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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR TRIENTINE HYDROCHLORIDE


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All Clinical Trials for Trientine Hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
NCT01178112 ↗ Trientine and Carboplatin in Advanced Malignancies Completed M.D. Anderson Cancer Center Phase 1 2010-07-01 The goal of this clinical research study is to find the highest tolerable dose of the combination of trientine and carboplatin that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
NCT00212355 ↗ Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan. Completed Nobelpharma Phase 3 2005-03-01 The purpose of this long-term study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.
NCT00004339 ↗ Study of Tetrathiomolybdate in Patients With Wilson Disease Completed University of Michigan Phase 3 1994-01-01 OBJECTIVES: Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with trientine therapy as initial treatment in patients with Wilson disease presenting neurologically.
NCT00004339 ↗ Study of Tetrathiomolybdate in Patients With Wilson Disease Completed National Center for Research Resources (NCRR) Phase 3 1994-01-01 OBJECTIVES: Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with trientine therapy as initial treatment in patients with Wilson disease presenting neurologically.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for Trientine Hydrochloride

Condition Name

53110-0.500.511.522.533.544.555.5Wilson DiseaseWilson's DiseaseMelanomaAdvanced Cancers[disabled in preview]
Condition Name for Trientine Hydrochloride
Intervention Trials
Wilson Disease 5
Wilson's Disease 3
Melanoma 1
Advanced Cancers 1
[disabled in preview] 0
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Condition MeSH

82110012345678Hepatolenticular DegenerationMacular EdemaDiabetes MellitusHypertrophy[disabled in preview]
Condition MeSH for Trientine Hydrochloride
Intervention Trials
Hepatolenticular Degeneration 8
Macular Edema 2
Diabetes Mellitus 1
Hypertrophy 1
[disabled in preview] 0
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Clinical Trial Locations for Trientine Hydrochloride

Trials by Country

+
Trials by Country for Trientine Hydrochloride
Location Trials
United States 9
United Kingdom 5
Germany 4
Poland 2
Belgium 2
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Trials by US State

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Trials by US State for Trientine Hydrochloride
Location Trials
Connecticut 3
Texas 2
Michigan 2
California 1
North Carolina 1
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Clinical Trial Progress for Trientine Hydrochloride

Clinical Trial Phase

7.7%23.1%23.1%46.2%00.511.522.533.544.555.566.5Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for Trientine Hydrochloride
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2 3
[disabled in preview] 6
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Clinical Trial Status

50.0%16.7%16.7%16.7%022.533.544.555.56CompletedActive, not recruitingWithdrawn[disabled in preview]
Clinical Trial Status for Trientine Hydrochloride
Clinical Trial Phase Trials
Completed 6
Active, not recruiting 2
Withdrawn 2
[disabled in preview] 2
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Clinical Trial Sponsors for Trientine Hydrochloride

Sponsor Name

trials0112233Univar BVOrphalanUniversity of British Columbia[disabled in preview]
Sponsor Name for Trientine Hydrochloride
Sponsor Trials
Univar BV 3
Orphalan 2
University of British Columbia 2
[disabled in preview] 2
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Sponsor Type

47.8%47.8%0-10123456789101112OtherIndustryNIH[disabled in preview]
Sponsor Type for Trientine Hydrochloride
Sponsor Trials
Other 11
Industry 11
NIH 1
[disabled in preview] 0
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Trientine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Trientine hydrochloride is a crucial medication in the treatment of Wilson’s Disease, a rare genetic disorder characterized by excessive copper accumulation in the body, particularly affecting the liver and brain. This article provides an update on the clinical trials, market analysis, and future projections for trientine hydrochloride.

Clinical Trials Update

CHELATE Trial

One of the significant clinical trials involving trientine hydrochloride is the CHELATE trial conducted by Orphalan SA. This Phase 3, multicentre, randomised, open-label, active-controlled, non-inferiority study compared trientine tetrahydrochloride with d-Penicillamine in patients with stable Wilson’s Disease. The trial involved 53 adult patients who were followed for a baseline period of 12 weeks before being randomised to either trientine tetrahydrochloride or d-Penicillamine. The primary endpoint was serum non-ceruloplasmin copper (NCC) at 24 weeks post-randomisation. The results indicated that trientine tetrahydrochloride offers a differentiated tolerability profile and is a safe and effective alternative to d-Penicillamine for maintenance therapy in Wilson’s Disease patients[1].

Efficacy and Safety

The CHELATE trial and other studies have consistently shown that trientine hydrochloride is effective in patients intolerant to d-Penicillamine. For instance, a large retrospective analysis involving 405 patients with Wilson’s Disease demonstrated that 68.9% of patients with hepatic symptoms and 51.0% of patients with neurologic symptoms showed improvement when treated with trientine as second-line therapy[3].

Additional Studies

Apart from Wilson’s Disease, trientine hydrochloride has been explored in other clinical contexts. The TRACER-HF trial investigated the effects of trientine-HCL in patients with heart failure with reduced ejection fraction (HFrEF). The study found that the addition of trientine-HCL to usual care was well-tolerated and significantly reduced NT-proBNP levels at four and eight weeks, particularly at the 300 mg dose[4].

