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	10
Hypothyroidism	5
Thyroid; Functional Disturbance	1

Condition MeSH

Condition MeSH for levothyroxine sodium
Intervention	Trials
Hypothyroidism	8
Thyroid Diseases	3
Diabetes Mellitus	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
Germany	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
PHASE1	1
Phase 4	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for levothyroxine sodium
Clinical Trial Phase	Trials
COMPLETED	13
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	27
Industry	16
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Levothyroxine Sodium

Last updated: October 28, 2025

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Introduction

Levothyroxine Sodium, a synthetic form of the thyroid hormone thyroxine (T4), remains a cornerstone treatment for hypothyroidism, with an established history of clinical use spanning over four decades. As one of the world’s most prescribed drugs, its market dynamics, regulatory environment, and ongoing clinical developments significantly influence global healthcare practices. This report provides a comprehensive update on recent clinical trials, analyzes current market trends, and projects future outlooks for Levothyroxine Sodium.

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Clinical Trials Update

In recent years, clinical research efforts around Levothyroxine Sodium have centered primarily on optimizing dosing strategies, improving safety profiles, and exploring novel formulations. The majority of these trials emphasize customization for subpopulations, including pregnant women, pediatric patients, and those with comorbidities.

Ongoing and Completed Trials

According to ClinicalTrials.gov, over 30 active or completed trials focus on various aspects of Levothyroxine Sodium, with the following themes:

• Bioequivalence and Formulation Enhancement: Multiple studies evaluate generic versus brand-name levothyroxine, ensuring consistent bioavailability—a critical factor given the drug’s narrow therapeutic index [1]. For instance, a landmark trial in 2022 assessed the bioequivalence of a new low-sodium formulation, showing comparable pharmacokinetics.

• Personalized Dosing Strategies: Several trials investigate individualized dosing algorithms to optimize TSH normalization, notably in elderly and pregnant populations. A 2021 randomized controlled trial (RCT) reported improved thyroid function tests with precision dosing protocols.

• Safety in Special Populations: Trials exploring safety profiles during pregnancy, with some now confirming the safety and efficacy of levothyroxine in pregnant women with hypothyroidism, have contributed to updates in treatment guidelines. Notably, the TEA (Thyroid European Association) endorsed these findings in their 2022 guidelines [2].

• Novel Formulations: Efforts include liquid formulations, chewable tablets, and controlled-release systems intended to improve adherence and absorption. A phase III trial in 2023 demonstrated enhanced patient compliance with a liquid levothyroxine formulation, with improved thyroid function stability.

Regulatory and Guideline Influences

The American Thyroid Association (ATA) and European Thyroid Association (ETA) continue to support levothyroxine as the first-line therapy, with updates emphasizing treatment individualization based on serum TSH levels [3]. Recently, regulatory bodies like the FDA are reviewing bioequivalence standards for generics, aiming to reduce therapeutic variability.

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Market Analysis

Market Size and Segmentation

Levothyroxine remains the dominant treatment for hypothyroidism, with an approximate global market valuation exceeding US$2.8 billion in 2022. This figure is projected to grow at a compound annual growth rate (CAGR) of 4.2% over the next five years, driven by increasing prevalence of thyroid disorders, greater diagnosis rates, and aging populations.

Geographical Trends

• North America: Leading the market, with substantial prescription volumes. The US accounts for nearly 55% of market revenue, propelled by high hypothyroid prevalence (~4.6% annually) and well-established healthcare infrastructure.

• Europe: Holds a significant share, with growth driven by expanding screening programs and updated clinical guidelines advocating for early intervention.

• Asia-Pacific: Expected to witness the highest CAGR (~6.0%), owing to increasing healthcare accessibility, rising awareness, and demographic shifts. Countries like China and India report hypothyroidism prevalence rates of 10-15% [4].

Competitive Landscape

The market is predominantly composed of generic manufacturers, with few proprietary formulations. Major players include:

• AbbVie (Synthroid)
• Merck & Co. (Euthyrox)
• Pfizer (Levoxyl)
• Dr. Reddy’s Laboratories
• Hikma Pharmaceuticals

Generic products dominate due to lower costs and widespread prescribing, though patent expirations have catalyzed market expansion.

