CLINICAL TRIALS PROFILE FOR EUTHYROX

All Clinical Trials for EUTHYROX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01379170 ↗	Thyroid Study Type 2 Diabetes Mellitus (T2DM)	Unknown status	Maastricht University Medical Center	Phase 4	2011-06-01	Background of the study: Thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to promote weight loss, which could be beneficial for treating obesity, and type 2 diabetes. Thyroid hormone treatment stimulates energy expenditure resulting in increased body heat production, in which brown adipose tissue play an important role. It is hypothesized that thyroid hormones would induce increased energy expenditure via a process called mitochondrial uncoupling, thereby creating an inefficient energy status. Indeed, an in vivo study showed a 70% increased flux through the tricarboxylic acid cycle (TCA) and an unchanged ATP synthesis rate upon T3 treatment in lean, healthy young men. The disproportionate increase in TCA flux compared with ATP synthesis suggests increased mitochondrial uncoupling. It is however unknown whether increased mitochondrial uncoupling would increase fat oxidation and exerts favorable effects on insulin sensitivity. There is compelling evidence that type 2 diabetic patients have high levels of fat accumulation in non-adipose tissues, such as skeletal muscle, heart and liver. Ectopic fat accumulation is related to insulin resistance, however, why this fat accumulates in peripheral organs is not known. Recently, studies reported compromised mitochondrial oxidative capacity in type 2 diabetic patients and first-degree relatives of diabetic patients, suggested to play an important role. Therefore, subjects suffering from overweight and/or type 2 diabetes with overt hypothyroidism form an interesting group for examining the metabolic effects of thyroid hormone treatment, as less is known about the effects of thyroid hormone treatment in these groups. Objective of the study: The purpose of this study is to evaluate whether thyroid hormone replacement therapy in type 2 diabetic patients suffering from overt hypothyroidism, will improve muscular mitochondrial function, lower ectopic fat accumulation in muscle and liver, increase brown adipose tissue activity and enhance insulin sensitivity. Study design: Type 2 diabetic patients diagnosed with hypothyroidism will undergo 3 months of thyroid hormone replacement therapy (THRT) (Euthyrox®, Merck, Germany). Patients will be metabolically characterized (such as insulin sensitivity and fat accumulation in peripheral tissues) before and after this thyroid hormone replacement therapy. Study population: 17 type 2 diabetic patients diagnosed with overt hypothyroidism (9 from the Netherlands, 8 from Germany which will only do the PET-CT) Primary study parameters/outcome of the study: Thyroid hormone-induced change in whole body insulin sensitivity (change in insulin-stimulated glucose disposal) and muscle mitochondrial function. Secondary study parameters/outcome of the study (if applicable): Thyroid hormone-induced change of lipid content in skeletal muscle and liver and brown adipose tissue activity.
NCT01458600 ↗	Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)	Completed	Mikael Lantz	Phase 4	2006-09-01	AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms and eye protrusion. Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of ophthalmopathy. Specific aims: 1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months treatment with or without diclofenac. 2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy after 12 months treatment with or without diclofenac. 3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months treatment with or without diclofenac. Study plan and randomisation - 150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18 months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12 months.
NCT01848171 ↗	Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism	Active, not recruiting	Shandong Provincial Hospital	Phase 4	2013-07-01	Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.
NCT02512978 ↗	Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)	Unknown status	Beijing Anzhen Hospital	Phase 4	2015-08-01	Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.
NCT02512978 ↗	Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)	Unknown status	Beijing Chao Yang Hospital	Phase 4	2015-08-01	Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.
NCT02512978 ↗	Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)	Unknown status	Beijing Friendship Hospital	Phase 4	2015-08-01	Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.
NCT02512978 ↗	Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)	Unknown status	Beijing Municipal Science & Technology Commission	Phase 4	2015-08-01	Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.

