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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR GLATIRAMER ACETATE


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505(b)(2) Clinical Trials for Glatiramer Acetate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
New Formulation NCT01578785 ↗ An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Terminated Teva Branded Pharmaceutical Products R&D, Inc. Phase 3 2012-03-01 This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).
New Formulation NCT01578785 ↗ An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Terminated Teva Pharmaceutical Industries Phase 3 2012-03-01 This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

All Clinical Trials for Glatiramer Acetate

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00078338 ↗ Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis Completed Pfizer Phase 4 2004-02-16 The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.
NCT00071838 ↗ Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2003-10-30 This study will examine the safety of Zenapax (daclizumab) in patients with multiple sclerosis (MS). MS is thought to be caused by an over-reactive immune response. T-lymphocytes (cells of the immune system), are thought to damage myelin, a substance that covers the nerve and parts of the spinal cord and is damaged in patients with MS. Interleukin-2 is a natural substance in the body that is necessary for the growth of T-lymphocytes. Zenapax is a genetically engineered antibody that blocks the activity of interleukin-2 and thus interferes with the growth of lymphocytes. Therefore, Zenapax may prevent some of the damage to myelin that occurs in multiple sclerosis. Patients between 18 and 65 years of age with relapsing remitting MS may be eligible for this study. Patients with secondary-progressive or primary progressive MS may not participate. Candidates will be screened with a complete neurological and medical evaluation and review of medical records. Participants will undergo the following tests and procedures: - Baseline evaluation: Participants have four magnetic resonance imaging (MRI) scans over a 3-month period to assess disease activity. For the MRI scans, the patient lies on a table that slides into the scanner - a narrow metal cylinder with a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Only patients with activity at or above a certain level are eligible to continue with the treatment phase of the study. - Zenapax treatment: Patients receive intravenous (through a vein) infusions of Zenapax. The first two infusions are 2 weeks apart, followed by 13 monthly infusions. - MRI scans: Patients undergo MRI scanning before every infusion to evaluate disease activity and identify new brain lesions. - Blood and urine tests: Blood and urine samples are collected at each clinic visit for routine laboratory evaluations, immunologic study, and genetic testing to determine a predisposition for responding to Zenapax treatment. - Lumbar puncture (spinal tap): This procedure will be done during the last month before starting treatment and during the seventh month of treatment to examine immune changes that occur in the cerebrospinal fluid (CSF), which circulates through and surrounds the brain and spinal cord. A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle. - Skin test: A needle is placed just under the skin is done to assess the patient's immune status to common antigens such as tetanus, mumps and candida. - Lymphocytopheresis: Lymphocytes are collected three times - once during the last month of baseline before starting treatment, once during the fifth month of treatment, and once during the last month of treatment - for immunologic study. Blood is collected through a needle in an arm vein in a similar way to donating blood. The blood flows from the vein through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The lymphocytes are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body, either through the same needle or through another needle in the other arm.
NCT00039988 ↗ Treatment of Multiple Sclerosis With Copaxone and Albuterol Completed Autoimmunity Centers of Excellence N/A 2001-11-01 The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.
NCT00039988 ↗ Treatment of Multiple Sclerosis With Copaxone and Albuterol Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 2001-11-01 The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for Glatiramer Acetate

Condition Name

28151390051015202530Multiple SclerosisRelapsing Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting[disabled in preview]
Condition Name for Glatiramer Acetate
Intervention Trials
Multiple Sclerosis 28
Relapsing Remitting Multiple Sclerosis 15
Relapsing-Remitting Multiple Sclerosis 13
Multiple Sclerosis, Relapsing-Remitting 9
[disabled in preview] 0
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Condition MeSH

7168470010203040506070Multiple SclerosisSclerosisMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic Progressive[disabled in preview]
Condition MeSH for Glatiramer Acetate
Intervention Trials
Multiple Sclerosis 71
Sclerosis 68
Multiple Sclerosis, Relapsing-Remitting 47
Multiple Sclerosis, Chronic Progressive 4
[disabled in preview] 0
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Clinical Trial Locations for Glatiramer Acetate

