CLINICAL TRIALS PROFILE FOR TIROSINT

All Clinical Trials for tirosint

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04747275 ↗	Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients	Recruiting	Children's Mercy Hospital Kansas City	Phase 4	2021-01-18	Children with levothyroxine (T21) have developmental delay and other functional gastrointestinal (GI) issues that may negatively affect L-T4 tolerability and absorption. For an age group unable to swallow tablets whole by mouth, tablets must be crushed and suspended in water, breast milk or formula for administration in order to treat children with hypothyroidism. For this age group, ease of administration may have a significant impact on compliance and ability to remain euthyroid. We propose that Tirosint-SOL® will be more favorably received due to ease of administration, improved tolerability and palatability, therefore leading to improved adherence when compared to L-T4 tablets.
NCT03094416 ↗	Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors	Completed	IBSA Institut Biochimique SA	Phase 4	2018-07-30	This is an open-label therapeutic efficacy study of Tirosint (levothyroxine sodium) capsules in thyroidectomized patients taking proton pump inhibitors and levothyroxine, evaluating changes in serum levels of TSH upon switch to Tirosint with respect to baseline.
NCT02567877 ↗	Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?	Recruiting	Charite University, Berlin, Germany		2016-11-01	Patients taking thyroid hormone replacement after thyroid removal surgery often report feeling differently than they did prior to taking thyroid hormone. The symptoms can include fatigue, worsening mood or subjective "brain fog" where the patient feels like their thinking is just not as sharp as it was previously. Multiple studies have found that patients taking thyroid hormone replacement have a diminished quality of life compared to matched controls. Previous studies have suggested that the type of deiodinase (DIO) polymorphism a patient has, which is responsible for converting the thyroid hormone T4 into the more biologically active T3, may contribute to their overall cognition and sense of well-being. The Investigators aim to determine if the type of deiodinase polymorphism a patient has contributes to the patient's cognition and overall sense of well-being after surgery and thyroid hormone replacement. Objective: Determine if patients with the deiodinase type 2 CC polymorphism have objective differences in working memory (N-back test is primary endpoint), cognitive function and sense of well-being after thyroidectomy when placed on standard thyroid hormone replacement therapy. Hypotheses: (1) Patients with the deiodinase type 2 CC polymorphism will have worse working memory (N-back test is primary endpoint), cognitive function and sense of well-being on standard thyroid hormone replacement therapy after thyroidectomy compared with before thyroidectomy. (2) Patients with the deiodinase type 2 TT or TC polymorphism will have no differences in working memory, cognitive function or sense of well-being on standard thyroid hormone replacement before and after thyroidectomy.
NCT02567877 ↗	Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?	Recruiting	University of Colorado, Denver		2016-11-01	Patients taking thyroid hormone replacement after thyroid removal surgery often report feeling differently than they did prior to taking thyroid hormone. The symptoms can include fatigue, worsening mood or subjective "brain fog" where the patient feels like their thinking is just not as sharp as it was previously. Multiple studies have found that patients taking thyroid hormone replacement have a diminished quality of life compared to matched controls. Previous studies have suggested that the type of deiodinase (DIO) polymorphism a patient has, which is responsible for converting the thyroid hormone T4 into the more biologically active T3, may contribute to their overall cognition and sense of well-being. The Investigators aim to determine if the type of deiodinase polymorphism a patient has contributes to the patient's cognition and overall sense of well-being after surgery and thyroid hormone replacement. Objective: Determine if patients with the deiodinase type 2 CC polymorphism have objective differences in working memory (N-back test is primary endpoint), cognitive function and sense of well-being after thyroidectomy when placed on standard thyroid hormone replacement therapy. Hypotheses: (1) Patients with the deiodinase type 2 CC polymorphism will have worse working memory (N-back test is primary endpoint), cognitive function and sense of well-being on standard thyroid hormone replacement therapy after thyroidectomy compared with before thyroidectomy. (2) Patients with the deiodinase type 2 TT or TC polymorphism will have no differences in working memory, cognitive function or sense of well-being on standard thyroid hormone replacement before and after thyroidectomy.
NCT02917863 ↗	Randomized Crossover Trial for the Evaluation of the Possible Effects in the Intestine of Two Different Pharmaceutical Forms of L - Thyroxine in Patients With Primary Acquired Hypothyroidism	Unknown status	Meyer Children's Hospital	Phase 4	2016-05-01	Thyroid disorders, in particular hypothyroidism, are associated with gastrointestinal impairment, such as celiac disease. A study reported an increased prevalence of celiac disease in a large cohort of children affected by congenital hypothyroidism, underlying the relationship between these two conditions. The hypothesis of our study is that the onset of celiac disorder may be related to the gut concentration of thyroid hormone (TH) in hypothyroidism patients treated with replacement therapy. In fact, TH replacement therapy showed a low bioavailability with a consequent high gut concentration. Two different pharmaceutical formulations (liquid and solid, per os) are available. The liquid one has a better absorption profile and bioavailability than the solid; therefore, it is associated with a low TH intestinal concentration. According to our hypothesis, the solid TH formulation could increase the microbial diversity in the gut instead of the liquid form, due to the high local TH concentration. Based on these findings, the purpose of this study is to evaluate the effect of two different pharmaceutical formulations of TH on the gut in terms of modification of gut microbiota, inflammatory parameters and gut absorption.
NCT01832753 ↗	Treatment Trial of Subclinical Hypothyroidism in Down Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	2013-01-01	The purpose of this research study is to learn about the effects of treating subclinical hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will improve cardiometabolic health and quality of life.
NCT01832753 ↗	Treatment Trial of Subclinical Hypothyroidism in Down Syndrome	Completed	Children's Hospital of Philadelphia	N/A	2013-01-01	The purpose of this research study is to learn about the effects of treating subclinical hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will improve cardiometabolic health and quality of life.

