CLINICAL TRIALS PROFILE FOR LEVOTHYROXINE SODIUM

505(b)(2) Clinical Trials for Levothyroxine Sodium

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	NCT04037748 ↗	Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form	Completed	Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany	Phase 1	2019-06-25	The study was to verify if the test formulation of Levothyroxine sodium presents an equivalent rate and extension of absorption to the comparator formulation when administered with the same dosage and under fasting conditions and after baseline correction concentrations.
New Formulation	NCT04037748 ↗	Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form	Completed	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	Phase 1	2019-06-25	The study was to verify if the test formulation of Levothyroxine sodium presents an equivalent rate and extension of absorption to the comparator formulation when administered with the same dosage and under fasting conditions and after baseline correction concentrations.

All Clinical Trials for Levothyroxine Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00647855 ↗	Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μg	Completed	Mylan Pharmaceuticals	Phase 1	2003-05-01	The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 μg tablets to Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy volunteers under fasting conditions. Single-dose pharmacokinetic parameters for baseline corrected total L-thyroxine and non-baseline corrected total L-triiodothyronine were calculated using noncompartmental techniques.
NCT00648557 ↗	Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg	Completed	Mylan Pharmaceuticals	Phase 1	2003-01-01	The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label, randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D. Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that 90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200 μg) dose under fasting conditions

Clinical Trial Conditions for Levothyroxine Sodium

Condition Name

Condition Name for Levothyroxine Sodium
Intervention	Trials
Healthy	9
Hypothyroidism	5
Kidney Diseases, Chronic	1

Condition MeSH

Condition MeSH for Levothyroxine Sodium
Intervention	Trials
Hypothyroidism	8
Thyroid Diseases	3
Pathologic Processes	1

Clinical Trial Locations for Levothyroxine Sodium

Trials by Country

Trials by Country for Levothyroxine Sodium
Location	Trials
United States	19
China	4
Brazil	2
Mexico	1
Belgium	1

Trials by US State

Trials by US State for Levothyroxine Sodium
Location	Trials
California	4
North Dakota	4
District of Columbia	2
Maryland	2
Pennsylvania	1

Clinical Trial Progress for Levothyroxine Sodium

Clinical Trial Phase

Clinical Trial Phase for Levothyroxine Sodium
Clinical Trial Phase	Trials
Phase 4	8
Phase 2/Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Levothyroxine Sodium
Clinical Trial Phase	Trials
Completed	12
Recruiting	6
Not yet recruiting	3

Clinical Trial Sponsors for Levothyroxine Sodium

Sponsor Name

Sponsor Name for Levothyroxine Sodium
Sponsor	Trials
Mylan Pharmaceuticals	4
IBSA Institut Biochimique SA	2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2

Sponsor Type

Sponsor Type for Levothyroxine Sodium
Sponsor	Trials
Other	26
Industry	15
NIH	3

Levothyroxine Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Levothyroxine Sodium

Levothyroxine sodium is a synthetic form of the thyroid hormone thyroxine (T4), widely used to treat hypothyroidism, a condition characterized by an underactive thyroid gland. This medication is crucial for restoring normal thyroid hormone levels and alleviating associated symptoms.

Clinical Trials Update

Xeris Biopharma's Phase 2 Clinical Trial

A significant recent development in the clinical trials of levothyroxine sodium is the Phase 2 study conducted by Xeris Biopharma. This study focused on the company's investigational XeriSol™-formulated once-weekly subcutaneous (SC) levothyroxine (XP-8121)[1].

• Key Findings:

  • The study demonstrated that the XeriSol™ formulation enabled predictable bioavailability and sustained levels of levothyroxine.
  • Participants using the once-weekly SC levothyroxine required 45% less drug than their daily oral dose on a weekly basis to normalize TSH and T4 levels.
  • The study confirmed a 4X target dose conversion factor when switching from once-daily oral administration to once-weekly SC injections, consistent with previous Phase 1 findings.
  • Participants reported higher treatment satisfaction with the SC route, with 72% preferring it over oral administration.
  • The study highlighted the challenges of achieving and maintaining normal TSH levels with daily oral levothyroxine therapy.

• Study Design:

  • The Phase 2 study was a non-randomized, open-label, single-arm, self-controlled study involving 46 patients with hypothyroidism.
  • The study included screening, titration (2 to 8 weeks), and maintenance (4 weeks) periods.

Pediatric Clinical Trial

Another notable clinical trial is the multi-center, prospective, parallel-group, open-label, randomized study comparing Tirosint®-SOL and conventional levothyroxine sodium tablet formulations in neonates and infants diagnosed with congenital hypothyroidism (CH)[4].

• Study Design:
  • The study involves 126 subjects randomized in a 2:1 ratio to either Tirosint®-SOL or conventional therapy with levothyroxine sodium crushed tablets.
  • Subjects will be treated and followed for 12 months, with multiple study visits including in-clinic and telemedicine visits.

