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Last Updated: June 20, 2025

CLINICAL TRIALS PROFILE FOR THYROGEN


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All Clinical Trials for Thyrogen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001730 ↗ Study of Radioiodine (131-I) Uptake Following Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal. Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 4 1997-12-01 Thyroid cancer is typically treated with surgery, radiation or a combination of both. Following surgical removal of thyroid tissue patients receive thyroid hormone replacement medication. In addition patients undergo tests to determine the status of the disease. One of the tests conducted is a whole body scan using radioactive iodine to detect and locate any remaining cancerous thyroid tissue. Thyroid tissue uses iodine to make thyroid hormones (T3 and T4). In order for a radioiodine scan to work, cancerous thyroid tissue must be "hungry" for iodine. Thyroid stimulating hormone (TSH) produced in the pituitary gland is responsible for making thyroid tissue "hungry" for iodine. Once thyroid tissue absorbs the radioactive iodine it will be clearly visible on the scan and can be located for removal. However, thyroid hormone replacement medication tends to lower the activity of the pituitary gland and the amount of naturally produced TSH. So it is necessary to stop thyroid hormone replacement to increase TSH. A problem arises when there is a lack of thyroid hormone replacement causing patients to experience hypothyroidism. This condition is associated with unpleasant physical and emotional symptoms. TSH has been created in a laboratory and called Thyrogen. It is basically the same as the TSH produced in the human pituitary gland. However, Thyrogen increases the level of TSH in the body without having to stop thyroid replacement medication. Therefore patients will not experience hypothyroidism while preparing for a radioactive iodine scan. The objective of this study is to compare the activity of radioiodine (131I) in patients taking Thyrogen with normal thyroid activity versus patients with hypothyroid activity after thyroid replacement medication is withdrawn. In addition the study will provide information on how radioactive iodine is eliminated from the body. The study will help researchers understand how to give Thyrogen and radioiodine for purposes of scanning and therapeutic ablation (the destruction of function) of cancerous thyroid tissue. The study will accept patients with non-medullary thyroid cancer who are preparing for ablation therapy. The patients will be placed in one of two groups. Group one will receive Thyrogen in 2 doses 24 hours apart. Group two will receive Thyrogen in 3 doses 72 hours apart. The patients will undergo two 131I whole body scans: one after Thyrogen while taking thyroid hormone suppressive and the second after withdrawal from thyroid hormone. 131I ablative therapy will be given under hypothyroid conditions at the completion of the study.
NCT00085293 ↗ Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131 Completed National Cancer Institute (NCI) Phase 2 2004-05-01 This phase II trial is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells. Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine. Decitabine may help thyroid cancer cells regain the ability to respond to treatment with radioactive iodine.
NCT00137891 ↗ Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone Completed Genzyme, a Sanofi Company Phase 1 2005-06-01 Forty-six (46) eligible, healthy subjects who provide written informed consent will be enrolled to participate in a 2 arm parallel group study to assess and compare the pharmacokinetics and safety profile of Thyrogen dosed at 0.1 mg versus a modified release formulation of recombinant human thyroid stimulating hormone (rhTSH) dosed at 0.1 mg. Ten (10) of these subjects will have the thyroid uptake of radioiodine (123I) measured at baseline and following their single dose of study medication. All doses will be administered via intramuscular (IM) injection. Following confirmation of study eligibility, subjects will be randomized in a 1:1 ratio to receive either a single administration of 0.1 mg of Thyrogen (THYR) or 0.1 mg of the modified release. Randomization will be stratified by whether or not patients will have the thyroid uptake of radioiodine (123I) measured following their single dose of study medication. Five (5) patients in each treatment arm will have uptake measured, while 18 in each arm will not. Each subject will have blood samples taken to determine the pharmacokinetics of serum TSH at -12 hours and just prior to dosing and at various hours up to 14 days following the administration of Thyrogen or the modified release formulation. In addition, for the evaluation of pharmacodynamics, each subject will have samples of blood taken to determine