Eptinezumab API Manufacturers
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Looking for Eptinezumab API 1644539-04-7?
- Description:
- Here you will find a list of producers, manufacturers and distributors of Eptinezumab. You can filter on certificates such as GMP, FDA, CEP, Written Confirmation and more. Send inquiries for free and get in direct contact with the supplier of your choice.
- API | Excipient name:
- Eptinezumab
- Synonyms:
- Cas Number:
- 1644539-04-7
- DrugBank number:
- DB14040
- Unique Ingredient Identifier:
- 8202AY8I7H
General Description:
Eptinezumab, identified by CAS number 1644539-04-7, is a notable compound with significant therapeutic applications. Eptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals. Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP). It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.
Indications:
This drug is primarily indicated for: Eptinezumab is indicated for the preventive treatment of migraine in adults. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.
Metabolism:
Eptinezumab undergoes metabolic processing primarily in: Monoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.
Absorption:
The absorption characteristics of Eptinezumab are crucial for its therapeutic efficacy: Eptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP . With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion . The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively . The drug's ability to rapidly penetrate into cells ensures quick onset of action.
Half-life:
The half-life of Eptinezumab is an important consideration for its dosing schedule: The plasma half-life after an intravenous infusion is approximately 27 days. This determines the duration of action and helps in formulating effective dosing regimens.
Protein Binding:
Eptinezumab exhibits a strong affinity for binding with plasma proteins: Readily accessible data regarding the protein binding of eptinezumab is not available. This property plays a key role in the drug's pharmacokinetics and distribution within the body.
Route of Elimination:
The elimination of Eptinezumab from the body primarily occurs through: Monoclonal antibody agents like eptinezumab are generally not eliminated via hepatic, renal, or biliary routes. Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.
Volume of Distribution:
Eptinezumab is distributed throughout the body with a volume of distribution of: The central volume of distribution for eptinezumab is approximately 3.7 L. This metric indicates how extensively the drug permeates into body tissues.
Clearance:
The clearance rate of Eptinezumab is a critical factor in determining its safe and effective dosage: The apparent clearance of eptinezumab is 0.006 L/h. It reflects the efficiency with which the drug is removed from the systemic circulation.
Pharmacodynamics:
Eptinezumab exerts its therapeutic effects through: Eptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection . During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm. Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007). Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.
Mechanism of Action:
Eptinezumab functions by: Eptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP). Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy. Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients. For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.
Toxicity:
Classification:
Eptinezumab belongs to the None, classified under the direct parent group Peptides. This compound is a part of the Organic Compounds, falling under the Organic Acids superclass, and categorized within the Carboxylic Acids and Derivatives class, specifically within the Amino Acids, Peptides, and Analogues subclass.
Categories:
Eptinezumab is categorized under the following therapeutic classes: Amino Acids, Peptides, and Proteins, Analgesics, Antibodies, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antimigraine Preparations, Blood Proteins, Calcitonin Gene-Related Peptide (CGRP) Antagonists, Calcitonin Gene-related Peptide Antagonist, Globulins, Immunoglobulins, Immunoproteins, Nervous System, Proteins, Serum Globulins. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.
Experimental Properties:
Further physical and chemical characteristics of Eptinezumab include:
- Molecular Weight: 143000.0
Eptinezumab is a type of Analgesics
Analgesics are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that are commonly used to relieve pain. They are designed to alleviate discomfort by targeting the body's pain receptors or by reducing inflammation. Analgesics are widely utilized in the medical field to manage various types of pain, ranging from mild to severe.
One of the primary classes of analgesics is nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by inhibiting the production of prostaglandins, substances that contribute to pain and inflammation. This class includes well-known drugs like ibuprofen and naproxen. Another class of analgesics is opioids, which are derived from opium or synthetic compounds that mimic the effects of opium. Opioids act on the central nervous system to reduce pain perception and provide potent pain relief. Examples of opioids include morphine, codeine, and oxycodone.
Analgesics are available in various forms, such as tablets, capsules, creams, and injections, allowing for different routes of administration based on the patient's needs. They are commonly used to manage pain associated with conditions like arthritis, headaches, dental procedures, and post-operative recovery.
It is important to note that analgesics should be used under medical supervision, as improper use or overuse can lead to adverse effects, including gastrointestinal complications, addiction, and respiratory depression in the case of opioids. Therefore, it is crucial for healthcare professionals to assess each patient's individual needs and prescribe the appropriate analgesic and dosage.
In summary, analgesics are a vital category of pharmaceutical APIs used to alleviate pain by targeting pain receptors or reducing inflammation. With various classes and forms available, they provide valuable options for pain management when used responsibly and under medical guidance.
