CLINICAL TRIALS PROFILE FOR LIOTHYRONINE SODIUM

All Clinical Trials for liothyronine sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004062 ↗	Azacitidine to Restore Thyroid Function in Patients With Persistent or Metastatic Thyroid Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1999-07-01	RATIONALE: Azacitidine may help thyroid cancer cells regain the ability to take up iodine. This would allow the cancer to be detected and treated by radioactive iodine. PURPOSE: Phase I trial to study the effectiveness of azacitidine to restore thyroid function in treating patients who have persistent or metastatic thyroid cancer.
NCT00004062 ↗	Azacitidine to Restore Thyroid Function in Patients With Persistent or Metastatic Thyroid Cancer	Completed	Lucille P. Markey Cancer Center at University of Kentucky	Phase 1	1999-07-01	RATIONALE: Azacitidine may help thyroid cancer cells regain the ability to take up iodine. This would allow the cancer to be detected and treated by radioactive iodine. PURPOSE: Phase I trial to study the effectiveness of azacitidine to restore thyroid function in treating patients who have persistent or metastatic thyroid cancer.
NCT00027417 ↗	Study of Triostat in Infants During Heart Surgery	Completed	Michael Portman	Phase 3	2001-04-01	This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.
NCT00098852 ↗	Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer	Unknown status	National Cancer Institute (NCI)	Phase 2	2004-10-01	RATIONALE: Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive iodine. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer.
NCT00098852 ↗	Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer	Unknown status	University of California, San Francisco	Phase 2	2004-10-01	RATIONALE: Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive iodine. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer.
NCT00311987 ↗	Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients	Terminated	Johns Hopkins University	Phase 1/Phase 2	2006-04-01	The natural thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to have a cholesterol-lowering effect. Their pharmacologic use for this purpose is limited, however, by their actions on other organs, including the heart, bone, and brain, where there can be side effects of excessive thyroid hormone action. 3,5-diiodothyropropionic acid (DITPA) is a thyroid hormone analog with relative selectivity for a form of the thyroid hormone receptor expressed in the liver, where it regulates several aspects of lipid metabolism, including the clearance of low-density lipoprotein (LDL) cholesterol. This study is designed to determine whether DITPA is safe and effective in achieving LDL cholesterol levels that are consistent with the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines in patients who have not achieved those levels on conventional therapy, due to drug-resistant disease, drug intolerance, or both. This is a single-center, randomized, double-blind, placebo-controlled study. Following a 4-week Pre-Randomization Phase with dietary counseling and a 2-week placebo run-in, eligible patients will be randomized (1:1:1) to receive DITPA (90 mg/day, 180 mg/day), or placebo for a total treatment duration of 12 weeks. Sixty (60) patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 20 patients per treatment group): - DITPA at 90 mg/day (45 mg twice a day [BID] taken orally) - DITPA at 180 mg/day (90 mg BID taken orally) - Placebo (BID taken orally) Those patients randomized to receive DITPA at 90 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for 10 weeks. Those patients randomized to receive DITPA at 180 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for the next 2 weeks, and then 180 mg/day for 8 weeks.
NCT00788307 ↗	Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy	Terminated	National Cancer Institute (NCI)	Phase 1	2008-11-03	RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer cells may help the prostate cells take in more radioactive iodine and thus kill the cancer cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of radioactive iodine. PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given together with radioactive iodine in treating patients with locally recurrent prostate cancer that did not respond to external-beam radiation therapy.

Clinical Trial Conditions for liothyronine sodium

Condition Name

Condition Name for liothyronine sodium
Intervention	Trials
Head and Neck Cancer	2
Healthy	2
Thyroid	1
Hypercholesterolemia	1

Condition MeSH

Condition MeSH for liothyronine sodium
Intervention	Trials
Thyroid Diseases	4
Thyroid Neoplasms	3
Head and Neck Neoplasms	2
Heart Defects, Congenital	2

Clinical Trial Locations for liothyronine sodium

Trials by Country

Trials by Country for liothyronine sodium
Location	Trials
United States	14
Korea, Republic of	1
Indonesia	1

Trials by US State

Trials by US State for liothyronine sodium
Location	Trials
District of Columbia	2
Minnesota	2
Maryland	2
California	2
Washington	2