Market Analysis

Market Size and Growth

The global trientine hydrochloride market has experienced rapid growth in recent years. As of 2022, the market was valued at USD 715.2 Million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.9% between 2023 and 2030, reaching USD 1314.01 Million by 2030[5].

Segmentation

The market is segmented based on formulation type (capsules, tablets, injectables, powder, etc.), application (Wilson’s Disease, copper overload, other rare conditions), and distribution channels (pharmacy, hospital pharmacies, online pharmacies, etc.). Wilson’s Disease is the leading indication, holding over 58% of the market share in 2022. Adult patients dominate the demand, holding over 62% of the market share. The oral capsules segment is expected to post the highest CAGR during the projection period[5].

Geographical Distribution

North America is a significant contributor to the trientine hydrochloride market, holding over one-third of the market share in 2022. Other key regions include Europe, Asia-Pacific, South America, and the Middle-East and Africa[5].

Key Players

The market is dominated by several key players, including Albany Molecular Research Inc, SMIQ Pharma, Sigma-Aldrich Co. LLC, Valeant Pharmaceuticals International Inc, and others. These companies are driving innovation in treatment formulations and delivery methods[5].

Market Drivers and Restraints

Drivers

The increasing prevalence of Wilson’s Disease and advancements in treatment formulations and delivery methods are major drivers of the trientine hydrochloride market. Personalized medicine and pharmacogenomics also present opportunities for growth, especially in emerging markets[5].

Restraints

Despite the positive outlook, the market faces several restraints. Limited disease awareness and diagnosis, high treatment costs, and accessibility issues are significant challenges. These factors can hinder the widespread adoption of trientine hydrochloride, particularly in regions with limited healthcare resources[5].

Projections and Future Outlook

Market Growth

The trientine hydrochloride market is poised for significant growth, driven by increasing demand for effective treatments for Wilson’s Disease and other conditions involving copper overload. The projected CAGR of 7.9% between 2023 and 2030 indicates a robust expansion in the market[5].

Emerging Markets

Expansion into emerging markets, particularly in regions with growing healthcare infrastructure, is expected to play a crucial role in the future growth of the trientine hydrochloride market. Personalized medicine and pharmacogenomics are also anticipated to drive innovation and adoption[5].

Regulatory Approvals

The approval of trientine hydrochloride in various regions, such as the EU where Cuprior™ is approved for patients intolerant to d-Penicillamine, will continue to support market growth. Regulatory submissions, such as the one for Mar-Trientine in Canada, further solidify the drug's position in the market[1][3].

"Despite its poor safety profile, d-Penicillamine is the only approved first line therapy in Wilson’s Disease. The CHELATE study showed that patients on d-Penicillamine can be safely switched to trientine tetrahydrochloride, without compromising efficacy." - Dr. Naseem Amin, Chief Executive Officer at Orphalan[1].

Key Takeaways

  • Clinical Efficacy: Trientine hydrochloride has shown significant efficacy as a second-line treatment for Wilson’s Disease patients intolerant to d-Penicillamine.
  • Market Growth: The global trientine hydrochloride market is expected to grow at a CAGR of 7.9% between 2023 and 2030.
  • Segmentation: Wilson’s Disease is the leading indication, and adult patients dominate the demand.
  • Geographical Distribution: North America is a major contributor to the market.
  • Drivers and Restraints: Increasing prevalence of Wilson’s Disease and advancements in treatment formulations are key drivers, while limited disease awareness and high treatment costs are significant restraints.

FAQs

What is the primary indication for trientine hydrochloride?

Trientine hydrochloride is primarily indicated for the treatment of patients with Wilson’s Disease who are intolerant to d-Penicillamine.

What are the key findings from the CHELATE trial?

The CHELATE trial showed that trientine tetrahydrochloride offers a differentiated tolerability profile and is a safe and effective alternative to d-Penicillamine for maintenance therapy in Wilson’s Disease patients.

How is the trientine hydrochloride market expected to grow?

The global trientine hydrochloride market is expected to grow at a CAGR of 7.9% between 2023 and 2030, reaching USD 1314.01 Million by 2030.

What are the major market drivers for trientine hydrochloride?

The increasing prevalence of Wilson’s Disease and advancements in treatment formulations and delivery methods are major drivers of the trientine hydrochloride market.

What are the significant restraints for the trientine hydrochloride market?

Limited disease awareness and diagnosis, high treatment costs, and accessibility issues are significant challenges facing the trientine hydrochloride market.

Sources

  1. Orphalan Announces Positive Top Line Data with Trientine Tetrahydrochloride for Maintenance Patients with Wilson’s Disease. Biospace.
  2. Trientine Hydrochloride Report on Market Size, Trends and Forecast. Market Research Intellect.
  3. Summary Basis of Decision for Mar-Trientine. Health Canada.
  4. TRACER-HF: Effects of Trientine-HCL in Patients With HFrEF. American College of Cardiology.
  5. Trientine Hydrochloride Market Share, Size and Forecast 2030. Credence Research.

More… ↓

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