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Copaxone (GLATIRAMER ACETATE)

Copaxone (generic name: GLATIRAMER ACETATE) is a Small molecule drug developed by Teva. It is currently FDA-approved (first approved 1996) for Multiple sclerosis.

Copaxone works by modulating the immune system's response to reduce inflammation in the central nervous system.

Copaxone (Glatiramer Acetate) is a medication originally developed by TEVA PHARMS USA and currently owned by the same company. It is used to treat multiple sclerosis, a chronic autoimmune disease affecting the central nervous system. As a small molecule modality, its exact mechanism of action is not fully understood, but it is believed to work by modulating the immune system's response. Copaxone is off-patent, with six generic manufacturers available, and was first approved by the FDA in 1996. Despite its commercial status, it remains a widely prescribed treatment for multiple sclerosis.

At a glance

Mechanism of action

The mechanism(s) by which glatiramer acetate exerts its effects in patients with MS are not fully understood. However, glatiramer acetate is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental autoimmune encephalomyelitis, condition induced in animals through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS. Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery.Because glatiramer acetate can modify immune functions, concerns exist about its potential to alter naturally-occurring immune responses. There is no evidence that glatiramer acetate does this, but this has not been systematically ev

Approved indications

• Multiple sclerosis

Common side effects

• Injection site reactions
• Vasodilatation
• Rash
• Dyspnea
• Chest pain
• Lymphadenopathy
• Palpitations
• Tachycardia
• Eye Disorder
• Diplopia
• Nausea
• Vomiting

Key clinical trials

• A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
• Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS (PHASE3)
• Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis (NA)
• Immune Profiles in Multiple Sclerosis (MS) Patients and Healthy Volunteers Through Thoracic Duct Cannulation (NA)
• A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT (PHASE3)
• A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
• A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
• Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (NA)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Copaxone CI brief — competitive landscape report
• Copaxone updates RSS · CI watch RSS
• Teva portfolio CI

Frequently asked questions about Copaxone

Related

• Manufacturer: Teva — full pipeline
• Therapeutic area: All drugs in Immunology
• Indication: Drugs for Multiple sclerosis

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing