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Glatiramer | CAS No: 28704-27-0 | GMP-certified suppliers
A medication that provides immunomodulatory treatment for relapsing forms of multiple sclerosis, reducing relapse rates and supporting disease management in adults.
Therapeutic categories
Primary indications
- Glatiramer acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Product Snapshot
- Glatiramer is a parenteral injectable peptide formulated as a solution and powder for injection
- It is primarily used for the treatment of relapsing forms of multiple sclerosis in adults
- Glatiramer is approved for use in the US and Canada, with both approved and investigational statuses
Clinical Overview
Pharmacologically, glatiramer acetate acts as an immunomodulatory agent. Although its exact mechanism of action remains incompletely understood, it is believed to modify the immune response implicated in MS pathogenesis. The drug is structurally designed to mimic myelin basic protein (MBP), a key autoantigen in MS. It binds to major histocompatibility complex (MHC) class II molecules on antigen-presenting cells, thereby inhibiting MBP-induced activation. Moreover, glatiramer acetate promotes a shift from pro-inflammatory T helper 1 (Th1) responses to anti-inflammatory T helper 2 (Th2) profiles, enhancing secretion of cytokines such as IL-4, IL-5, IL-10, and TGF-β. It also induces regulatory T-cell populations that contribute to immunosuppression and reduced demyelination.
Following administration, intact or partially hydrolyzed glatiramer acetate is absorbed into lymphatic circulation, reaching lymph nodes where immune modulation occurs. Clinical studies have demonstrated a reduction in annualized relapse rates in relapsing-remitting MS at dosing regimens of 20 mg daily or 40 mg three times weekly. Compared to placebo and interferon beta-1a, glatiramer acetate shows significant efficacy in reducing relapse frequency.
Safety considerations include immediate post-injection reactions seen in approximately 16% of patients, typically transient but occasionally requiring emergency care. Other adverse events reported include chest pain, injection site reactions such as localized lipoatrophy or skin necrosis, and rare cases of hepatic injury. Given its immunomodulatory effects, careful monitoring for infections and immune compromise is advised during therapy.
Glatiramer acetate was first approved by the US FDA in 1996 and a generic version became available in 2017. It is recognized as a first-line therapy alongside agents such as interferon beta, teriflunomide, and dimethyl fumarate.
From an API sourcing and quality perspective, the heterogeneous nature of glatiramer acetate necessitates stringent controls on peptide composition and molecular weight distribution to ensure batch-to-batch consistency. Suppliers must comply with good manufacturing practices (GMP) and provide comprehensive quality documentation, including characterization data and impurity profiles. Analytical methods should confirm the molar fractions of constituent amino acids and peptide integrity to support regulatory acceptance and clinical efficacy.
Identification & chemistry
| Generic name | Glatiramer |
|---|---|
| Molecule type | Biotech |
| CAS | 28704-27-0 |
| UNII | U782C039QP |
| DrugBank ID | DB05259 |
Pharmacology
| Summary | Glatiramer acetate is a synthetic polypeptide that modulates immune responses implicated in multiple sclerosis (MS) by binding to major histocompatibility complex (MHC) class II molecules and altering antigen presentation. It shifts the immune profile from pro-inflammatory Th1 activity toward an anti-inflammatory Th2 response and induces regulatory T-cell populations. These immunomodulatory effects aim to reduce demyelination and neurodegeneration associated with relapsing forms of MS. |
|---|---|
| Mechanism of action | The mechanism of action of glatiramer acetate has not been fully elucidated; however, it is thought to act by modifying immune processes involved in the pathogenesis of multiple sclerosis (MS). MS is characterized by damage to the myelin layer that covers nerve cells (demyelination) and axonal degeneration. Also, it has been suggested that the myelin basic protein (MBP), a myelin autoantigen, plays a role in the development of MS. Several mechanisms of action have been proposed. For instance, glatiramer acetate binds strongly to several major histocompatibility complex (MHC) class II molecules on MBP-specific antigen-presenting cells, preventing MBP from stimulating these cells. Glatiramer acetate also has the ability to shift the immune system from a pro-inflammatory to an anti-inflammatory pattern. It inhibits the secretion of pro-inflammatory cytokines (IL-2, IL-12, IFNγ, TNF) released by T helper 1 (Th1) cells, and induces T helper 2 (Th2) suppressor cells that are able to cross the blood-brain barrier and produce anti-inflammatory cytokines (IL-4, IL-5, IL-13, IL-10, TGF-β). It has also been suggested that glatiramer acetate induces the production of T-regulatory cells associated with the suppression of MS, such as CD4<sup>+</sup>, CD8<sup>+</sup> and CD4<sup>+</sup>CD25<sup>+</sup> cells. |