serum free T4, total T4, free T3, and total T3 at -12 hours and just prior to dosing and at various hours up to 14 days following the administration of study treatments. All subjects will undergo a 12-lead electrocardiogram (ECG) just prior to dose administration and 1, 2, 3, 4, 5, 7, 10 and 14 days following study treatment administration. In addition, subjects will undergo 24 hours of Holter monitoring at baseline and four (4) consecutive 24-hour Holter monitoring sessions post treatment to yield a total of 96 hours of continuous monitoring of cardiac function following treatment administration. All subjects will undergo ultrasound evaluations to determine thyroid volume at baseline and 48 hours following treatment administration. Twenty-four hours following the administration of Thyrogen or the modified release formulation, a subset of five (5) subjects in each treatment arm will receive a dose of 123I prepared to be 400µCi on the day of radioiodine administration based on the utilized nuclear pharmacy's calibration schedule. Thyroid gland uptake will be measured via a probe in these 10 subjects at 6, 24 and 48 hours following radioiodine administration. Blood chemistry, complete blood count (CBC), urinalysis and a physical exam will be conducted 14 days after treatment administration, or at the time of early termination, as a final safety assessment. Each subject's duration of study participation will be approximately 4 weeks.
NCT00196729 ↗ Comparison of the Safety and Successful Ablation of Thyroid Remnant in Post-thyroidectomized Euthyroid Patients (i.e. Patients Administered Thyrogen) Versus Hypothyroid Patients (no Thyrogen) Following 131I Administration Completed Genzyme, a Sanofi Company Phase 3 2001-12-01 This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid tissue). One group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine. All patients received the same amount of radioactive iodine (100 mCi or 3.7 GBq of 131I). Approximately 8 months later, whole body scans were performed on all patients to learn whether the thyroid remnants had been successfully ablated. The safety profile of Thyrogen when used for radioiodine remnant ablation also was assessed. The Quality of Life, the radioiodine uptake and retention into the thyroid bed, as well as radiation exposure to the remainder of the body also were assessed in both groups of patients.
NCT00295763 ↗ A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen. Completed Genzyme, a Sanofi Company Phase 3 2006-05-01 Patients diagnosed with thyroid cancer are commonly treated with surgery to remove their thyroid gland followed by radioiodine ablation to destroy any remaining parts of the thyroid gland that may have been missed during surgery. It is thought that ablation with radioiodine destroys normal remaining thyroid tissue as well as cancerous cells either in the thyroid area or at other sites. Following successful treatment, patients are then monitored by their physicians at regular intervals with testing to detect any recurrence of thyroid cancer throughout the body. If thyroid cells are detected by these follow up tests, the physician will decide the best method to re-treat the patient. In 2001-2003 Genzyme conducted a clinical study to test if Thyrogen® can be used to accomplish radioiodine ablation treatment. This study aimed to determine that the success rates of radioiodine ablation were comparable when patients were prepared for ablation with Thyrogen® while being maintained on their normal thyroid hormone therapy, or, alternatively, by thyroid hormone withdrawal. Thyroid hormone withdrawal commonly causes uncomfortable side effects for patients, and these might be avoided by the use of Thyrogen. Eight months after the initial Thyrogen plus radioiodine treatment to achieve ablation, all patients in both groups were given Thyrogen® to test for any remaining thyroid tissue. The results of this testing showed that all patients (in both groups) had successfully achieved remnant ablation and had no detectable thyroid tissue remaining. In order to confirm these remnant ablation results we will conduct follow up testing in this study for all patients that were enrolled in the previous study and we also will determine if their thyroid cancer has recurred. Only patients who completed this previous Thyrogen ablation study are eligible for entry into this study.
NCT00435851 ↗ Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients Unknown status National Cancer Institute, France Phase 3 2007-02-01 In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff. Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.
NCT00435851 ↗ Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients Unknown status Gustave Roussy, Cancer Campus, Grand Paris Phase 3 2007-02-01 In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff. Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Thyrogen

