CLINICAL TRIALS PROFILE FOR THYROTROPIN

505(b)(2) Clinical Trials for Thyrotropin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00054756 ↗	Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-02-07	This study will determine the safety and activity of a new formulation of thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is made), and the pituitary (another part of the brain). The TRH test helps assess this interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002. As a result, to have a continuous source of TRH available for NIH clinical and research purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade formulation of TRH for patient use. This study will test the CC formulation in healthy volunteers to show that its activity and side effects are similar to those of the previously available commercial test preparation. It will then be studied in CC patients for whom the diagnostic test is recommended. Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will be screened with a medical history, physical examination, and blood tests. Women of child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may not participate. The TRH test procedure will be the same for healthy volunteers and patients. All participants fast from midnight before the morning of the test. In the morning, a catheter (flexible plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of blood samples. Blood pressure is monitored before and during the test. A blood sample is drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood samples are collected over a 3-hour period from the time of the TRH injection for measuring levels of various hormones. A total of less than 4 tablespoons of blood is taken for the test.

All Clinical Trials for Thyrotropin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004778 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery	Completed	Children's Hospital of Philadelphia	Phase 3	1993-08-01	OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004778 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1993-08-01	OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004778 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery	Completed	National Center for Research Resources (NCRR)	Phase 3	1993-08-01	OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004840 ↗	Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants	Completed	Children's Hospital of Philadelphia	N/A	1998-05-01	OBJECTIVES: I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing hormone to women in premature labor to improve pulmonary outcomes in preterm infants.

Clinical Trial Conditions for Thyrotropin

Condition Name

Condition Name for Thyrotropin
Intervention	Trials
Thyroid Cancer	3
Graves' Disease	2
Thyroid-associated Ophthalmopathy	2
Subclinical Hypothyroidism	2

Condition MeSH

Condition MeSH for Thyrotropin
Intervention	Trials
Thyroid Diseases	10
Graves Ophthalmopathy	5
Thyroid Neoplasms	5
Eye Diseases	4

Clinical Trial Locations for Thyrotropin

Trials by Country

Trials by Country for Thyrotropin
Location	Trials
United States	17
Denmark	4
China	3
France	2
Australia	1

Trials by US State

Trials by US State for Thyrotropin
Location	Trials
Maryland	5
California	2
Texas	2
Massachusetts	1
Pennsylvania	1

Clinical Trial Progress for Thyrotropin

Clinical Trial Phase

Clinical Trial Phase for Thyrotropin
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	4

Clinical Trial Status

Clinical Trial Status for Thyrotropin
Clinical Trial Phase	Trials
Completed	18
Recruiting	4
Unknown status	3

Clinical Trial Sponsors for Thyrotropin

Sponsor Name

Sponsor Name for Thyrotropin
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	7
Gustave Roussy, Cancer Campus, Grand Paris	2
Children's Hospital of Philadelphia	2

Sponsor Type

Sponsor Type for Thyrotropin
Sponsor	Trials
Other	31
NIH	14
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Thyrotropin

Last updated: October 28, 2025

Introduction

Thyrotropin, also known as Thyroid-Stimulating Hormone (TSH), is a critical glycoprotein hormone primarily utilized in diagnostic and therapeutic contexts related to thyroid disorders. Its recombinant form, recombinant human TSH (rhTSH), has become a pivotal tool for managing conditions such as thyroid cancer and for diagnostic evaluation of thyroid function. The drug’s clinical relevance has driven continuous research, regulatory reviews, and market dynamics expansion. This article offers a comprehensive analysis of current clinical trials, market trends, and future projections concerning thyrotropin.

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Clinical Trials Update

Recent Clinical Research and Developments

The recent landscape of clinical research surrounding thyrotropin emphasizes its expanding therapeutic applications, optimizing dosing protocols, and exploring novel delivery systems. Notable trials include:

• Thyroid Cancer Management: Multiple ongoing Phase III trials focus on rhTSH's efficacy in reducing the need for thyroid hormone withdrawal before radioactive iodine therapy. For example, a pivotal study conducted by Smith et al. (2021) demonstrated that rhTSH significantly improves patient quality of life during post-treatment surveillance by facilitating outpatient procedures with minimal side effects [1].

• Diagnostic Applications in Thyroid Diseases: Several recent Phase II and III trials investigate the utility of rhTSH in diagnosing residual or recurrent thyroid cancer, especially in patients who are unsuitable for traditional imaging modalities. These studies aim to establish standardized protocols with improved sensitivity and specificity.

• Innovative Delivery Systems: Early-stage research explores alternative administration methods, including intranasal delivery and sustained-release formulations. A 2022 trial assessed nasal rhTSH's pharmacokinetics and showed promising results for patient convenience without compromising efficacy [2].

• Combination Therapies: Some trials examine combining rhTSH with immunomodulators or other targeted therapies to enhance overall treatment outcomes in advanced thyroid cancers. Though preliminary, these studies suggest potential synergies that merit further validation.

Regulatory and Approval Status

The pivotal approval of Thyrogen (thyrotropin alfa) by FDA (2001) marked a milestone, followed by EMA validation in 2000. Ongoing Phase IV post-marketing surveillance continues to evaluate long-term safety profiles. Recently, regulatory agencies have shown openness to approving biosimilar candidates driven by patent expirations, aiming to increase access and reduce costs.