| Pharmacodynamics | Glatiramer acetate is a mix of synthetic polypeptides that includes four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. This drug is indicated for the treatment of relapsing multiple sclerosis (MS) due to its ability to modify immune processes involved in the pathogenesis of this disease. Intact and large fragments of glatiramer acetate are recognized by glatiramer acetate-reactive antibodies. _In vitro_ and _in vivo_ studies suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery. A fraction of intact or partially hydrolyzed glatiramer acetate enters lymphatic circulation and is able to reach the lymph nodes. Compared to placebo and IFNb-1a, patients with relapsing-remitting MS receiving 20 mg/mL of glatiramer acetate once a day had significantly lower annualized relapse rates. Similar outcomes were observed in MS patients taking 40 mg/mL of glatiramer acetate three times a week. Some of the patients treated with glatiramer acetate (approximately 16%) have developed immediate post-injection reactions. Most of these cases are transient and do not require treatment, but there have been reports of patients requiring emergency medical care. Patients taking glatiramer acetate may also experience chest pain, injection site side effects such as localized lipoatrophy and skin necrosis, and hepatic injury. Since glatiramer acetate modifies immune response, it may interfere with immune function. |
Targets
| Target | Organism | Actions |
|---|---|---|
| HLA class II histocompatibility antigen, DRB1-1 beta chain | Humans | binder |
| HLA class II histocompatibility antigen, DRB1-15 beta chain | Humans | binder |
| HLA class II histocompatibility antigen, DRB1-4 beta chain | Humans | binder |
ADME / PK
| Absorption | After subcutaneous administration, most glatiramer acetate is rapidly absorbed and hydrolyzed locally. In 7 out of 9 healthy volunteers that received 60 mg of glatiramer acetate subcutaneously, the C<sub>max</sub> ranged from 69 to 126 ng/mL, while the other two subjects showed significantly higher values (605 and 301 ng/mL). AUC values showed great variability, ranging from 1,644 to 67,532 min⋅ng/mL. The T<sub>max</sub> of glatiramer acetate went from 15 to 30 min, and in all subjects, glatiramer acetate levels returned to baseline after 30-60 min. In healthy volunteers given 60 mg of glatiramer acetate subcutaneously, immunorecognizable fragments were no longer detected after 24 hours. The systemic bioavailability of glatiramer acetate is considered to be minimal. The pharmacokinetic parameters of glatiramer acetate in multiple sclerosis (MS) patients have not been determined. |
|---|---|
| Half-life | Not available. |
| Protein binding | Glatiramer acetate is highly bound to plasma proteins. |
| Metabolism | Glatiramer acetate is a mixture of synthetic polypeptides hydrolyzed by proteases. |
| Route of elimination | _In vivo_ studies have shown that glatiramer acetate is mainly excreted through urine. |
| Volume of distribution | Not available. |
| Clearance | Not available. |
Formulation & handling
- Glatiramer is a biotech peptide administered via subcutaneous or parenteral injection, not suitable for oral delivery.
- The API is provided both as a lyophilized powder for reconstitution and as a ready-to-use solution, requiring sterile handling practices.
- Formulation stability considerations include protection from moisture and adherence to cold chain storage due to peptide sensitivity.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is in a mature market phase in Canada and the United States, with initial patents having expired in 2014 and 2015, while additional patents protecting certain aspects remain in effect in the US until 2030. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The Glatiramer manufacturing landscape includes multiple originator companies involved primarily in packaging, with products marketed mainly in the US and Canada under the branded name Copaxone. Several patents are active in the US through 2030, indicating ongoing patent protection and limited generic competition currently in these major markets. |
|---|
Safety
| Toxicity | In mice given 60 mg/kg/day of glatiramer acetate subcutaneously (15 times the human therapeutic dose of 20 mg/day on a mg/m<sup>2</sup> basis), glatiramer acetate did not increase systemic neoplasms. Similar results were obtained in rats given 30 mg/kg/day of glatiramer acetate subcutaneously (15 times the human therapeutic dose of 20 mg/day on a mg/m<sup>2</sup> basis). _In vitro_ studies suggest that glatiramer acetate is non-mutagenic. No adverse effects were observed on reproductive or developmental parameters during _in vivo_ studies. Overdose information regarding glatiramer acetate is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as hepatic injury, lipoatrophy and skin necrosis at the injection site. Symptomatic and supportive measures are recommended. |
|---|
- Glatiramer acetate demonstrated no mutagenic potential in vitro and no increase in systemic neoplasms in high-dose animal studies
- No adverse reproductive or developmental effects were observed in vivo
- Overdose may lead to severe adverse effects including hepatic injury, lipoatrophy, and injection site necrosis
Glatiramer Acetate is a type of Immunosuppressants
Immunosuppressants are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in medical treatments. These substances are designed to suppress or weaken the immune system's response, making them invaluable in various therapeutic applications.