Clinical Trial Conditions for tirosint

Condition Name

Condition Name for tirosint
Intervention	Trials
Hypothyroidism	4
Hypothyroidism;Postablative	1
Postsurgical Hypothyroidism	1
Subclinical Hypothyroidism	1

Condition MeSH

Condition MeSH for tirosint
Intervention	Trials
Hypothyroidism	7
Down Syndrome	2
Congenital Hypothyroidism	1
Trisomy	1

Clinical Trial Locations for tirosint

Trials by Country

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−

Trials by Country for tirosint
Location	Trials
United States	14
Italy	1

Trials by US State

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−

Trials by US State for tirosint
Location	Trials
California	2
District of Columbia	2
Texas	1
Missouri	1
Washington	1

Clinical Trial Progress for tirosint

Clinical Trial Phase

Clinical Trial Phase for tirosint
Clinical Trial Phase	Trials
Phase 4	5
N/A	1

Clinical Trial Status

Clinical Trial Status for tirosint
Clinical Trial Phase	Trials
Recruiting	4
Completed	2
Unknown status	1

Clinical Trial Sponsors for tirosint

Sponsor Name

Sponsor Name for tirosint
Sponsor	Trials
IBSA Institut Biochimique SA	2
Charite University, Berlin, Germany	1
University of Colorado, Denver	1

Sponsor Type

Sponsor Type for tirosint
Sponsor	Trials
Other	6
Industry	3
NIH	1

Tirosint: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Tirosint

Tirosint, a synthetic form of the thyroid hormone thyroxine (levothyroxine sodium), is a crucial medication for treating hypothyroidism and managing certain types of thyroid cancer. It is available in both capsule and liquid oral solution forms, each with its own set of advantages and clinical applications.

Clinical Trials and Studies

Tirosint-SOL Clinical Trials

The FDA-approved Tirosint-SOL (levothyroxine sodium oral solution) has undergone significant clinical trials to establish its efficacy and safety. Studies have shown that Tirosint-SOL can be taken just 15 minutes before breakfast without any clinically significant differences in levothyroxine pharmacokinetics compared to taking it 30 minutes to 1 hour before a high-fat, high-calorie meal[1].

Additionally, clinical trials have demonstrated that Tirosint-SOL does not interact with proton pump inhibitors (PPIs), such as omeprazole, regardless of the timing of PPI administration. This makes it a more convenient option for patients who may be taking multiple medications[1].

Pediatric Clinical Trials

An ongoing multi-center, prospective clinical study at UCSF is evaluating the use of Tirosint-SOL versus conventional levothyroxine sodium tablets in neonates and infants diagnosed with congenital hypothyroidism. This study aims to compare the efficacy and safety of these two formulations over a 12-month period, with dose adjustments allowed based on laboratory parameters and clinical response[4].