Condition Name

Condition Name for Thyrogen
Intervention Trials
Thyroid Cancer 6
Differentiated Thyroid Cancer 3
Thyroid Neoplasms 2
Stage IVB Follicular Thyroid Cancer 1
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Condition MeSH

Condition MeSH for Thyrogen
Intervention Trials
Thyroid Neoplasms 17
Thyroid Diseases 17
Carcinoma 2
Hypothyroidism 2
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Clinical Trial Locations for Thyrogen

Trials by Country

Trials by Country for Thyrogen
Location Trials
United States 17
Germany 3
France 3
Italy 2
Denmark 1
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Trials by US State

Trials by US State for Thyrogen
Location Trials
Maryland 4
New York 3
Colorado 3
Texas 2
Ohio 2
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Clinical Trial Progress for Thyrogen

Clinical Trial Phase

Clinical Trial Phase for Thyrogen
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Thyrogen
Clinical Trial Phase Trials
Completed 12
Recruiting 3
Active, not recruiting 3
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Clinical Trial Sponsors for Thyrogen

Sponsor Name

Sponsor Name for Thyrogen
Sponsor Trials
Genzyme, a Sanofi Company 4
Memorial Sloan Kettering Cancer Center 3
Gustave Roussy, Cancer Campus, Grand Paris 2
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Sponsor Type

Sponsor Type for Thyrogen
Sponsor Trials
Industry 12
Other 11
NIH 4
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Thyrogen: Clinical Trials, Market Analysis, and Projections

Introduction to Thyrogen

Thyrogen, also known as thyrotropin alfa, is a recombinant form of the human thyroid-stimulating hormone (TSH) used primarily in the management of well-differentiated thyroid cancer. It is manufactured by Sanofi Genzyme and has been a crucial component in the diagnostic and therapeutic protocols for thyroid cancer patients.

Clinical Trials Overview

Diagnostic Use

Thyrogen has been extensively studied in clinical trials for its diagnostic use in patients with well-differentiated thyroid cancer. Two large prospective, randomized phase 3 clinical trials compared Thyrogen to thyroid hormone withdrawal in patients who had undergone near-total thyroidectomy. These studies involved administering Thyrogen as two intramuscular injections of 0.9 mg given 24 hours apart, followed by oral radioiodine and subsequent scanning[1].

  • Study Outcomes: The results showed that Thyrogen was as effective as thyroid hormone withdrawal in preparing patients for diagnostic radioiodine whole-body scans. The studies also highlighted that Thyrogen allowed patients to continue their thyroid hormone replacement therapy without interruption, improving their quality of life[1].

Ablation Success Rates

In addition to diagnostic use, Thyrogen has been evaluated for its role in thyroid remnant ablation. Two large prospective multi-center randomized studies compared the ablation success rates using Thyrogen versus thyroid hormone withdrawal with different doses of radioactive iodine. The studies demonstrated that Thyrogen, when combined with either low-dose or high-dose radioiodine, achieved ablation success rates comparable to those achieved with thyroid hormone withdrawal[1].

  • Long-Term Follow-Up: Long-term follow-up data from these studies showed that the majority of patients had no evidence of cancer recurrence, with a median follow-up period of 5.4 to 6.5 years[1].

Adverse Reactions and Safety Profile

Clinical trials have provided comprehensive data on the safety profile of Thyrogen. Common adverse reactions include insomnia, nausea, fatigue, nasopharyngitis, and anxiety, which were reported in more than 10% of the patients[4].

  • Serious Adverse Events: Although rare, serious adverse events such as thromboembolism, including deep vein thrombosis and pulmonary embolism, have been reported in some patients. These events are critical to monitor, especially in patients with extensive metastases[4].

