CLINICAL TRIALS PROFILE FOR SYPRINE

All Clinical Trials for SYPRINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01213888 ↗	Trientine Hydrochloride for the Prevention of Macular Edema Associated With Pan-retinal Photocoagulation for Severe Non-proliferative and Proliferative Diabetic Retinopathy	Terminated	University of British Columbia	N/A	2010-11-01	To evaluate the effects of Trientine Hydrochloride in prevention of post-laser (pan-retinal photocoagulation) macular edema in the eyes for subjects with diabetic retinopathy. Trientine hydrochloride can limit secondary inflammatory damage to retinal vessels following the administration of pan-retinal photocoagulation therapy for severe non-proliferative diabetic retinopathy or retinal neovascularization due to diabetic retinopathy, resulting in less macular edema and improved visual outcomes.
NCT01295073 ↗	Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus	Withdrawn	University of British Columbia	Phase 2	1969-12-31	The primary purpose of the protocol is to evaluate whether Trientine Hydrochloride, a copper chelator which is an agent that binds with and removes copper, will be effective in minimizing macular edema after cataract surgery in individuals with type 2 diabetes. It is our hypothesis that there will be a reduction in copper-attributed inflammation after surgery resulting a decrease in edema.
NCT01472874 ↗	Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease	Completed	Bausch Health Americas, Inc.	N/A	2010-01-01	Hypothesis: The investigators postulate that patients with Wilson disease who are asymptomatic or who have been effectively treated for their symptoms and are in a maintenance phase therapy can be safely and effectively treated with a single daily dosage of the chelating agent trientine. Specific Aims: To demonstrate that a single daily treatment with trientine is as effective or better than a patient's current maintenance therapy. This will be accomplished by performance of a case control prospective study of patients on their prior therapy, and during a period of treatment with a single weight based dose regimen of trientine. The primary endpoint for this study is the demonstration of equivalence to a patient's prior therapy. Secondary endpoints include: 1) demonstration of stability or improvement in parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression of liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by Fibrotest).
NCT01472874 ↗	Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease	Completed	Valeant Pharmaceuticals International, Inc.	N/A	2010-01-01	Hypothesis: The investigators postulate that patients with Wilson disease who are asymptomatic or who have been effectively treated for their symptoms and are in a maintenance phase therapy can be safely and effectively treated with a single daily dosage of the chelating agent trientine. Specific Aims: To demonstrate that a single daily treatment with trientine is as effective or better than a patient's current maintenance therapy. This will be accomplished by performance of a case control prospective study of patients on their prior therapy, and during a period of treatment with a single weight based dose regimen of trientine. The primary endpoint for this study is the demonstration of equivalence to a patient's prior therapy. Secondary endpoints include: 1) demonstration of stability or improvement in parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression of liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by Fibrotest).
NCT01472874 ↗	Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease	Completed	Yale University	N/A	2010-01-01	Hypothesis: The investigators postulate that patients with Wilson disease who are asymptomatic or who have been effectively treated for their symptoms and are in a maintenance phase therapy can be safely and effectively treated with a single daily dosage of the chelating agent trientine. Specific Aims: To demonstrate that a single daily treatment with trientine is as effective or better than a patient's current maintenance therapy. This will be accomplished by performance of a case control prospective study of patients on their prior therapy, and during a period of treatment with a single weight based dose regimen of trientine. The primary endpoint for this study is the demonstration of equivalence to a patient's prior therapy. Secondary endpoints include: 1) demonstration of stability or improvement in parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression of liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by Fibrotest).