Clinical Trial Conditions for EUTHYROX

Condition Name

Condition Name for EUTHYROX
Intervention	Trials
Hypothyroidism	3
Subclinical Hypothyroidism	2
Intracerebral Hemorrhage	1
Low T3 Syndrome	1

Condition MeSH

Condition MeSH for EUTHYROX
Intervention	Trials
Hypothyroidism	5
Graves Ophthalmopathy	1
Heart Failure	1
Graves Disease	1

Clinical Trial Locations for EUTHYROX

Trials by Country

Trials by Country for EUTHYROX
Location	Trials
China	5
Sweden	1
Netherlands	1

Clinical Trial Progress for EUTHYROX

Clinical Trial Phase

Clinical Trial Phase for EUTHYROX
Clinical Trial Phase	Trials
Phase 4	6
Phase 1	1
NA	1

Clinical Trial Status

Clinical Trial Status for EUTHYROX
Clinical Trial Phase	Trials
Unknown status	3
Completed	2
Not yet recruiting	2

Clinical Trial Sponsors for EUTHYROX

Sponsor Name

Sponsor Name for EUTHYROX
Sponsor	Trials
Peking Union Medical College Hospital	2
The Luhe Teaching Hospital of the Capital Medical University	2
Chinese Academy of Medical Sciences, Fuwai Hospital	2

Sponsor Type

Sponsor Type for EUTHYROX
Sponsor	Trials
Other	22
Industry	1

Clinical Trials Update, Market Analysis, and Projection for EUTHYROX

Last updated: November 2, 2025

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Introduction

EUTHYROX (liothyronine sodium) remains a cornerstone therapy for hypothyroidism, particularly in patients with refractory or complex cases. As a synthetic form of the active thyroid hormone triiodothyronine (T3), EUTHYROX plays an integral role in thyroid hormone replacement therapy. The landscape for thyroid medications is evolving with recent clinical trials, market dynamics, and regulatory developments shaping its future trajectory. This comprehensive analysis examines the current clinical trial landscape, conducts a detailed market assessment, and offers projections grounded in contemporary data.

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Clinical Trials Update

Recent clinical investigations centered on EUTHYROX underscore its ongoing significance, especially in personalized hypothyroidism management and off-label applications.

Key Ongoing and Recent Trials

• Optimization in Hypothyroidism: Multiple phase II and III trials focus on optimizing dosing regimens, especially combining EUTHYROX with levothyroxine. Studies such as NCT04592716 evaluate the safety and efficacy of liquid liothyronine formulations in patients inadequately managed with levothyroxine alone [1].

• Refractory Hypothyroidism and Cardiovascular Outcomes: NCT04222727 explores long-term cardiovascular outcomes associated with liothyronine therapy, addressing safety concerns that have historically limited its use [2].

• Personalized Therapy Approaches: A series of trials are investigating genetic markers influencing response to T3 therapy, aligning with precision medicine trends. These studies aim to establish tailored dosing protocols, with some using pharmacogenomics to predict optimal therapy.

Regulatory and Approval Developments

• FDA and EMA Oversight: Recent submissions for New Drug Applications (NDAs) for liquid formulations aim to improve bioavailability and compliance, particularly in patients with malabsorption syndromes.

• Post-Marketing Surveillance: Ongoing safety monitoring continues to affirm the drug's profile, with particular attention to cardiac events and thyrotoxic symptoms in vulnerable populations.

Implication of Clinical Data

The accumulation of robust safety and efficacy data supports tailored approaches, emphasizing liothyronine as an adjunct or alternative to standard therapy in select patient groups. These trials bolster confidence in its utility, setting a foundation for expanded indications pending regulatory review.

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Market Analysis

Historical Context and Current Market Size

EUTHYROX has maintained a steady market presence since its introduction, particularly in North America, Europe, and emerging markets. The global thyroid hormone replacement marketwas valued at approximately USD 600 million in 2022[3], with EUTHYROX accounting for a significant share due to its unique position as the only authorized liothyronine product in several jurisdictions.

Drivers of Market Growth

• Rising Prevalence of Hypothyroidism: According to the American Thyroid Association, hypothyroidism affects about 4.6% of the U.S. population aged 12 and over[4].

• Demand for Personalized Medicine: The trend towards individualized therapy increases demand for T3-based formulations like EUTHYROX, especially among patients dissatisfied with levothyroxine monotherapy.

• Enhancements in Formulation and Delivery: The development of liquid and controlled-release formulations enhances patient compliance and broadens therapeutic options, stimulating market growth.

Competitive Landscape

Primary competitors include generic levothyroxine products, with liothyronine (EUTHYROX) often positioned as an adjunctive therapy. Key players and product availability vary regionally, with some markets lacking equivalent T3 formulations owing to regulatory hurdles or patent constraints.

Challenges and Barriers

• Safety Concerns: The potential for inducing hyperthyroidism limits widespread use, particularly in high-risk populations.

• Regulatory Hurdles: Variability in approval status influences market penetration; in some regions, regulatory restrictions limit indications for liothyronine.