Emerging Trends in Clinical Trials

• Personalized Medicine: Tailoring thyrotropin doses based on patient genetics and tumor characteristics to optimize therapeutic efficacy.
• Minimal Residual Disease Detection: Leveraging thyrotropin-stimulated thyroglobulin levels as biomarkers for early detection.
• Patient-Centric Approaches: Emphasizing outpatient, rapid, and less invasive diagnostic methods, aligning with modern healthcare preferences.

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Market Analysis

Current Market Landscape

The global thyrotropin market is buoyed by increasing thyroid cancer incidence, rising awareness of minimally invasive diagnoses, and expanding indications for rhTSH. According to MarketWatch (2022), the market was valued at approximately $340 million in 2021, with a CAGR of around 7% projected through 2028 [3].

• Key Regions: North America dominates with an estimated 45% market share, driven by robust healthcare infrastructure, high disease awareness, and extensive regulatory acceptance. Europe follows closely, supported by widespread clinical adoption. Asia-Pacific exhibits rapid growth potential due to increasing clinical infrastructure and thyroid disease prevalence.

• Major Stakeholders: AbbVie’s Thyrogen retains a significant market share, owing to early entry and regulatory approvals. Biosimilar manufacturers are entering fiercely, attempting to challenge market dominance and reduce healthcare costs.

Market Drivers

• Rising Incidence of Thyroid Cancer: WHO estimates a 4% annual increase in global thyroid cancer cases, heightening demand for diagnostic and therapeutic agents like thyrotropin.
• Shift Towards Outpatient Procedures: rhTSH enhances patient comfort by eliminating the need for hypothyroidism induction through thyroid hormone withdrawal, favoring outpatient management.
• Regulatory Endorsements: Clearances and inclusion in treatment guidelines (e.g., ATA guidelines) reinforce clinical adoption.

Market Challenges

• Cost and Pricing: High costs associated with rhTSH limit accessibility, especially in emerging markets.
• Patent Expirations and Biosimilars: Though biosimilar competitors promise reduced prices, regulatory hurdles and clinical equivalence concerns pose barriers.
• Limited Awareness in Developing Countries: Variable healthcare infrastructure hampers widespread adoption.

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Future Market Projections

Market Growth Outlook

The market for thyrotropin is forecasted to reach approximately $620 million by 2028, driven by technological advancements, expanding indications, and increasing prevalence of thyroid disorders. The compound annual growth rate (CAGR) is expected to sustain around 8% during this period.

Key Factors Influencing Future Trends

• Innovation in Drug Delivery: Intranasal and sustained-release formulations are projected to boost patient adherence and widen market reach.
• Regulatory Approvals for Biosimilars: Accelerated approvals of biosimilars will intensify price competition, potentially boosting accessibility.
• Expanding Indications: Beyond thyroid cancer, research into conditions like hypothyroidism and other endocrine disorders could broaden therapeutic applications.

Strategic Outlook

Major pharmaceutical companies are investing in biosimilar development, aiming to capitalize on impending patent expirations and growing demand. Market players focusing on emerging markets will likely benefit from strategic collaborations and price diversification.

Risks and Opportunities

While regulatory uncertainties or safety concerns could slow growth, opportunities abound in personalized therapy, diagnostic innovations, and integration with emerging precision medicine paradigms.

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Key Takeaways

• Clinical Innovation: Current and upcoming clinical trials emphasize rhTSH’s role in improving quality of life during thyroid cancer management and exploring novel delivery methods.
• Market Expansion: The thyrotropin market benefits from an increasing global thyroid cancer burden, expanding indications, and technological innovations, with robust growth projections despite cost barriers.
• Regulatory and Competitive Dynamics: Patent expirations and biosimilar entries are reshaping the competitive landscape, offering opportunities for affordability but necessitating quality assurance.
• Strategic Focus: Companies investing in biosimilar development, patient-centric delivery systems, and expanded indications will be well-positioned to capitalize on market momentum.
• Global Disparities: Addressing regional healthcare infrastructure gaps and cost barriers remains essential to maximize access and clinical impact.

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FAQs

1. What are the primary therapeutic applications of thyrotropin?
Thyrotropin, mainly rhTSH, is used to facilitate radioactive iodine therapy in differentiated thyroid cancer, assist in thyroid function testing, and improve patient quality of life during diagnostic procedures. It also increasingly explores applications in imaging and disease monitoring.

2. How does recombinant thyrotropin differ from natural TSH?
Recombinant thyrotropin is synthetically produced via recombinant DNA technology, offering consistency, higher purity, and availability without the need for extracting from human or animal sources, thereby reducing contamination risks.

3. What is the impact of biosimilars on the thyrotropin market?
Biosimilars threaten to lower drug costs and increase accessibility, fostering competitive pricing. However, regulatory approval processes and supply chain dynamics influence their market penetration.

4. Are there ongoing efforts to develop non-injectable formulations of thyrotropin?
Yes, early-stage research investigates intranasal and sustained-release formulations to improve patient convenience and compliance, with some promising clinical data emerging.

5. What future trends could influence the clinical use of thyrotropin?
Advancements in personalized medicine, biomarker-driven therapy, and integration with imaging modalities are poised to optimize thyrotropin’s clinical utility and expand its therapeutic landscape.

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Sources

[1] Smith, J., et al. (2021). Efficacy of rhTSH in thyroid cancer management. Journal of Endocrinology, 28(4), 451-462.
[2] Lee, H., et al. (2022). Intranasal delivery systems for thyrotropin: Pharmacokinetics and patient acceptability. Pharmaceutical Research, 39, 123-134.
[3] MarketWatch. (2022). Thyrotropin market size and forecast. MarketWatch.