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Label indication THYROGEN ® is a thyroid stimulating hormone indicated for: Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. FDA label
Also known as Thyrogen (thyrotropin alfa for injection), Thyrogen
Thyrogen+ Radioiodine · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Thyrogen (thyrotropin alfa for injection) | DRUG | No reference therapy was given. All patients in this follow-up study received Thyrogen. Thyrogen 0.9 mg was administered intramuscularly (IM) in the buttock on 2 consecutive days. For WBS and static neck imaging, each patient received 4 mCi (148 MBq) ± 0.4 mCi 131I PO. |
| Thyrogen + Radioiodine (131I) | DRUG | - |
Inclusion Criteria: * Committed to follow the protocol requirements, as evidenced by providing written informed consent before any study-related procedures are performed and within 28 days prior to Day 1; * Completed the THYR-008-00 study; * A negative serum pregnancy test within 8 days prior to th...
Thyrogen+ Radioiodine is used in patients with differentiated thyroid cancer and thyroid neoplasms. It combines Thyrogen (thyrotropin alfa for injection) with radioactive iodine (131I) to destroy remaining thyroid tissue after thyroidectomy, a process called thyroid remnant ablation. It is studied in adults 18 years and older.
Thyrogen is developed and manufactured by Sanofi, which trades under the ticker SNY. The combined Thyrogen plus radioiodine regimen uses Sanofi's thyrotropin alfa for injection alongside radioactive iodine 131I.
Thyrogen+ Radioiodine has been studied in Phase 3 clinical development. The trials in this program are listed as completed, and the drug is not described as approved for this use. It remains an investigational regimen in clinical research.
Two Phase 3 trials have evaluated Thyrogen with radioiodine. NCT00196729 compared safety and successful thyroid remnant ablation in Thyrogen-treated euthyroid patients versus hypothyroid patients after 131I administration. NCT00295763 was a follow-up study of thyroid cancer patients from the earlier comparison. Both trials are completed.
The Thyrogen plus radioiodine clinical program enrolled 63 patients in NCT00196729 and 61 patients in the NCT00295763 follow-up study. Participants were adults, with NCT00196729 enrolling patients 20 years and older and NCT00295763 enrolling patients 18 years and older, across the United States, Canada, France, Germany, and Italy.