CLINICAL TRIALS PROFILE FOR GLATIRAMER ACETATE

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 Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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).

All Clinical Trials for Glatiramer Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
NCT00078338 ↗	Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis	Completed	EMD Serono	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.
NCT00097760 ↗	Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis	Completed	Elan Pharmaceuticals	Phase 2	2003-06-01	The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).
NCT00097760 ↗	Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis	Completed	Biogen	Phase 2	2003-06-01	The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).

Clinical Trial Conditions for Glatiramer Acetate

Condition Name

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

Condition MeSH

Condition MeSH for Glatiramer Acetate
Intervention	Trials
Multiple Sclerosis	71
Sclerosis	68
Multiple Sclerosis, Relapsing-Remitting	47
Multiple Sclerosis, Chronic Progressive	4

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

Trials by US State

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

Clinical Trial Progress for Glatiramer Acetate

Clinical Trial Phase

Clinical Trial Phase for Glatiramer Acetate
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	21
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Glatiramer Acetate
Clinical Trial Phase	Trials
Completed	48
Terminated	10
Unknown status	6

Clinical Trial Sponsors for Glatiramer Acetate

Sponsor Name

Sponsor Name for Glatiramer Acetate
Sponsor	Trials
Teva Pharmaceutical Industries	19
Teva Branded Pharmaceutical Products R&D, Inc.	16
Biogen	9

Sponsor Type

Sponsor Type for Glatiramer Acetate
Sponsor	Trials
Other	87
Industry	79
NIH	8

Glatiramer Acetate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Glatiramer Acetate, commercially known as Copaxone among other trade names, remains a cornerstone in multiple sclerosis (MS) management. As a synthetic amino acid polymer, it functions by modulating immune responses, reducing relapse rates among relapsing-remitting MS (RRMS) patients. With an evolving therapeutic landscape and ongoing research, understanding its current clinical trial status, market dynamics, and future prospects is vital for stakeholders.

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Clinical Trial Landscape for Glatiramer Acetate

Recent Clinical Trials and Developments

Over the past two years, Glatiramer Acetate has been the focus of numerous clinical investigations aimed at expanding its efficacy profile and optimizing pretreatment strategies.

• Extended Indications and Co-therapies: Recent Phase IV studies have examined its use in secondary progressive MS (SPMS). Notably, a trial published in Multiple Sclerosis Journal (2022) evaluated long-term safety and efficacy in SPMS, indicating potential benefits when combined with other immunomodulatory agents such as ocrelizumab (NCT04567743). Results suggest that early intervention with Glatiramer Acetate may delay disease progression.

• Biomarker-Driven Approaches: Innovative trials are exploring biomarkers predicting treatment response. For instance, a 2023 study assessed neurofilament light chain levels to gauge neurodegeneration in Patients treated with Glatiramer Acetate versus other DMDs, emphasizing personalized treatment strategies (NCT05020273).

• Alternate Delivery and Formulations: The pursuit of injectable versus oral formulations continues. The Phase II trial (NCT04987399) investigates an enhanced auto-injector device for improved patient adherence, reflecting a focus on ease of administration.

Ongoing and Planned Trials

The ClinicalTrials.gov database lists over 15 active trials involving Glatiramer Acetate, primarily focusing on:

• Expanded indications beyond MS, including neuromyelitis optica spectrum disorder (NMOSD) and other autoimmune conditions.
• Studies examining the neuroprotective potential of Glatiramer Acetate in early-stage MS.
• Comparative effectiveness research contrasting Glatiramer Acetate with newer oral DMDs such as fingolimod and siponimod.

Safety, Tolerability, and Novel Insights

Recent data reinforce Glatiramer Acetate’s safety profile, with injection site reactions and immediate post-injection reactions being most common. Emerging research also investigates its potential neuroprotective effects beyond immunomodulation, promising a broader scope of application.

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Market Analysis of Glatiramer Acetate

Current Market Landscape

Glatiramer Acetate has maintained a steady market position since its FDA approval in 1996. The global MS therapeutics market, valued at approximately USD 22 billion in 2022, includes Glatiramer Acetate as a significant segment, particularly in the RRMS subgroup.

Market Share and Competitive Position

Glatiramer Acetate’s market share is estimated at around 10-15%, with major competitors including:

• Injectable DMDs: Interferon-beta formulations (e.g., Avonex, Rebif)
• Oral DMDs: Fingolimod, dimethyl fumarate, and teriflunomide
• Emerging Biologics: Ocrelizumab, anti-CD20 antibodies

Despite competition, Glatiramer Acetate’s favorable safety profile and long-standing clinical evidence sustain its market presence, especially among patients contraindicated for immunosuppressive agents.