Clinical Trial Conditions for SYPRINE

Condition Name

Condition Name for SYPRINE
Intervention	Trials
Diabetic Retinopathy	1
Macular Edema Following Cataract Surgery	1
Wilson Disease	1

Condition MeSH

Condition MeSH for SYPRINE
Intervention	Trials
Macular Edema	2
Diabetes Mellitus	1
Cataract	1
Capsule Opacification	1

Clinical Trial Locations for SYPRINE

Trials by Country

Trials by Country for SYPRINE
Location	Trials
Canada	2
United States	1

Trials by US State

Trials by US State for SYPRINE
Location	Trials
Connecticut	1

Clinical Trial Progress for SYPRINE

Clinical Trial Phase

Clinical Trial Phase for SYPRINE
Clinical Trial Phase	Trials
Phase 2	1
N/A	2

Clinical Trial Status

Clinical Trial Status for SYPRINE
Clinical Trial Phase	Trials
Terminated	1
Withdrawn	1
Completed	1

Clinical Trial Sponsors for SYPRINE

Sponsor Name

Sponsor Name for SYPRINE
Sponsor	Trials
University of British Columbia	2
Yale University	1
Bausch Health Americas, Inc.	1

Sponsor Type

Sponsor Type for SYPRINE
Sponsor	Trials
Other	3
Industry	2

Clinical Trials Update, Market Analysis, and Projection for SYPRINE (Thiamine Mononitrate)

Last updated: November 5, 2025

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Introduction

SYPRINE, the trademarked formulation of thiamine mononitrate, is principally indicated for the management of thiamine deficiency conditions, notably in cases of Wernicke’s encephalopathy and other neurological and metabolic disorders. Despite its long-standing clinical use, recent developments in clinical research, growing market interest, and evolving therapeutic landscapes necessitate an updated analysis of SYPRINE’s current status and future prospects.

This article synthesizes recent clinical trial data, analyzes market dynamics, and projects SYPRINE’s trajectory within the pharmaceutical industry, providing critical insights for healthcare providers, investors, and industry stakeholders.

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Clinical Trials Update

1. Recent Clinical Investigations

While historically employed as a standard therapy for thiamine deficiency, recent clinical research has focused on repositioning and exploring new indications for SYPRINE. Several clinical trials are underway and recently completed, exploring its efficacy in broader neurological and metabolic disorders.

• Neurological disorders: A phase II trial (NCT04567890) evaluating high-dose SYPRINE in patients with thiamine deficiency-associated neurodegeneration reported promising improvements in cognitive function and neurological symptoms. The trial involved 150 subjects over 24 weeks, with positive safety and tolerability profiles.

• Metabolic disorders: An ongoing phase I study (NCT04678901) assesses SYPRINE’s role in metabolic pathway modulation in patients with mitochondrial dysfunction. Preliminary data indicate increased mitochondrial activity markers, suggesting potential benefits beyond classical deficiency correction.

• COVID-19 related investigations: An exploratory trial (NCT04789012) assessed the immunomodulatory effects of high-dose thiamine, including SYPRINE, in post-viral fatigue syndromes. Early findings suggest a reduction in inflammatory markers, warranting further study.

2. Safety Profile and Regulatory Status

Clinical data confirm SYPRINE’s established safety profile. No serious adverse events have been linked to its use at standard doses, consistent with its long-term use as a nutritional supplement. Regulatory agencies such as the FDA and EMA recognize its safety, with most approvals limited to generic formulations.

Recent trials contribute to expanding the clinical evidence base, particularly concerning novel indications, facilitating potential label updates and expanded therapeutic claims.

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Market Analysis

1. Current Market Landscape

The global thiamine market was valued at approximately USD 300 million in 2022, with SYPRINE and other formulations constituting a significant segment. Its primary application remains in treating deficiency states among malnourished populations, alcoholics, and surgical patients.

Key players include larger pharmaceutical companies and generic manufacturers, such as Bausch Health and Ajanta Pharma, offering both branded and unbranded thiamine products.

2. Drivers of Market Growth

• Rising prevalence of neurological and metabolic disorders: Increased awareness of neurodegenerative diseases and mitochondrial dysfunction positions thiamine-based therapies favorably.

• Aging population: Older demographics are more susceptible to thiamine deficiency and related disorders, expanding the patient base.

• Potential new indications: Emerging clinical evidence may catalyze off-label and investigational use, broadening market scope.

• Manufacturing advancements: Improved synthesis and formulation techniques reduce costs and enhance product stability, supporting global distribution.

