of thyroid-stimulating hormone (TSH) that binds to TSH receptors on thyroid follicular cells, stimulating them to produce thyroglobulin and increase iodine uptake. When combined with radioactive iodine-131, this enhanced uptake allows the radioactive isotope to concentrate in thyroid tissue and metastases, delivering targeted radiation to destroy thyroid cancer cells while minimizing systemic exposure.
Approved indications
- Thyroid cancer (differentiated thyroid cancer with radioiodine-avid metastases)
- Thyroid remnant ablation in thyroid cancer patients
Common side effects
- Hypothyroidism
- Headache
- Nausea
- Fatigue
- Radiation-related effects (salivary gland dysfunction, bone marrow suppression)
Key clinical trials
- RAI Plus Immunotherapy for Recurrent/Metastatic Thyroid Cancers (EARLY_PHASE1)
- Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study (EARLY_PHASE1)
- Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment (NA)
- Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal (PHASE3)
- The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer. (PHASE2)
- Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer (PHASE3)
- Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients? (PHASE3)
- Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131 (PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Thyrogen + Radioiodine (131I) CI brief — competitive landscape report
- Thyrogen + Radioiodine (131I) updates RSS · CI watch RSS
- Genzyme, a Sanofi Company portfolio CI
Frequently asked questions about Thyrogen + Radioiodine (131I)
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Related
- Drug class: All Recombinant hormone + radiopharmaceutical combination drugs
- Target: All drugs targeting TSH receptor (TSHR)
- Manufacturer: Genzyme, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Thyroid cancer (differentiated thyroid cancer with radioiodine-avid metastases)
- Indication: Drugs for Thyroid remnant ablation in thyroid cancer patients
- Compare: Thyrogen + Radioiodine (131I) vs similar drugs
- Pricing: Thyrogen + Radioiodine (131I) cost, discount & access