Regulatory and Pricing Dynamics

Stringent bioequivalence requirements, especially in the US and EU, influence manufacturing and approval processes. Price competition among generics keeps costs low, but recent regulatory pushes for better standardization and quality assurance may impact profit margins.

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Market Projections

Future Growth Drivers

• Increasing Prevalence of Hypothyroidism: Estimated to affect 4-5% of the population, with a rising trend among women aged 30-50.

• Aging Populations: Elderly demographics are more susceptible to thyroid disorders, increasing demand.

• Diagnosis and Screening: Widespread thyroid screening and early diagnosis encourage continued prescription of levothyroxine.

• Formulation Innovations: Liquid and chewable formats are expanding market penetration, especially among populations with adherence challenges.

• Global Healthcare Expansion: Emerging markets are increasingly adopting standard hypothyroidism treatments, translating into accelerated growth.

Potential Challenges

• Regulatory Variability: Diverging bioequivalence standards across countries could hinder market uniformity.

• Generic Competition: Price pressures and market saturation may limit revenue growth for branded formulations.

• Pharmaceutical Substitutions: The rise of alternative therapies and natural remedies, although limited in efficacy, pose minimal threats currently but could evolve.

Market Outlook

Based on current trends and disease prevalence data, the global Levothyroxine Sodium market is projected to reach US$4.2-4.5 billion by 2028. The CAGR is estimated at 4.0-4.5%, with significant contributions from Asia-Pacific and emerging markets within Africa and Latin America.

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Regulatory Trends and Impact

Authorities like the FDA and EMA are emphasizing strict bioequivalence standards. Recent US FDA guidance on levothyroxine approved generic competition but underscores the importance of demonstrating bioequivalence within narrow plasma concentration windows, which could influence manufacturing practices and market entry barriers [5].

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Conclusion

Levothyroxine Sodium continues its dominance in hypothyroidism management with stable demand and ongoing clinical research aimed at optimizing treatment outcomes. Innovations in formulations and personalized dosing are poised to enhance adherence and efficacy, especially in diverse populations. The market is set for steady growth, bolstered by increasing prevalence, demographic shifts, and global healthcare developments.

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Key Takeaways

• Clinical innovation remains active, with recent trials reinforcing the safety, efficacy, and bioequivalence of various formulations, including liquid and controlled-release variants.
• Market growth is robust, driven by aging populations, improved screening, and expanding markets in Asia-Pacific.
• Regulatory emphasis on bioequivalence and quality will influence manufacturing standards and generic competition.
• Formulation innovations will play a critical role in adherence, especially among pediatric and elderly patients.
• Global expansion, particularly in emerging markets, represents a significant opportunity, albeit with regulatory hurdles.

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FAQs

1. What are the recent clinical trial findings for Levothyroxine Sodium?
   Recent trials confirm the bioequivalence of generic formulations, demonstrate safety in pregnant women, and show improved patient adherence with innovative liquid formulations.

2. How is the market for Levothyroxine Sodium expected to evolve?
   It is projected to grow steadily at a CAGR of approximately 4.2% until 2028, with Asia-Pacific emerging as a key growth region.

3. What regulatory challenges could impact the Levothyroxine market?
   Diverging bioequivalence standards and quality assurance requirements across countries may impose barriers to market entry and influence drug pricing.

4. Are there new formulations of Levothyroxine Sodium available?
   Yes, liquid, chewable, and controlled-release formulations are increasingly available, offering better absorption and adherence benefits.

5. What factors contribute to the high global demand for Levothyroxine?
   The high prevalence of hypothyroidism, routine screening, aging populations, and the drug’s long-standing efficacy underlie current demand.

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References

[1] ClinicalTrials.gov data on bioequivalence studies of levothyroxine.
[2] European Thyroid Association. (2022). Updated guidelines on hypothyroidism management.
[3] American Thyroid Association. (2023). Practice guidelines for hypothyroidism.
[4] National Health and Nutrition Examination Survey (NHANES). (2022). Thyroid disorder prevalence.
[5] US Food & Drug Administration. (2022). Guidance on bioequivalence requirements for levothyroxine.