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.

Clinical Trial Conditions for Liothyronine Sodium

Condition Name

Condition Name for Liothyronine Sodium
Intervention	Trials
Head and Neck Cancer	2
Healthy	2
ARDS, Human	1
Non-thyroidal Illness Syndrome	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
Indonesia	1
Korea, Republic of	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
Recruiting	2
Terminated	2

Clinical Trial Sponsors for Liothyronine Sodium

Sponsor Name

Sponsor Name for Liothyronine Sodium
Sponsor	Trials
National Cancer Institute (NCI)	4
Ipe, LLC	2
CRDF Global	1

Sponsor Type

Sponsor Type for Liothyronine Sodium
Sponsor	Trials
Other	14
NIH	4
Industry	4

Liothyronine Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Liothyronine Sodium

Liothyronine sodium, a synthetic form of the thyroid hormone triiodothyronine (T3), is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. Here, we will delve into the current clinical trials, market analysis, and future projections for this medication.

Clinical Trials

While there are no specific ongoing clinical trials solely focused on liothyronine sodium mentioned in the recent sources, it is important to note that clinical trials for thyroid hormones often involve comparisons with other thyroid hormone treatments.

Related Clinical Trials Context

For instance, a clinical trial on levothyroxine (another thyroid hormone) in pediatric patients with congenital hypothyroidism provides some context on how thyroid hormone treatments are studied. The trial involves comparing Tirosint®-SOL (a liquid formulation of levothyroxine) with conventional levothyroxine sodium crushed tablets in neonates and infants. This study highlights the importance of formulation and dosing in thyroid hormone therapy, which could have implications for liothyronine sodium as well[1].

Market Analysis

Global Market Size and Growth

The global liothyronine sodium market is expected to see significant growth over the coming years. As of 2023, the market size was substantial, and it is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2031. This growth is driven by increasing demand for thyroid hormone replacement therapies and advancements in healthcare infrastructure[2][3].

Regional Analysis

The market is segmented into major regions including North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region is analyzed for its revenue share, current trends, and future growth prospects. The Asia-Pacific region is expected to be a significant contributor to the market growth due to its large population and improving healthcare systems[2][3].

Application and Product Segmentation

The liothyronine sodium market is segmented based on application and product type. The application segments include various end-use industries such as hospitals, clinics, and pharmacies. The product segmentation involves different forms of liothyronine sodium, such as tablets and other formulations. Understanding these segments helps in identifying the most lucrative areas for investment and growth[2][3].

Market Trends and Drivers

Increasing Prevalence of Hypothyroidism

The rising prevalence of hypothyroidism globally is a key driver for the liothyronine sodium market. As the population ages and awareness about thyroid disorders increases, more people are being diagnosed and treated, leading to higher demand for thyroid hormone replacement therapies.

Technological Advancements

Advancements in pharmaceutical technology, such as improved formulations and delivery systems, are enhancing the efficacy and patient compliance of liothyronine sodium. For example, the development of more stable and bioavailable formulations can improve treatment outcomes.

Regulatory Environment

Regulatory environments play a crucial role in the pharmaceutical market. Ensuring compliance with regulatory standards and addressing any defects or errors, such as the recent issue with the patient information leaflet for liothyronine sodium tablets by Strides Pharma UK Ltd, is essential for maintaining market trust and safety[5].

Challenges and Restraints

Quality Control Issues

Errors in packaging or patient information leaflets, as seen with Strides Pharma UK Ltd, can impact patient trust and compliance. Ensuring the quality of the product and associated information is critical to maintaining market confidence[5].

Competition from Other Thyroid Hormones

The market for thyroid hormones is competitive, with levothyroxine (T4) being a dominant player. Liothyronine sodium (T3) must compete with T4 and combination therapies (T3/T4) for market share.

Future Projections

Market Size and Revenue

The global liothyronine sodium market is projected to grow significantly from 2024 to 2031, with estimated revenue increases in all major regions. The market size is expected to expand due to the increasing demand for effective thyroid hormone replacement therapies[2][3].

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, are expected to contribute substantially to the growth of the liothyronine sodium market. Improving healthcare infrastructure and increasing awareness about thyroid disorders in these regions will drive demand.

Technological Innovations

Future innovations in pharmaceutical technology, such as more advanced formulations and delivery systems, will continue to drive the market forward. These innovations could include sustained-release formulations or more patient-friendly dosing regimens.

Key Takeaways

• Growing Demand: The global liothyronine sodium market is driven by the increasing prevalence of hypothyroidism and advancements in healthcare.
• Regional Growth: The Asia-Pacific region is expected to be a significant contributor to market growth.
• Technological Advancements: Improvements in formulations and delivery systems are enhancing treatment efficacy and patient compliance.
• Regulatory Compliance: Ensuring quality and compliance with regulatory standards is crucial for market success.
• Competition: Liothyronine sodium competes with other thyroid hormones and combination therapies for market share.

FAQs

What is liothyronine sodium used for?

Liothyronine sodium is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones.

What are the key drivers of the liothyronine sodium market?

The key drivers include the increasing prevalence of hypothyroidism, technological advancements in pharmaceuticals, and improving healthcare infrastructure in emerging markets.

What regions are expected to contribute significantly to the market growth?

The Asia-Pacific region is expected to be a significant contributor to the growth of the liothyronine sodium market.

What challenges does the liothyronine sodium market face?

The market faces challenges such as quality control issues, competition from other thyroid hormones, and regulatory compliance.

How is the market segmented?

The market is segmented based on application, product type, and geographical regions.

What is the projected growth rate of the liothyronine sodium market?

The market is projected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2031.

Sources

1. UCSF Clinical Trials: "Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)"[1].
2. Cognitive Market Research: "Liothyronine Sodium Market Report 2024 (Global Edition)"[2].
3. Market Research Intellect: "Liothyronine Sodium Market Size, Share, Trends, Scope And Forecast"[3].
4. ClinicalTrials.gov: "Approved - ClinicalTrials.gov"[4].
5. GOV.UK: "Class 4 Medicines Defect Information: Strides Pharma UK Ltd, Liothyronine Sodium 5 & 20 micrograms Tablets, EL(24)A/58"[5].