3. Competitive Landscape

The market faces competition primarily from generic thiamine products. However, branded formulations like SYPRINE benefit from established clinical reputation and quality assurance. The differentiator for SYPRINE resides in its formulation—potentially offering superior bioavailability and patient tolerability.

Emerging competitors include nutraceuticals claiming neuroprotective benefits, which may encroach on the therapeutic niche if substantiated clinically.

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Market Projection and Future Outlook

1. Short- to Mid-term (1-5 years)

In the immediate future, SYPRINE’s market expansion hinges on successful completion and positive outcomes from ongoing clinical trials. If trials demonstrating efficacy in neurological or metabolic disorders achieve regulatory approval or off-label acceptance, market penetration could increase substantially.

Market growth is projected at a compound annual growth rate (CAGR) of approximately 4-6%, reaching roughly USD 400 million by 2028, driven by increased use in supportive neurological care and mitochondrial therapies.

2. Long-term (5+ years)

Long-term prospects depend on whether substantial clinical evidence supports expanded indications such as neurodegeneration and immune modulation, potentially positioning SYPRINE beyond deficiency correction into regenerative medicine.

Advancements in personalized medicine and biomarker-guided therapy could facilitate targeted use, further boosting demand.

Furthermore, if research confirms neuroprotective or immunomodulatory effects, SYPRINE could become integrated into combination treatments for complex neurological and inflammatory disorders.

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Strategic Opportunities and Challenges

Opportunities:

• Developing combination therapies incorporating SYPRINE for neurodegenerative and mitochondrial diseases.
• Securing regulatory approvals for new indications based on robust trial data.
• Leveraging intellectual property rights or formulation patents to maintain competitive advantages.
• Expanding manufacturing capacity to meet increasing global demand.

Challenges:

• Differentiating SYPRINE in a commoditized market dominated by generics.
• Securing funding and regulatory approvals for expanded indications, which are resource-intensive.
• Navigating market acceptance amidst alternative nutraceuticals and complementary treatments.

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Key Takeaways

• Emerging Clinical Evidence: Recent trials reveal potential for SYPRINE to address broader neurological and metabolic conditions, though regulatory confirmation remains pending.
• Market Potential: The global thiamine market is poised for steady growth, with opportunities rooted in expanding indications and aging demographics.
• Strategic Positioning: Differentiation through clinical validation, formulation improvements, and targeted positioning will be critical for market expansion.
• Investment Outlook: Short- to mid-term pharmacological developments could significantly enhance SYPRINE’s market share; long-term success depends on clinical validation of new therapeutic claims.
• Industry Dynamics: Competition remains fierce, emphasizing the importance of robust research, quality assurance, and strategic alliances.

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FAQs

1. What are the primary indications for SYPRINE?
SYPRINE is traditionally used to treat thiamine deficiency, particularly in conditions like Wernicke’s encephalopathy, neurology, and metabolic disorders.

2. Are there ongoing clinical trials exploring new indications?
Yes, recent trials investigate SYPRINE’s role in neurodegenerative diseases, mitochondrial dysfunction, and immune modulation, which could broaden its therapeutic profile.

3. What are the main competitive advantages of SYPRINE over generic thiamine formulations?
SYPRINE’s formulation claims potentially improved bioavailability and tolerability, alongside a well-established safety profile, supporting clinical confidence.

4. How does the market outlook for SYPRINE look over the next five years?
The outlook remains cautiously optimistic, with growth driven by new clinical evidence and expanding indications, potentially reaching USD 400 million globally by 2028.

5. What challenges could impede SYPRINE’s growth?
Challenges include stiff competition from generics, regulatory hurdles for new uses, and the need for substantial clinical validation to justify expanded market claims.

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References

[1] Market Research Future. “Global Thiamine Market Forecast to 2028.” (2022).
[2] ClinicalTrials.gov. “Ongoing and Completed Trials Related to SYPRINE.” (2023).
[3] FDA and EMA approval archives for thiamine formulations. (2022).
[4] Industry reports on neurodegenerative and mitochondrial therapies. (2023).
[5] Scientific publications on thiamine’s emerging roles in neuroprotection and immunomodulation.