Trials by Country

+
Trials by Country for Glatiramer Acetate
Location Trials
United States 424
Canada 33
Germany 33
Spain 30
Brazil 16
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Trials by US State

+
Trials by US State for Glatiramer Acetate
Location Trials
California 22
New York 20
Ohio 19
Illinois 17
Florida 17
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Clinical Trial Progress for Glatiramer Acetate

Clinical Trial Phase

26.2%32.3%38.5%002468101214161820222426Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Glatiramer Acetate
Clinical Trial Phase Trials
Phase 4 17
Phase 3 21
Phase 2/Phase 3 2
[disabled in preview] 25
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Clinical Trial Status

68.6%14.3%8.6%8.6%05101520253035404550CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for Glatiramer Acetate
Clinical Trial Phase Trials
Completed 48
Terminated 10
Unknown status 6
[disabled in preview] 6
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Clinical Trial Sponsors for Glatiramer Acetate

Sponsor Name

trials02468101214161820Teva Pharmaceutical IndustriesTeva Branded Pharmaceutical Products R&D, Inc.Biogen[disabled in preview]
Sponsor Name for Glatiramer Acetate
Sponsor Trials
Teva Pharmaceutical Industries 19
Teva Branded Pharmaceutical Products R&D, Inc. 16
Biogen 9
[disabled in preview] 5
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Sponsor Type

50.0%45.4%00102030405060708090OtherIndustryNIH[disabled in preview]
Sponsor Type for Glatiramer Acetate
Sponsor Trials
Other 87
Industry 79
NIH 8
[disabled in preview] 0
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Glatiramer Acetate: Clinical Trials, Market Analysis, and Projections

Introduction to Glatiramer Acetate

Glatiramer acetate, commonly known by its brand name Copaxone®, is a disease-modifying therapy (DMT) used primarily for the treatment of relapsing forms of multiple sclerosis (RMS). It has been a cornerstone in MS treatment for over two decades due to its efficacy in reducing relapse rates and slowing disease progression.

Recent Clinical Trials Update

GA Depot Phase III Trial

A significant recent development in the clinical landscape of glatiramer acetate is the GA Depot Phase III trial conducted by Mapi Pharma. This multinational, multicenter, randomized, double-blind, placebo-controlled study evaluated the safety, efficacy, and tolerability of a long-acting depot injectable formulation of glatiramer acetate (GA Depot 40 mg) administered once every four weeks.

  • Primary Endpoint: The study met its primary endpoint, demonstrating that GA Depot 40 mg significantly reduced the annualized relapse rate (ARR) by 30.1% compared to placebo (p=0.0066)[1].
  • Patient Enrollment: The study involved 1,016 patients across 112 sites, with participants receiving either GA Depot 40 mg or placebo via intramuscular injection once every four weeks for a total of 13 doses[1].
  • Future Implications: The positive results suggest that GA Depot could offer a more convenient dosing regimen, potentially improving patient compliance and adherence. Mapi Pharma and its partner Viatris plan to work with regulatory authorities to determine the next steps for commercialization[1].

Mechanism of Action and Efficacy

Glatiramer acetate's exact mechanism of action is not fully understood, but it is believed to involve several immunomodulatory and neuroprotective effects:

  • Immunomodulation: It is thought to compete with myelin autoantigens at the major histocompatibility complex class II binding site on antigen-presenting cells, induce antigen-specific Th2 T cells, and stimulate neurotrophic factor secretion by immune cells[3].
  • Clinical Efficacy: Across multiple randomized controlled clinical trials, glatiramer acetate has consistently shown efficacy in reducing relapse rates and MRI disease activity, as well as slowing disability progression in patients with RMS[3][4].

Market Analysis

Current Market Size and Growth

The glatiramer acetate market has seen significant growth driven by several factors:

  • Market Size: The market was valued at USD 3.5 billion in 2023 and is expected to reach USD 6.9 billion by 2031, growing at a CAGR of 8.8% from 2024 to 2031[2].
  • Growth Drivers: The increasing incidence of multiple sclerosis, advancements in drug formulations, higher treatment rates due to improved diagnostic methods, and supportive government policies and healthcare reforms are key drivers of market growth[2][5].

