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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR IMIGLUCERASE


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All Clinical Trials for Imiglucerase

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00712348 ↗ Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase Completed Pfizer Phase 3 2008-12-01 This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy.
NCT00712348 ↗ Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase Completed Protalix Phase 3 2008-12-01 This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy.
NCT00875160 ↗ A Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101 Terminated Amicus Therapeutics Phase 1 2009-04-01 This is an open-label study designed to assess if AT2101 is safe in patients with Gaucher disease and how AT2101 gets through the body after it is taken by mouth. The study is being offered to adult patients with type 1 Gaucher disease who are currently receiving a stable dose of enzyme replacement therapy (ERT) with imiglucerase. During the study, subjects will not be receiving ERT (up to 35 days). The study consists of a screening period (~14 days), a treatment period (12 days) and a follow-up period (7 days after last dose). At two points in the study, subjects will be housed in an in-patient treatment facility for 3 days/2 nights to accommodate all necessary blood draws.
NCT00943111 ↗ A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE) Completed Genzyme, a Sanofi Company Phase 3 2009-09-01 This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Imiglucerase

Condition Name

Condition Name for Imiglucerase
Intervention Trials
Gaucher Disease 8
Gaucher Disease, Type 1 4
Gaucher's Disease Type III 2
Gaucher Disease Type 1 1
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Condition MeSH

Condition MeSH for Imiglucerase
Intervention Trials
Gaucher Disease 17
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Clinical Trial Locations for Imiglucerase

Trials by Country

Trials by Country for Imiglucerase
Location Trials
United States 53
United Kingdom 8
Israel 3
France 3
Australia 3
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Trials by US State

Trials by US State for Imiglucerase
Location Trials
Florida 6
California 4
New York 4
Georgia 4
Virginia 4
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Clinical Trial Progress for Imiglucerase

Clinical Trial Phase

Clinical Trial Phase for Imiglucerase
Clinical Trial Phase Trials
Phase 4 1
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Imiglucerase
Clinical Trial Phase Trials
Completed 6
Active, not recruiting 2
Not yet recruiting 2
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Clinical Trial Sponsors for Imiglucerase

Sponsor Name

Sponsor Name for Imiglucerase
Sponsor Trials
Pfizer 4
Protalix 3
Genzyme, a Sanofi Company 3
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Sponsor Type

Sponsor Type for Imiglucerase
Sponsor Trials
Industry 18
Other 4
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Imiglucerase: Clinical Trials, Market Analysis, and Projections

Introduction to Imiglucerase

Imiglucerase, marketed under the brand name Cerezyme, is an enzyme replacement therapy (ERT) used primarily for the treatment of Gaucher disease, a rare genetic disorder. Here, we will delve into the current clinical trials, market analysis, and future projections for this critical drug.

Clinical Trials and Safety Profile

Ongoing Clinical Trials

A recent clinical trial focuses on evaluating the safety and pharmacokinetics of eliglustat in pediatric patients with Gaucher disease, some of whom are also receiving imiglucerase. This study includes pediatric patients aged 2 to 18 years and involves multiple phases, including a screening period, a primary analysis treatment period, a long-term treatment period, and an extension period up to Week 364[1].

Safety and Efficacy

Imiglucerase has undergone rigorous clinical trials and has been approved in multiple countries, including the United States, since its first approval in May 1994. The drug has demonstrated a favorable safety profile and efficacy in treating Type 1 and Type 3 Gaucher disease. It is produced using recombinant DNA technology and has been shown to improve patient outcomes significantly[3][4].

Adverse Reactions and Long-term Studies

Clinical studies and postmarketing reports have identified various adverse reactions associated with imiglucerase, although the frequency and causal relationship of these reactions are not always clear. Long-term studies in animals to evaluate carcinogenic potential have not been performed, but imiglucerase was negative in the Ames test for mutagenesis[4].

Market Analysis

Market Size and Growth

The global imiglucerase market was valued at $1.69 billion in 2023 and is projected to reach $2.57 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.5% during the forecast period. This growth is driven by several factors, including improved patient outcomes, increasing knowledge among medical professionals, technological advancements in enzyme production, and growing incidence of Gaucher disease[2].

Market Segmentation

The imiglucerase market is segmented by type, end-user, disease type, and geography. The hospital segment is a significant portion of the market, offering comprehensive care and advanced medical infrastructure. Clinics and homecare settings also play crucial roles, especially for patients requiring regular infusions while maintaining their daily routines[2].