Market Analysis

Current Market Size and Growth

The global levothyroxine sodium market has been growing steadily due to several factors:

• Market Size:

  • In 2023, the global levothyroxine sodium market was valued at approximately $3.73 billion[3].
  • Another report valued the market at around $3,671 million in 2022[5].

• Growth Projections:

  • The market is expected to grow to $3.90 billion in 2024 and reach $4.65 billion by 2028, with a compound annual growth rate (CAGR) of 4.5%[3].
  • Alternatively, the market is projected to grow to around $4,598 million by 2030, with a CAGR of approximately 3.27% between 2023 and 2030[5].

Market Drivers

Several factors are driving the growth of the levothyroxine sodium market:

• Increasing Prevalence of Hypothyroidism:

  • The rising incidence of hypothyroidism worldwide, particularly among the elderly, is a significant driver[2][3].

• Advancements in Diagnostic Tools:

  • Improved diagnostic tools and growing awareness of thyroid health are contributing to the increased demand for levothyroxine-based medications[2].

• Generic Formulations and Expanded Health Insurance:

  • The introduction of generic levothyroxine sodium formulations and expanded health insurance coverage for prescription medications have made the treatment more accessible and cost-effective[3].

• Focus on Sustainable Healthcare Practices:

  • The increasing focus on sustainable healthcare practices, quality assurance standards, and patient-centered care models is also influencing market growth[3].

Regional and Segment Analysis

• Regional Segmentation:

  • The market is segmented into regions such as North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. Emerging markets are particularly significant due to their increasing pharmaceutical production capacities and local demand[2][5].

• Segment by Type and Application:

  • The market is analyzed based on different types (e.g., powder and tablets) and applications, providing a thorough perspective of the entire levothyroxine sodium market[5].

Market Projections

Future Growth and Trends

The levothyroxine sodium market is expected to see steady growth in the coming years driven by several trends and factors:

• Rising Awareness and Diagnostic Advancements:

  • Growing awareness of thyroid health and advancements in diagnostic tools will continue to drive the demand for levothyroxine sodium[2].

• New Product Introductions:

  • New product formulations, such as the once-weekly subcutaneous levothyroxine by Xeris Biopharma, are expected to enhance treatment options and patient satisfaction[1].

• Sustainable Healthcare Practices:

  • The focus on sustainable healthcare practices, including the production, distribution, and disposal of levothyroxine sodium products, will influence market growth[3].

• Telemedicine and E-Pharmacy:

  • The integration of telemedicine and e-pharmacy services will make levothyroxine sodium more accessible, especially in regions with limited healthcare infrastructure[3].

Key Takeaways

• Clinical Trials: Recent clinical trials, such as Xeris Biopharma's Phase 2 study, are advancing the delivery methods of levothyroxine sodium, offering more convenient and effective treatment options.
• Market Growth: The global levothyroxine sodium market is projected to grow significantly, driven by increasing prevalence of hypothyroidism, advancements in diagnostic tools, and expanding healthcare coverage.
• Regional Focus: Emerging markets are crucial for the growth of the levothyroxine sodium market due to their increasing pharmaceutical production capacities and local demand.
• Future Trends: New product formulations, sustainable healthcare practices, and the integration of telemedicine and e-pharmacy services will shape the future of the levothyroxine sodium market.

FAQs

What is the current market size of the levothyroxine sodium market?

The global levothyroxine sodium market was valued at approximately $3.73 billion in 2023[3].

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

The market is expected to grow at a compound annual growth rate (CAGR) of 4.5% from 2023 to 2028[3].

What are the key drivers of the levothyroxine sodium market?

Key drivers include the increasing prevalence of hypothyroidism, advancements in diagnostic tools, introduction of generic formulations, and expanded health insurance coverage[2][3].

What new developments are there in the clinical trials of levothyroxine sodium?

Recent clinical trials include Xeris Biopharma's Phase 2 study on once-weekly subcutaneous levothyroxine and a pediatric study comparing Tirosint®-SOL and conventional levothyroxine sodium tablet formulations[1][4].

How is the regional segmentation of the levothyroxine sodium market?

The market is segmented into regions such as North America, Latin America, Europe, Asia Pacific, and Middle East & Africa, with emerging markets playing a significant role[2][5].

Sources

1. Xeris Biopharma Announces Positive Topline Phase 2 Clinical Data of Its Investigational XeriSol™-Formulated Once-Weekly Subcutaneous (SC) Levothyroxine (XP-8121). Xeris Pharma.
2. Global Levothyroxine Sodium API Market Research Report 2024. Valuates.
3. Levothyroxine Sodium Global Market Report 2024. The Business Research Company.
4. Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients with Congenital Hypothyroidism. ClinicalTrials.gov.
5. Levothyroxine sodium Market Size & Share | Forecast [Latest]. Facts Factors.

Last updated: 2025-01-01