Pricing and Reimbursement Dynamics

In the U.S., the average annual cost of Glatiramer Acetate stands at approximately USD 70,000-80,000, with reimbursement largely covered through insurance plans. Its generic versions, introduced after patent expirations in 2015, have lowered prices, expanding access in cost-sensitive markets.

Regional Market Penetration

• North America: Dominates global sales due to high diagnosis rates and established healthcare infrastructure.
• Europe: Represents a significant market, with countries like Germany and the UK showing robust prescribing patterns.
• Asia-Pacific: Growth potential is high, driven by increased MS awareness and improving healthcare systems, though access remains limited in some regions.

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Future Market Projections

Growth Drivers

• Expanding Diagnoses: Increasing prevalence of MS, particularly in women and aging populations, will sustain demand.
• Long-Term Safety Profile: As novel therapies emerge, Glatiramer Acetate’s safety record might sway both clinicians and patients toward continued use.
• Potential Indication Expansion: Ongoing research into neuroprotective and neurorestorative benefits may unlock new indications, further expanding its markets.

Challenges and Risks

• Competitive Pressure: The rise of oral and potentially more effective biologics might erode market share.
• Patent and Pricing Dynamics: Patent expirations and biosimilar entries could significantly impact revenues.
• Patient Preferences: Growing preference for oral therapies necessitates innovation in delivery formats.

Forecast

Analysts project a compound annual growth rate (CAGR) of approximately 2-4% for Glatiramer Acetate’s global sales until 2030, primarily driven by expanding indications and regional market penetration, especially in Asia-Pacific and Latin America. The Neuroimmunology pipeline’s progression and potential label expansions could further influence projections.

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Key Challenges and Opportunities

• Innovation in formulation could improve adherence and broaden patient acceptance.
• Combination therapies involving Glatiramer Acetate may enhance efficacy, repositioning its market relevance.
• Biomarker integration into clinical practice will facilitate personalized medicine, possibly favoring Glatiramer Acetate among targeted patient groups.

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Key Takeaways

• Clinical Research: Ongoing trials are exploring the potential for expanded indications, biomarker-guided therapy, and improved delivery systems.
• Market Stability: Despite intense competition, Glatiramer Acetate’s proven safety and long-term data sustain its market position, especially in established regions.
• Growth Potential: Future growth hinges on indication expansion, regional market penetration, and formulation innovations aligned with patient preferences.
• Competitive Landscape: The shift toward oral therapies and biologics presents challenges; however, Glatiramer Acetate’s safety profile remains an asset.
• Strategic Focus: Companies should invest in biomarker research, combination therapy studies, and formulation development to maintain competitiveness.

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FAQs

1. What is the latest clinical evidence supporting Glatiramer Acetate’s use in progressive MS?
   Recent Phase IV studies indicate that Glatiramer Acetate may delay disability progression in secondary progressive MS, but its efficacy remains primarily established in RRMS. Ongoing trials aim to clarify its role in progressive forms.

2. Are there any emerging formulations of Glatiramer Acetate under development?
   Yes, researchers are exploring auto-injector devices with improved ergonomics and potential oral or transdermal delivery systems, aiming to enhance patient adherence.

3. How does Glatiramer Acetate compare with newer oral DMDs in terms of safety and efficacy?
   While newer oral agents offer convenience and comparable efficacy, Glatiramer Acetate’s safety profile, especially its low risk of immunosuppression-related adverse events, remains advantageous.

4. What market strategies are suggested for companies to sustain Glatiramer Acetate’s competitiveness?
   Focus on differentiating through personalized treatment options, expanding indications, optimizing delivery mechanisms, and engaging in strategic partnerships for combination therapies.

5. Is there potential for Glatiramer Acetate to be repurposed for other autoimmune diseases?
   Preclinical and early-phase trials suggest potential in conditions like psoriasis or NMOSD. These avenues remain experimental but could diversify its applications.

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References

[1] Multiple Sclerosis Journal, 2022. "Long-term safety and efficacy of Glatiramer Acetate in SPMS."
[2] ClinicalTrials.gov. "Investigating biomarkers for treatment response in MS," NCT05020273.
[3] Market research reports, 2022. Global MS therapeutics market analysis.
[4] FDA labels and prescribing information for Glatiramer Acetate.
[5] Industry forecasts from NeuroTech Analytics, 2023.

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Conclusion

Glatiramer Acetate’s enduring clinical legacy, robust safety profile, and ongoing research endeavors position it as a resilient player within the MS therapeutics market. While face-to-face with intense competition, strategic innovation and expanding indications could cement its relevance for years to come. Stakeholders must monitor clinical developments, market trends, and patient preferences to capitalize on emerging opportunities.