Geographic Distribution

The market is geographically segmented, with North America expected to dominate due to high healthcare expenditure and advanced medical infrastructure. Europe, particularly countries like France, Germany, and the UK, is also a significant segment driven by stringent healthcare regulations and increased awareness of rare diseases[2].

Technological Developments and Research

Production Advancements

Biotechnology advancements, such as recombinant DNA technology, have enhanced the production process of imiglucerase, making it more economical and of higher quality. This technology allows for large-scale production, increasing the drug's accessibility and affordability[2].

Ongoing Research and Development

Ongoing studies in gene and enzyme replacement therapies continue to provide insights into the optimal use of imiglucerase and potential therapeutic breakthroughs. New formulations and administration techniques are being explored to extend the drug's use to larger patient populations and improve patient adherence[2].

Market Projections

Future Growth Drivers

The market for imiglucerase is expected to grow due to several key drivers:

  • Increasing Awareness and Diagnosis: Growing awareness and early diagnosis of Gaucher disease, especially through genetic testing, are increasing the demand for imiglucerase.
  • Government Incentives: Governments offer subsidies, tax breaks, and extended patent protection to encourage the development and commercialization of orphan drugs like imiglucerase.
  • Public Awareness Campaigns: Global campaigns aimed at patients and medical professionals facilitate diagnosis and access to suitable treatment options, further boosting the demand for imiglucerase[2].

Regional Market Projections

The North American market is expected to continue dominating, while the Asia-Pacific region is also anticipated to grow significantly. The report from QYResearch indicates that the North American and Asia-Pacific markets will see substantial growth from 2023 to 2030, driven by increasing healthcare expenditure and improving medical infrastructure[5].

Key Players and Competitive Landscape

The global imiglucerase market is led by major manufacturers such as Sanofi, Generium, Ligand Pharma, Isu Abxi, and Harvest Moon Pharma. These companies account for a significant portion of the market revenue and are driving innovation through technological advancements and new product developments[5].

Conclusion

Imiglucerase remains a critical drug in the treatment of Gaucher disease, with a strong safety and efficacy profile supported by extensive clinical trials. The market for imiglucerase is poised for significant growth, driven by increasing awareness, technological advancements, and government incentives. As research and development continue, we can expect further improvements in patient outcomes and expanded use of this enzyme replacement therapy.

Key Takeaways

  • Clinical Trials: Ongoing trials are evaluating the safety and pharmacokinetics of imiglucerase in pediatric patients.
  • Market Growth: The global imiglucerase market is projected to grow from $1.69 billion in 2023 to $2.57 billion by 2031.
  • Technological Advancements: Recombinant DNA technology has improved the production process, making imiglucerase more accessible and affordable.
  • Geographic Distribution: North America and Europe are significant markets, with the Asia-Pacific region showing promising growth.
  • Key Drivers: Increasing awareness, government incentives, and public awareness campaigns are driving market growth.

FAQs

What is imiglucerase used for?

Imiglucerase is primarily used for the treatment of Gaucher disease, a rare genetic disorder. It is also indicated for conditions such as anemia, bone diseases, hepatomegaly, myeloid splenomegaly, and thrombocytopenia[3].

Who are the major manufacturers of imiglucerase?

The major global manufacturers of imiglucerase include Sanofi, Generium, Ligand Pharma, Isu Abxi, and Harvest Moon Pharma[5].

What are the key drivers of the imiglucerase market growth?

Key drivers include increasing awareness and diagnosis of Gaucher disease, technological advancements in enzyme production, government incentives, and public awareness campaigns[2].

What is the projected market size of imiglucerase by 2031?

The global imiglucerase market is projected to reach $2.57 billion by 2031, growing at a CAGR of 6.5% from 2023 to 2031[2].

How is imiglucerase produced?

Imiglucerase is produced using recombinant DNA technology in mammalian cell culture, specifically Chinese hamster ovary cells[4].

Sources

  1. Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease. ClinicalTrials.gov.
  2. Imiglucerase Market Size, Share, Growth & Forecast. Verified Market Research.
  3. An In-depth Analysis of Imiglucerase's R&D Progress and Market Trends. Synapse by PatSnap.
  4. Cerezyme (Imiglucerase): Side Effects, Uses, Dosage, Interactions. RxList.
  5. Global Imiglucerase Market Research Report 2024. QYResearch.

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