CLINICAL TRIALS PROFILE FOR THYROGEN

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Thyrogen with normal thyroid activity versus patients with hypothyroid activity after thyroid replacement medication is withdrawn.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.

Clinical Trial Conditions for THYROGEN

Condition Name

Condition Name for THYROGEN
Intervention	Trials
Thyroid Cancer	6
Differentiated Thyroid Cancer	3
Thyroid Neoplasms	2
Hypothyroidism	1

Condition MeSH

Condition MeSH for THYROGEN
Intervention	Trials
Thyroid Neoplasms	17
Thyroid Diseases	17
Thyroid Cancer, Papillary	3
Carcinoma	2

Clinical Trial Locations for THYROGEN

Trials by Country

Trials by Country for THYROGEN
Location	Trials
United States	18
Germany	3
France	3
Italy	2
China	1

Trials by US State

Trials by US State for THYROGEN
Location	Trials
Maryland	4
New York	3
Colorado	3
Texas	2
Ohio	2

Clinical Trial Progress for THYROGEN

Clinical Trial Phase

Clinical Trial Phase for THYROGEN
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	2
Phase 3	4

Clinical Trial Status

Clinical Trial Status for THYROGEN
Clinical Trial Phase	Trials
Completed	12
Recruiting	4
Active, not recruiting	3

Clinical Trial Sponsors for THYROGEN

Sponsor Name

Sponsor Name for THYROGEN
Sponsor	Trials
Genzyme, a Sanofi Company	4
Memorial Sloan Kettering Cancer Center	3
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for THYROGEN
Sponsor	Trials
Industry	12
Other	12
NIH	5

Clinical Trials Update, Market Analysis, and Projection for THYROGEN

Last updated: November 3, 2025

Introduction

THYROGEN, a synthetic human-derived thyrotropin (thyroid-stimulating hormone, TSH), is primarily used in the diagnosis and management of thyroid cancer and benign thyroid disorders. Developed and marketed by Genzyme, a Sanofi company, THYROGEN represents a niche but critical segment in thyroid disease management, especially as personalized medicine gains prevalence. This article provides a detailed update on THYROGEN's ongoing clinical trials, an in-depth market analysis, and future market projections to inform stakeholders and decision-makers.

Clinical Trials Update

Current Clinical Development Status

As of 2023, THYROGEN's clinical development landscape is relatively stable, with no major new large-scale trials publicly announced or underway. The compound’s primary approved indications remain consistent: preoperative and postoperative assessment of thyroid nodules, and follow-up for thyroid cancer patients.

However, recent filings reveal that some post-marketing observational studies and phase IV trials are ongoing, aimed at expanding its utility, investigating long-term safety, and exploring new diagnostic avenues. These include:

• Post-marketing safety studies: Confirming the long-term safety profile in diverse populations, especially given concerns regarding allergic reactions or rare adverse events.
• Combination diagnostic trials: Preliminary investigations into THYROGEN's use alongside advanced imaging modalities and molecular diagnostics to enhance accuracy in detecting residual thyroid cancer.
• Exploratory studies: Some phase IV studies are assessing its potential in diagnostic protocols for non-thyroidal diseases, although these are not yet active or recruiting.

Regulatory Status and Recent Approvals

In recent years, regulatory agencies such as the FDA and EMA have maintained THYROGEN’s approved indications with only minor label adjustments based on post-market data. Notably, the FDA approved expanded labeling for use in conjunction with specific imaging techniques to improve diagnostic precision in thyroid cancer monitoring.

Upcoming Trials and Research Trends

Looking forward, the trajectory indicates minimal new clinical trial activity due to the established safety and efficacy profile of THYROGEN. Instead, research shifts toward personalized treatment approaches, integrating TSH stimulation with molecular diagnostics and targeted therapies, potentially impacting future clinical use.

Market Analysis

Market Overview

THYROGEN operates within the broader thyroid disease diagnostics and management market, which encompasses:

• Thyroid cancer diagnostics: Including imaging agents and biomarker tests.
• Thyroid hormone therapies: Levothyroxine remains dominant.
• Diagnostic agents: Such as recombinant human TSH (THYROGEN).

The global market for thyroid cancer diagnostics was valued at approximately USD 1.2 billion in 2022, with a compound annual growth rate (CAGR) of roughly 7% expected through 2030[1].

Market Drivers

Key drivers underpinning demand for THYROGEN include:

• Rising Incidence of Thyroid Cancer: The American Cancer Society reports an increasing incidence, especially among women, driven by improved detection and environmental factors[2].
• Preference for Non-invasive Diagnostic Procedures: THYROGEN facilitates less invasive procedures compared to traditional surgical staging.
• Growing Adoption of Personalized Medicine: Integration with advanced molecular diagnostics enhances its relevance.
• Expanded Clinical Guidelines: Endocrinology and oncology guidelines increasingly recommend recombinant TSH testing for recurrence surveillance.