Clinical Trial Progress for liothyronine sodium

Clinical Trial Phase

Clinical Trial Phase for liothyronine sodium
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	4
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for liothyronine sodium
Clinical Trial Phase	Trials
Completed	9
Terminated	2
Unknown status	2

Clinical Trial Sponsors for liothyronine sodium

Sponsor Name

Sponsor Name for liothyronine sodium
Sponsor	Trials
National Cancer Institute (NCI)	4
Ipe, LLC	2
Mayo Clinic	1

Sponsor Type

Sponsor Type for liothyronine sodium
Sponsor	Trials
Other	14
Industry	4
NIH	4

Liothyronine Sodium: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Liothyronine Sodium, a synthetic form of the thyroid hormone triiodothyronine (T3), plays a critical role in managing hypothyroidism and certain thyroid cancer treatments. As the landscape of thyroid disorder therapeutics evolves, the demand for Liothyronine Sodium remains a key focus for pharmaceutical companies, healthcare providers, and investors. This article provides a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and offers future projections for Liothyronine Sodium over the coming years.

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Clinical Trials Update

Current Clinical Trial Landscape

The clinical development activities surrounding Liothyronine Sodium predominantly involve its repurposing, formulation improvements, and safety profiling. As of early 2023, there are approximately 10 active clinical trials worldwide, primarily registered on ClinicalTrials.gov and other regional platforms.

Key Trials and Focus Areas

• Bioequivalence and Formulation Optimization: Several trials aim to compare novel sustained-release formulations of Liothyronine Sodium to improve patient compliance and maintain steady serum T3 levels. These studies often involve crossover designs with endpoints assessing pharmacokinetics (PK), pharmacodynamics (PD), and safety profiles [1].

• Combination Therapy Studies: Investigations explore the combined use of Liothyronine Sodium with levothyroxine (T4) to optimize thyroid hormone replacement, especially for patients with refractory hypothyroidism. Trials focus on dosing regimens, symptom relief, and metabolic parameters [2].

• Safety and Long-term Outcomes: Extended studies assess the long-term safety of Liothyronine Sodium, including cardiovascular risks, bone density effects, and mood-related side effects, given its potent T3 activity [3].

• Special Populations: Trials targeting pediatric patients, pregnant women, and individuals with comorbidities address pharmacokinetic variations and dosing safety, ensuring broader applicability [4].

Recent Outcomes and Regulatory Advances

While most clinical trials validate the efficacy of Liothyronine Sodium in hypothyroid management, regulatory agencies such as the FDA have highlighted challenges regarding its narrow therapeutic index. Recent approvals or amendments favoring specific formulations—like sustained-release variants—signal improved safety margins and patient adherence [5].

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Market Analysis

Current Market Size and Segmentation

The Liothyronine Sodium market was valued at approximately $250 million in 2022, with steady growth driven by the prevalence of hypothyroidism, estimated at about 4.6% of the U.S. population [6]. Key segments include:

• Pharmaceutical Formulations: Tablets, compounded formulations, and investigational sustained-release products.
• End-User Markets: Hospitals, specialty clinics, and outpatient pharmacies.
• Geographic Regions: North America retains the largest share, followed by Europe and Asia-Pacific, where rising healthcare infrastructure boosts demand.

Market Drivers

• Growing Prevalence of Thyroid Disorders: An aging global population, increased screening, and heightened awareness contribute to rising prescription volumes.
• Shift Toward Personalized Therapy: Advances in pharmacogenomics favor tailored thyroid hormone replacement, benefiting Liothyronine Sodium's niche applications.
• Regulatory and Manufacturing Changes: Moves toward standardized manufacturing processes and quality controls enhance product reliability, encouraging clinician adoption.

Competitive Landscape

Major players include:

• CNH Specialty Care GmbH (German origin companies)
• Avrio Health LLC
• KapiPharma
• Others focusing on compounded formulations

Emerging entrants developing sustained-release and combination therapies pose competitive threats, aiming to capture market share through innovative delivery systems.

Market Challenges

• Safety Concerns: Narrow therapeutic window heightens scrutiny over side effects, influencing prescribing practices.
• Availability of Alternatives: Levothyroxine remains the first-line treatment, with Liothyronine often reserved for specific cases, limiting broader market penetration.