Historical Context and Previous Studies

The development of Tirosint-SOL was preceded by clinical trials in Italy, which showed that the liquid formulation could overcome some of the limitations associated with levothyroxine tablets, such as interference from gastritis, coeliac disease, lactose intolerance, and certain foods or medications. These trials were instrumental in gaining FDA approval for the US market[2].

Market Analysis

Global Demand and Market Size

The global levothyroxine sodium API market, which includes Tirosint, is experiencing significant growth. As of 2023, the market was valued at US$ 31 million and is projected to reach US$ 42 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.5% during the forecast period of 2024-2030[5].

Driving Factors

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

• Rising Prevalence of Thyroid Disorders: The increasing incidence of thyroid-related conditions, particularly hypothyroidism, is a major driver.
• Aging Population: The growing aging population contributes to the higher demand for thyroid medications.
• Regulatory Approvals: Regulatory approvals for new formulations, including generic variants, expand market access and competition.
• Pharmaceutical Sector Expansion: The overall growth of the pharmaceutical industry, driven by research and development, supports the production and demand for levothyroxine-based medications[5].

Market Dynamics

The market for levothyroxine sodium API is characterized by the presence of several key players, including Novartis, Azico Biophore India, Excella GmbH & Co., and Peptido GmbH. The availability of generic formulations, which enter the market when patents on branded formulations expire, increases competition and patient access to these medications[5].

Projections and Future Outlook

Market Growth Projections

Given the current trends, the levothyroxine sodium API market is expected to continue growing, driven by the increasing demand for thyroid medications and the expansion of pharmaceutical production capacities, especially in emerging markets.

Clinical and Therapeutic Advancements

The ongoing clinical trials, such as the one at UCSF, will provide further insights into the efficacy and safety of Tirosint-SOL in pediatric populations. These studies are crucial for expanding the therapeutic applications of Tirosint and improving patient outcomes.

Patient Benefits and Convenience

The updated labeling for Tirosint-SOL, allowing it to be taken just 15 minutes before breakfast and without interaction with PPIs, enhances patient convenience and compliance. This simplicity and lack of drug interactions make Tirosint-SOL an attractive option for both patients and healthcare practitioners[1].

Key Takeaways

• Clinical Trials: Tirosint-SOL has been shown to be effective and safe, with no significant interactions with PPIs and flexible dosing timing.
• Market Growth: The global levothyroxine sodium API market is projected to grow from US$ 31 million in 2023 to US$ 42 million by 2030.
• Driving Factors: Rising prevalence of thyroid disorders, aging population, and regulatory approvals are key drivers of market growth.
• Patient Benefits: Tirosint-SOL offers convenience and simplicity in dosing, making it a preferred option for hypothyroid patients.

FAQs

Q: What is Tirosint-SOL used for?

A: Tirosint-SOL is used as a replacement therapy for primary, secondary, and tertiary hypothyroidism, and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer[1].

Q: How has the dosing of Tirosint-SOL been updated?

A: The dosing of Tirosint-SOL has been updated to allow it to be taken on an empty stomach 15 minutes before breakfast, rather than the previous recommendation of 30 minutes to 1 hour before breakfast[1].

Q: Does Tirosint-SOL interact with proton pump inhibitors (PPIs)?

A: No, clinical studies have shown that Tirosint-SOL does not interact with PPIs, such as omeprazole, regardless of the timing of PPI administration[1].

Q: What is the current market size and projected growth of the levothyroxine sodium API market?

A: The global levothyroxine sodium API market was valued at US$ 31 million in 2023 and is projected to reach US$ 42 million by 2030, with a CAGR of 4.5% during the forecast period[5].

Q: Who are the key players in the levothyroxine sodium API market?

A: Key players include Novartis, Azico Biophore India, Excella GmbH & Co., and Peptido GmbH[5].

Sources

1. EMPR: Tirosint-SOL Label Changes: PPI Interaction Removed, Timing of Administration Updated.
2. Biospace: The FDA Has Approved Tirosint-SOL, Levothyroxine In Liquid Solution For The American Market.
3. Health Canada: Regulatory Decision Summary for Tirosint.
4. UCSF Clinical Trials: Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients.
5. Valuates Reports: Global Levothyroxine Sodium API Market Research Report 2024.