Sotrovimab API Manufacturers
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Looking for Sotrovimab API 2423014-07-5?
- Description:
- Here you will find a list of producers, manufacturers and distributors of Sotrovimab. 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:
- Sotrovimab
- Synonyms:
- Cas Number:
- 2423014-07-5
- DrugBank number:
- DB16355
- Unique Ingredient Identifier:
- 1MTK0BPN8V
General Description:
Sotrovimab, identified by CAS number 2423014-07-5, is a notable compound with significant therapeutic applications. Sotrovimab (VIR-7831), also known as GSK4182136, is a monoclonal antibody that can neutralize the SARS-CoV-2 virus. Sotrovimab was initially been granted emergency use authorization (EUA) to treat mild-to-moderate COVID-19 on May 26, 2021, based on interim results from a clinical trial, where sotrovimab was found to reduce the risk of death or hospitalization in high-risk adults with COVID-19 in the outpatient setting. However, in April 2022, the FDA removed the EUA for sotrovimab due to the rising COVID-19 cases caused by the Omicron BA.2 sub-variant, where the drug is ineffective. Sotrovimab was granted marketing authorization in the European Union in December 2021 under the brand name Xevudy.
Indications:
This drug is primarily indicated for: In Europe, sotrovimab is indicated for the treatment of COVID-19 in patients ≥12 years old and weighing ≥40kg who do not require supplemental oxygen and are at high risk of progressing to severe disease. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.
Absorption:
The absorption characteristics of Sotrovimab are crucial for its therapeutic efficacy: A non-compartmental analysis determined that the mean Cmax after a 1 hour IV infusion of sotrovimab was 137 µg/mL and the mean Day 29 concentration was 34 µg/mL. The drug's ability to rapidly penetrate into cells ensures quick onset of action.
Half-life:
The half-life of Sotrovimab is an important consideration for its dosing schedule: This antibody has undergone modifications for a potentially extended half-life and enhanced lung bioavailability. The half-life of sotrovimab is longer than Fc-unmodified IgG due to the LS modification, however, specific values are not available in the literature. This determines the duration of action and helps in formulating effective dosing regimens.
Volume of Distribution:
Sotrovimab is distributed throughout the body with a volume of distribution of: Sotrovimab is an Fc-enhanced human immunoglobulin G (IgG), and therefore has the potential for placental transfer. This metric indicates how extensively the drug permeates into body tissues.
Pharmacodynamics:
Sotrovimab exerts its therapeutic effects through: Sotrovimab is a monoclonal antibody that treats mild-to-moderate COVID-19 by binding to and neutralizing the spike protein of SARS-CoV-2. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.
Mechanism of Action:
Sotrovimab functions by: Sotrovimab is a recombinant human IgG1κ monoclonal antibody that acts by binding to a conserved epitope located on the spike protein receptor-binding domain of SARS-CoV-2, the virus causing COVID-19. The epitope is highly conserved, discouraging the development of viral resistance to the antibody. This prevents the spike protein mediated binding of SARS-CoV-2 and entry into human cells. Sotrovimab does not compete with human ACE2 receptor binding and inhibits an undefined step that occurs after viral attachment and before the fusion of the viral and cell membranes. The Fc component of sotrovimab includes M428L and N434S amino acid substitutions (LS modification) that result in a longer half-life. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.
Toxicity:
Classification:
Sotrovimab 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:
Sotrovimab is categorized under the following therapeutic classes: Amino Acids, Peptides, and Proteins, Antibodies, Antibodies, Monoclonal, Approved Treatments for COVID-19, Blood Proteins, Experimental Unapproved Treatments for COVID-19, Globulins, Immunoglobulins, Immunoproteins, 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 Sotrovimab include:
- Molecular Weight: 149000.0
Sotrovimab is a type of Other substances
The pharmaceutical industry encompasses a diverse range of active pharmaceutical ingredients (APIs) that are used in the production of various medications. One category of APIs is known as other substances. This category includes substances that do not fall under the conventional classifications such as antibiotics, analgesics, or antihypertensives.
Other substances in pharmaceutical APIs consist of a broad array of chemical compounds with unique properties and applications. These substances play a crucial role in the formulation and development of specialized medications, catering to specific therapeutic needs. The category encompasses various substances like excipients, solvents, stabilizers, and pH adjusters.
Excipients are inert substances that aid in the manufacturing process and enhance the stability, bioavailability, and patient acceptability of pharmaceutical formulations. Solvents are used to dissolve other ingredients and facilitate their incorporation into the final product. Stabilizers ensure the integrity and shelf life of medications by preventing degradation or chemical changes. pH adjusters help maintain the desired pH level of a formulation, which can influence the drug's efficacy and stability.
Pharmaceutical manufacturers carefully select and incorporate specific other substances into their formulations, adhering to regulatory guidelines and quality standards. These substances undergo rigorous testing and evaluation to ensure their safety, efficacy, and compatibility with the desired pharmaceutical product. By employing other substances in API formulations, pharmaceutical companies can optimize drug delivery, improve patient compliance, and enhance therapeutic outcomes.
In summary, the other substances category of pharmaceutical APIs comprises a diverse range of chemicals, including excipients, solvents, stabilizers, and pH adjusters. These substances contribute to the formulation, stability, and performance of medications, enabling pharmaceutical manufacturers to develop specialized products that meet specific therapeutic requirements.