Market Analysis

Current Market Size and Forecast

The global Thyrogen market was valued at US$ 689 million in 2023 and is projected to reach US$ 852.7 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 3.1% during the forecast period from 2024 to 2030[2][3].

Market Drivers

Several factors are driving the growth of the Thyrogen market:

  • Increasing Incidence of Thyroid Cancer: The rising incidence of thyroid cancer, particularly in regions like the United States, is increasing the demand for effective treatments like Thyrogen[3].
  • Advancements in Treatment Protocols: The flexibility in radioiodine dosing and the ability to continue thyroid hormone replacement therapy without interruption are significant drivers[3].
  • Regulatory Support: FDA approvals and revisions that expand the use of Thyrogen contribute to market growth[3].

Competitive Landscape

Sanofi Genzyme is the primary player in the Thyrogen market, benefiting from exclusive manufacturing rights and regulatory support. However, the market report includes competitor analysis, which may involve other biologic or therapeutic alternatives that could potentially impact the market share of Thyrogen[3].

Market Trends and Forecasts

Technological and Clinical Trends

Advances in biotechnology and clinical practices continue to shape the Thyrogen market. Revised prescribing information and the flexibility in radioiodine dosing reflect ongoing clinical research aimed at improving treatment outcomes. Experts such as Professor Martin Schlumberger and Dr. Ujjal Mallick emphasize the benefits of reduced radioiodine use, especially in low-risk patients[3].

Regional Analysis

The Thyrogen market is segmented by region, with different regions showing varying growth rates. The market report includes detailed regional analysis, highlighting which regions are expected to dominate the global Thyrogen market within the forecast period[5].

SWOT Analysis

A SWOT analysis of the Thyrogen market highlights:

  • Strengths: Exclusive manufacturing rights, critical role in thyroid cancer treatment, and regulatory support.
  • Weaknesses: High development costs, regulatory uncertainties, and potential competition from future biologic alternatives.
  • Opportunities: Increasing incidence of thyroid cancer, advancements in treatment protocols, and expanded use in clinical settings.
  • Threats: High fixed costs of entry for new competitors, potential changes in regulatory environments, and the development of alternative therapies[3].

Key Takeaways

  • The global Thyrogen market is valued at US$ 689 million in 2023 and is expected to reach US$ 852.7 million by 2030.
  • Sanofi Genzyme is the primary player in the market.
  • Thyrogen is used for thyroid remnant ablation and allows patients to continue thyroid hormone replacement therapy.
  • Regulatory updates have expanded the use of Thyrogen.
  • The market is driven by the increasing incidence of thyroid cancer and advancements in treatment protocols.

FAQs

What is Thyrogen used for?

Thyrogen is used as an adjunctive diagnostic tool for well-differentiated thyroid cancer and for thyroid remnant ablation, allowing patients to continue their thyroid hormone replacement therapy without interruption.

What are the common adverse reactions associated with Thyrogen?

Common adverse reactions include insomnia, nausea, fatigue, nasopharyngitis, and anxiety. Serious adverse events such as thromboembolism are rare but critical to monitor.

What is the projected market size of Thyrogen by 2030?

The global Thyrogen market is expected to reach US$ 852.7 million by 2030, growing at a CAGR of 3.1% from 2024 to 2030.

Who is the primary player in the Thyrogen market?

Sanofi Genzyme is the primary player in the Thyrogen market.

What are the key drivers of the Thyrogen market?

The key drivers include the increasing incidence of thyroid cancer, advancements in treatment protocols, and regulatory support.

Cited Sources:

  1. Sanofi: Thyrotropin alfa Lyophilized powder for solution for injection. - Sanofi.
  2. Valuates Reports: Global Thyrogen Market Research Report 2024.
  3. DrugPatentWatch: THYROGEN Drug Profile.
  4. Sanofi: Pr THYROGEN® - Sanofi.
  5. Cognitive Market Research: Thyrogen Market Report 2024 (Global Edition).
Last updated: 2025-01-03

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