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.
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).
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.

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
Capsule Opacification	1
Retinal Diseases	1
Hepatolenticular Degeneration	1

Clinical Trial Locations for SYPRINE

Trials by Country

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−

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
Withdrawn	1
Completed	1
Terminated	1

Clinical Trial Sponsors for SYPRINE

Sponsor Name

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

Sponsor Type

Sponsor Type for SYPRINE
Sponsor	Trials
Other	3
Industry	2

Syprine (Trientine Hydrochloride): Clinical Trials, Market Analysis, and Projections

Introduction to Syprine

Syprine, also known as trientine hydrochloride, is a chelating agent used primarily in the treatment of Wilson disease, a rare genetic disorder characterized by excessive copper accumulation in the body. Here, we will delve into the clinical trials, market analysis, and future projections for Syprine.

Mechanism of Action

Trientine hydrochloride works by binding to excess copper in the body, facilitating its excretion through the urine. This mechanism is crucial for managing Wilson disease, as it helps reduce the toxic effects of copper accumulation on the liver, brain, and other organs[1].

Clinical Trials and Efficacy

Several clinical trials have evaluated the efficacy and safety of Syprine compared to other chelating agents, particularly penicillamine.

Comparative Studies with Penicillamine

In trials where patients were switched from penicillamine to Syprine, the efficacy of Syprine was assessed through the measurement of copper excretion rates. Although Syprine appeared less potent than penicillamine on a molar basis, it was found to be efficacious in reducing copper levels in patients with Wilson disease. The studies used radioactively labeled copper to understand the differences in cupriuretic effects between the two medications, highlighting the selectivity of Syprine for various copper pools in the body[1][4].

Stability and Safety

A randomized, open-label, non-inferiority phase 3 trial compared the stability and safety of Syprine with penicillamine in patients with stable Wilson disease. The trial found that patients switched to Syprine maintained clinical stability, with no significant differences in non-caeruloplasmin-bound copper (NCC) levels, 24-hour urinary copper excretion, and liver function tests. The study also confirmed that Syprine did not cause any notable changes in clinical assessments at 24 and 48 weeks[4].

Market Analysis

Current Market Position

Syprine is a niche product catering to a specific patient population with Wilson disease. Given its specialized use, the market for Syprine is relatively small compared to broader therapeutic areas.

Competitive Landscape

The market for Wilson disease treatments is limited, with few alternatives available. However, the competition from generic drugs and biosimilars in other therapeutic areas highlights the broader challenges faced by the life sciences industry. The patent cliff, where high-revenue products lose exclusivity, is a significant concern, but it does not directly impact Syprine due to its niche market position[2].

Pricing and Access

Pricing and access to drugs are critical issues in the life sciences industry, with 47% of executives expecting these factors to significantly impact their strategies in 2025. For Syprine, pricing strategies must balance the need for patient access with the costs associated with developing and maintaining a treatment for a rare disease[2].

Market Projections

Growth Expectations

While the overall life sciences industry is expected to grow, driven by digital transformation and innovation, the specific market for Syprine is likely to remain stable. The demand for Syprine is tied to the prevalence of Wilson disease, which is relatively constant.

Impact of Broader Industry Trends

The life sciences industry is poised for significant transformation in 2025, with advancements in genomics, biomarkers, and personalized medicine. However, these trends are more relevant to broader therapeutic areas rather than niche markets like Wilson disease. The integration of technologies such as AI and increased use of data may enhance operational efficiencies but are unlikely to directly impact the market for Syprine[2].

Safety and Adverse Reactions

Syprine, like any medication, comes with potential adverse reactions. Common side effects include iron deficiency, systemic lupus erythematosus, dystonia, muscular spasm, and myasthenia gravis. Monitoring and managing these side effects are crucial for maintaining patient safety and treatment efficacy[1].

Monitoring Treatment Efficacy

The efficacy of Syprine is monitored through regular assessments of serum free copper concentrations and 24-hour urinary copper excretion. These metrics are essential for ensuring that the treatment is effective and that the patient's condition is stable[1].

Future Outlook

Innovation and R&D

While Syprine itself is not at the forefront of innovative therapies, the broader life sciences industry is focusing heavily on R&D to enhance market positions. For rare diseases like Wilson disease, ongoing research into more precise treatment options and better patient outcomes is crucial. However, any significant advancements in Wilson disease treatment would likely involve new therapies rather than modifications to existing ones like Syprine[2].

Market Expansion and Differentiation

The ability to implement new initiatives and adapt to evolving landscapes will be crucial for differentiation and market expansion in the life sciences industry. For Syprine, this might involve improving patient access, enhancing treatment protocols, and leveraging technological advancements to improve operational efficiencies[2].

Key Takeaways

• Efficacy and Safety: Syprine is an effective chelating agent for treating Wilson disease, with clinical trials demonstrating its non-inferiority to penicillamine.
• Market Position: Syprine operates in a niche market with limited competition but faces broader industry challenges related to pricing and access.
• Future Outlook: The market for Syprine is expected to remain stable, with growth driven by the constant demand for Wilson disease treatments.
• Safety Monitoring: Regular monitoring of serum free copper and urinary copper excretion is essential for maintaining treatment efficacy and patient safety.

FAQs

What is Syprine used for?

Syprine (trientine hydrochloride) is used to treat Wilson disease, a rare genetic disorder characterized by excessive copper accumulation in the body.

How does Syprine work?

Syprine works as a chelating agent, binding to excess copper in the body and facilitating its excretion through the urine.

What are the common side effects of Syprine?

Common side effects include iron deficiency, systemic lupus erythematosus, dystonia, muscular spasm, and myasthenia gravis.

How is the efficacy of Syprine monitored?

The efficacy of Syprine is monitored through regular assessments of serum free copper concentrations and 24-hour urinary copper excretion.

What are the future projections for the Syprine market?

The market for Syprine is expected to remain stable, driven by the constant demand for Wilson disease treatments, although broader industry trends may influence operational efficiencies and patient access.

Sources

1. Rare Disease Advisor: Syprine (Trientine Hydrochloride) - Rare Disease Advisor.
2. Deloitte Insights: 2025 life sciences outlook.
3. GlobeNewswire: Schizophrenia Drug Market Forecast to 2031: The Entry of Adjunctive Therapies to Shape the Schizophrenia Market.
4. PubMed: A randomised, open-label, non-inferiority, phase 3 trial.
5. S&P Global: 2025 Outlooks.