Market Segmentation

The market is segmented based on various factors:

  • Application: Injectable solutions, pre-filled syringes, lyophilized powders, and auto-injector devices[2].
  • Product: Multiple sclerosis treatment, neurological disorders, and immune modulation[2].
  • Geographical Regions: North America, Europe, Asia-Pacific, South America, and Middle-East and Africa[2].

Generic vs. Branded Market

The introduction of generic glatiramer acetate has significantly impacted the market:

  • Generic Uptake: Generic glatiramer acetate claims have grown substantially, reaching approximately 30% of the market share, while branded claims have declined by more than half over the past few years[3].
  • Payer Trends: Medicare and commercial insurers have seen the greatest decline in branded claims and the highest uptake of generic claims[3].

Projections and Future Outlook

Market Growth Projections

  • The glatiramer acetate market is expected to continue growing, driven by the increasing demand for disease-modifying therapies and improvements in healthcare systems globally. By 2030, the market is projected to reach USD 5.93 billion with a CAGR of 5.1% from 2023 to 2030[5].
  • Regional Opportunities: The report highlights lucrative opportunities at the country level, with detailed insights into product pricing, penetration, and market dynamics[5].

Regulatory and Commercial Implications

  • The positive results from the GA Depot Phase III trial are expected to pave the way for its commercialization, offering patients a more convenient treatment option. Mapi Pharma and Viatris will work with regulatory authorities to expedite this process[1].
  • Competitive Landscape: The market is competitive, with major players continually innovating and expanding their product offerings. The report provides a detailed competitive landscape, including SWOT analysis and strategic approaches of key players[5].

Key Takeaways

  • Clinical Efficacy: Glatiramer acetate, including the new GA Depot formulation, has demonstrated significant efficacy in reducing relapse rates and slowing disease progression in RMS patients.
  • Market Growth: The market is expected to grow substantially, driven by increasing demand, advancements in drug formulations, and supportive healthcare policies.
  • Generic Impact: The introduction of generic glatiramer acetate has significantly altered the market dynamics, with generics gaining a substantial market share.
  • Future Outlook: The GA Depot formulation is poised to offer a more convenient treatment option, potentially improving patient compliance and adherence.

FAQs

What is the primary mechanism of action of glatiramer acetate?

Glatiramer acetate's mechanism of action involves immunomodulation and neuroprotection, including competition with myelin autoantigens, induction of antigen-specific Th2 T cells, and stimulation of neurotrophic factor secretion by immune cells[3].

What are the key findings from the GA Depot Phase III trial?

The GA Depot Phase III trial showed that the long-acting depot injectable formulation of glatiramer acetate (GA Depot 40 mg) significantly reduced the annualized relapse rate by 30.1% compared to placebo, meeting its primary endpoint[1].

How is the glatiramer acetate market expected to grow in the coming years?

The glatiramer acetate market is expected to grow at a CAGR of 8.8% from 2024 to 2031, reaching USD 6.9 billion by 2031, driven by increasing demand, advancements in drug formulations, and supportive healthcare policies[2].

What impact have generic versions of glatiramer acetate had on the market?

Generic glatiramer acetate has significantly impacted the market, with generic claims growing to approximately 30% of the market share, while branded claims have declined by more than half over the past few years[3].

Who are the major players in the glatiramer acetate market?

Major players include Teva Pharmaceuticals, Mapi Pharma, and Viatris, among others. These companies are continually innovating and expanding their product offerings in the MS treatment market[5].

Sources

  1. Mapi Pharma Announces Positive Top-Line Results from GA Depot Phase III Trial for Relapsing Forms of Multiple Sclerosis (RMS). Mapi Pharma.
  2. Glatiramer Acetate Market Size, Share | Growth Report, 2031. Market Research Intellect.
  3. Prescription Trends in Branded Versus Generic Glatiramer Acetate. Medica Musc.
  4. Learn How COPAXONE® Works to Treat Relapsing MS. Copaxone.
  5. Glatiramer Acetate Market Size, Growth And Trends | Forecast [2030]. Verified Market Reports.

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