• Cost and Reimbursement: Higher costs compared to levothyroxine pose access barriers, especially where reimbursement policies are unfavorable.

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Market Projection

Forecast for 2023–2030

Considering current trends, the EUTHYROX market is projected to experience compound annual growth rates (CAGRs) of approximately 6-8%, driven by clinical validation, regulatory approvals, and increased clinician awareness.

• Regional Growth Dynamics

  • North America and Europe are expected to retain leading markets due to existing infrastructure, regulatory acceptance, and high hypothyroid prevalence.

  • Emerging markets in Asia-Pacific and Latin America are anticipated to demonstrate robust growth, fueled by increasing healthcare access and rising diagnosis.

• Pipeline and Innovation Impact

  • Introduction of novel formulations and combination therapies could augment sales, possibly escalating CAGR up to 10% in high-growth segments.

• Regulatory Expansion Prospects

  • Pending approval of newer formulations and expanded indications could double the addressable market size by 2030 [5].

Market Risks

• Uncertainties stem from safety concerns, regulatory delays, and competitive pressures from emerging generic and biosimilar products.

• The evolving understanding of hypothyroidism management may shift preference away from T3 monotherapy in standardized treatment protocols, slightly tempering growth forecasts.

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Strategic Outlook

For pharmaceutical companies and investors, EUTHYROX remains a promising segment within the endocrine therapeutics space. Emphasizing clinical research that demonstrates safety and efficacy, coupled with formulation innovations, will be critical to capturing market share and expanding indications.

Companies should monitor regulatory landscapes globally to anticipate approval timelines, particularly where off-label use currently dominates. Strategic partnerships and investments in personalized medicine initiatives will position stakeholders to leverage emerging clinical insights.

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Key Takeaways

• Clinical Validation Is Building: Ongoing trials substantiate EUTHYROX’s role in personalized hypothyroid management and verify its safety profile, especially with optimized dosing regimens.

• Market Opportunities Are Expanding: Increasing hypothyroidism prevalence, improved formulations, and emerging markets are expected to drive growth, with projections indicating a CAGR of 6-8% through 2030.

• Regulatory Developments Are Pivotal: Approval of novel formulations and expanded indications can significantly impact market size and accessibility.

• Safety Concerns Continue to Influence Use: Despite positive data, cautious clinician adoption persists due to potential adverse effects.

• Innovation and Personalization Will Lead: Tailored therapeutic approaches and pharmacogenetic insights are poised to redefine liothyronine’s role.

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FAQs

1. What are the recent advancements in liothyronine formulations?
Recent developments include liquid formulations that improve bioavailability and ease of dosing, with some formulations designed for controlled or sustained release, enhancing patient adherence and safety [1].

2. How does EUTHYROX compare to levothyroxine in hypothyroidism management?
EUTHYROX provides active T3 hormone, potentially offering faster symptom relief and better regulation in certain cases, particularly refractory hypothyroidism. However, it carries risks of hyperthyroidism and requires careful monitoring, making it primarily an adjunct rather than a first-line therapy.

3. What are the key safety concerns associated with EUTHYROX?
The main risks involve inducing hyperthyroidism, arrhythmias, and cardiovascular strain, especially in older or vulnerable patients. Proper dose titration and monitoring mitigate these risks.

4. What is the regulatory status of EUTHYROX globally?
EUTHYROX is approved in various countries, including the U.S. and European nations, primarily for hypothyroidism. Some regions face regulatory barriers due to safety concerns or limited clinical data, affecting broader approval.

5. How might emerging clinical trial data influence EUTHYROX's market future?
Positive trial outcomes demonstrating safety, efficacy, and targeted use cases will likely strengthen regulatory support and clinician confidence, expanding indications and increasing market penetration.

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References

[1] ClinicalTrials.gov. “Evaluation of Liquid Liothyronine in Hypothyroid Patients,” NCT04592716.
[2] ClinicalTrials.gov. “Long-term Cardiovascular Outcomes with Liothyronine,” NCT04222727.
[3] MarketWatch. “Global Thyroid Hormone Replacement Market Size,” 2022.
[4] American Thyroid Association. “Hypothyroidism Statistics and Facts,” 2021.
[5] EvaluatePharma. “Pharmaceutical Market Trends and Projections,” 2023.

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In Summary, EUTHYROX’s clinical development trajectory, coupled with expanding indications and formulations, positions it as a vital player within the hypothyroid treatment landscape. Ongoing research and regulatory evolution will shape its market share and clinical utility through the next decade.