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Future Market Projection

Forecast Overview (2023–2030)

Analysts project the Liothyronine Sodium market will grow at a compound annual growth rate (CAGR) of approximately 4–6% through 2030, driven by disease prevalence, formulation innovation, and expanding regulatory approvals.

Key Growth Factors

• Innovation in Delivery: Sustained-release and transdermal formulations could revolutionize administration, improving patient adherence and safety profiles.
• Global Expansion: Emerging markets in Asia-Pacific, Latin America, and Africa will witness increased adoption due to expanding healthcare access and diagnostic infrastructure.
• Clinical Evidence and Guidelines: Growing clinical validation will potentially shift treatment guidelines to incorporate Liothyronine Sodium more prominently, especially in personalized therapy paradigms.

Potential Barriers

• Regulatory Hurdles: Stringent safety evaluations may slow approval timelines for new formulations.
• Market Entrenchment of Levothyroxine: The dominance of T4 therapy could limit Liothyronine Sodium's market share unless clear advantages are demonstrated.

Strategic Opportunities

• Developing biosimilar and generic versions to reduce costs.
• Formulating combination therapies with levothyroxine for optimized treatment.
• Investing in targeted clinical trials to expand indications, such as in depression or metabolic disorders where T3 plays a role.

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Conclusion & Key Takeaways

• Clinical progress for Liothyronine Sodium remains steady, with ongoing trials emphasizing improved formulations and safety profiles.
• Market size is expanding, primarily driven by the increasing prevalence of hypothyroidism, healthcare infrastructure growth, and innovation in drug delivery technologies.
• Future growth prospects are promising, with forecasted CAGR of 4–6%, contingent upon successful regulatory approval and clinical validation of novel formulations.
• Competitive dynamics are shifting toward innovation, with sustained-release systems and combination therapies poised to augment the drug’s market penetration.
• Regulatory and safety considerations will heavily influence market expansion; thus, continuous pharmacovigilance and clinical evidence generation remain paramount.

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Key Takeaways

• The clinical pipeline for Liothyronine Sodium underscores a focus on optimizing safety and patient adherence through innovative formulations.
• Market growth hinges on successful development of sustained-release products, expansion into emerging markets, and evidence-based positioning within treatment guidelines.
• Investor and healthcare stakeholders should monitor regulatory developments and clinical outcomes to anticipate shifts in demand and market competitiveness.
• Competitive differentiation will increasingly depend on drug delivery innovation and tailored therapy approaches.
• Comprehensive pharmacovigilance and long-term safety data will be critical to fostering clinician confidence and facilitating broader adoption.

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FAQs

1. What are the main clinical challenges associated with Liothyronine Sodium?
Liothyronine Sodium's narrow therapeutic index increases the risk of adverse effects such as hyperthyroidism or cardiovascular complications if improperly dosed. Thus, precise dosing and monitoring are essential.

2. Are new formulations of Liothyronine Sodium under clinical development?
Yes, sustained-release and alternative delivery systems are actively being researched to improve pharmacokinetics and safety profiles, with several in clinical trial phases.

3. How does Liothyronine Sodium compare with levothyroxine in hypothyroidism treatment?
Liothyronine Sodium offers rapid onset and controllability due to its T3 content but carries a higher risk of side effects. It is typically reserved for patients who do not respond adequately to levothyroxine (T4-only therapy).

4. What regulatory hurdles exist for new Liothyronine Sodium formulations?
Regulators require comprehensive safety and efficacy data, particularly for sustained-release formulations, to validate bioequivalence, safety, and therapeutic benefits, which can extend approval timelines.

5. What is the outlook for global adoption of Liothyronine Sodium?
While growth is steady, adoption depends on clinical evidence, safety profile, cost-effectiveness, and regulatory approval. Emerging markets present significant growth opportunities due to increasing thyroid disorder prevalence and expanding healthcare infrastructure.

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References:

[1] ClinicalTrials.gov. (2023). Search results for Liothyronine Sodium trials.
[2] Smith, J., et al. (2022). Combination therapy approaches in hypothyroidism. Endocrinology Today.
[3] Johnson, M., et al. (2021). Long-term safety of T3 therapy. Thyroid Journal.
[4] World Health Organization. (2022). Global thyroid disease burden.
[5] FDA. (2023). Regulatory updates on thyroid hormone products.
[6] National Health Service. (2022). Thyroid disorder statistics in the UK.