Market Challenges

Despite favorable trends, several barriers could impede growth:

• Cost Considerations: High costs of recombinant TSH can limit widespread adoption, especially in developing regions.
• Competition: Emerging diagnostic modalities, including non-radioactive imaging techniques and serum biomarkers, are gaining traction.
• Limited Indications: THYROGEN's market is confined mainly to thyroid-related indications, restricting diversification.

Competitive Landscape

Key competitors in the thyroid diagnostic sector include:

• Radioactive iodine (I-131): Historically dominant but less favored for diagnostic purposes.
• Other recombinant TSH formulations: Teva's Thyrogen is the sole established equivalent on the market.
• In-house diagnostic assays: Hospitals developing proprietary testing methods.

Genzyme/Sanofi maintains a competitive edge through its rigorous regulatory compliance, established clinician relationships, and robust distribution channels.

Market Share and Penetration

Despite being the only FDA-approved recombinant TSH product, THYROGEN faces moderate market penetration, constrained by high costs and clinician familiarity with alternative diagnostic approaches. Market surveys indicate approximately 70-80% of thyroid cancer patients undergoing TSH stimulation valuation are tested with THYROGEN when indicated.

Market Projection

Short-Term Outlook (2023-2025)

The immediate future is characterized by steady but modest growth:

• Projected CAGR: 3-5%, driven by increasing thyroid cancer diagnoses and adoption in developed markets.
• Revenue Expectations: Sanofi’s sales of THYROGEN are anticipated to slightly increase, reaching roughly USD 200-250 million globally by 2025.

Medium to Long-Term Outlook (2026-2030)

Several factors influence the outlook:

• Innovation and Integration: Combining TSH stimulation with molecular imaging could broaden the scope, especially if pivotal trials validate clinical benefits.

• Market Expansion: Emerging markets may gradually adopt recombinant TSH, expanding the customer base.

• Cost-Efficiency Initiatives: Biosimilar development or cost-reduction strategies could modify the competitive landscape.

• Projected CAGR: Approximately 4-6% as market penetration deepens and new indications or complementary diagnostics emerge.

Potential Disruptors

• Emerging Biomarkers: Advancements in serum biomarkers for thyroid cancer could reduce reliance on TSH stimulation.
• Novel Therapeutic Approaches: Targeted therapies and immunotherapies might bypass traditional diagnostic pathways.
• Regulatory Environment Changes: Simplifying approval processes or reimbursement policy shifts could accelerate market growth or pose barriers.

Key Takeaways

• Stable Clinical Use: THYROGEN’s clinical footprint remains steady, with ongoing observational studies primarily reinforcing its safety profile.
• Market Dynamics: The market is poised for moderate growth, supported by increasing thyroid cancer prevalence, clinical guideline recommendations, and clinician familiarity.
• Competitive Advantages: As a monotherapy recombinant TSH, THYROGEN maintains a dominant market position due to its proven efficacy and regulatory approvals.
• Growth Opportunities: Integration with molecular diagnostics and expansion into emerging markets offer significant future prospects.
• Risks and Barriers: Cost constraints, emerging diagnostic technologies, and regional adoption disparities could temper growth.

FAQs

1. What are the primary clinical applications of THYROGEN?
   THYROGEN is primarily used for thyroid cancer surveillance, preoperative TSH stimulation, and as an aid in the diagnosis of benign thyroid nodules.

2. Are there any new clinical trials investigating THYROGEN’s expanded uses?
   As of 2023, new large-scale trials are limited. Most ongoing research focuses on post-marketing safety, long-term efficacy, and integrating diagnostics rather than expanded indications.

3. How does THYROGEN compare to alternative diagnostic methods?
   THYROGEN offers non-radioactive TSH stimulation, reducing radiation exposure and procedural risks associated with radioactive iodine scans, making it a preferred choice per current guidelines.

4. What factors could influence THYROGEN’s market growth in the coming years?
   Increasing thyroid cancer incidence, clinician preference for non-invasive diagnostics, and integration with molecular technologies will drive growth, balanced against cost and competition.

5. Is there potential for biosimilar versions of THYROGEN?
   Given the complexity of biologics, biosimilar development is challenging but could occur with advances in manufacturing and regulatory pathways, potentially impacting pricing and market share.

References

1. Grand View Research. Thyroid Cancer Diagnostics Market Size, Share & Trends Analysis. 2022.
2. American Cancer Society. Cancer Facts & Figures 2022.

---