Immunosuppressants find extensive use in the management of autoimmune diseases, organ transplantation, and the prevention of rejection reactions. By modulating the immune system's activity, these APIs help control excessive immune responses that can lead to tissue damage and chronic inflammation.
There are different classes of immunosuppressants, including corticosteroids, calcineurin inhibitors, antimetabolites, and biologics. Each class targets specific immune pathways to achieve the desired therapeutic effect. Corticosteroids, for instance, are known for their potent anti-inflammatory properties, making them effective in managing conditions such as rheumatoid arthritis and asthma.
Calcineurin inhibitors like cyclosporine and tacrolimus act by inhibiting the activity of calcineurin, a protein involved in immune cell activation. These drugs are commonly used in organ transplantation to prevent the immune system from attacking the transplanted organ.
Antimetabolites interfere with DNA synthesis and cell proliferation, thereby dampening immune responses. They are often prescribed for conditions like psoriasis and rheumatoid arthritis.
Biologic immunosuppressants, such as monoclonal antibodies, target specific immune cells or molecules involved in the disease process. They have revolutionized the treatment of autoimmune diseases like rheumatoid arthritis, Crohn's disease, and psoriasis.
Immunosuppressants require careful administration and monitoring due to their potential side effects and interactions with other medications. Close collaboration between healthcare professionals, pharmacists, and patients is essential to ensure the safe and effective use of these APIs in various therapeutic settings.
Overall, immunosuppressants represent a critical category of pharmaceutical APIs that significantly contribute to improving patients' quality of life by controlling the immune system's activity and managing various autoimmune conditions and transplantation outcomes.
Glatiramer Acetate (Immunosuppressants), classified under Immunomodulators
Immunomodulators, a category of pharmaceutical active pharmaceutical ingredients (APIs), are substances that help regulate and modify the immune response of an individual. These compounds play a crucial role in treating various immune-related disorders and diseases. Immunomodulators work by either enhancing or suppressing the immune system, depending on the specific condition being treated.
Immunomodulators are used in the treatment of autoimmune disorders, such as rheumatoid arthritis, multiple sclerosis, and psoriasis. By suppressing the immune system, these APIs help reduce the overactive immune response associated with these conditions, thereby alleviating symptoms and preventing further damage to the body's tissues.
On the other hand, immunomodulators are also employed to boost the immune system in cases of immunodeficiency disorders. These APIs stimulate the immune response, enabling the body to better fight off infections and diseases. Additionally, immunomodulators are utilized in the prevention and treatment of organ transplant rejection, where they help modulate the immune system to accept the transplanted organ.
The development and production of immunomodulators require rigorous testing and quality control to ensure their safety and efficacy. Pharmaceutical companies carefully formulate these APIs into various dosage forms, including tablets, capsules, injections, and topical preparations, to cater to different patient needs.
In summary, immunomodulators form a vital category of pharmaceutical APIs that regulate and modify the immune system. With their ability to modulate immune responses, these compounds contribute significantly to the management and treatment of various immune-related disorders and diseases, improving the quality of life for many patients.
Glatiramer Acetate API manufacturers & distributors
Compare qualified Glatiramer Acetate API suppliers worldwide. We currently have 12 companies offering Glatiramer Acetate API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| AMBIOPHARM | Producer | United States | Unknown | CoA, USDMF | 10 products |
| Biocon | Producer | India | India | CoA, GMP, WC | 36 products |
| Chemi S.p.A. | Producer | Italy | Italy | CoA, GMP | 18 products |
| Cipla | Producer | India | India | CoA, GMP, WC | 164 products |
| Corden Pharma | Producer | Germany | United States | CoA, GMP, USDMF | 45 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Hybio Pharmaceutical | Producer | China | China | CoA, USDMF | 8 products |
| Hybio Pharmaceutical Co L... | Producer | China | China | BSE/TSE, CoA, MSDS, USDMF | 34 products |
| Jiwan Pharmaceutical Tech... | Producer | China | China | CoA, USDMF | 8 products |
| Natco Pharma | Producer | India | India | CoA, FDA, GMP, WC | 40 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 157 products |
| USV | Producer | India | India | CoA, FDA, GMP, WC | 35 products |
When sending a request, specify which Glatiramer Acetate API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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