Regdanvimab API Manufacturers

General Description:

Regdanvimab, identified by CAS number 2444308-95-4, is a notable compound with significant therapeutic applications. Regdanvimab (CT-P59) is a recombinant human IgG1 monoclonal antibody directed at the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. It blocks the interaction between viral spike proteins and angiotensin-converting enzyme 2 (ACE2) that allows for viral entry into the cell, thereby inhibiting the virus' ability to replicate. Trials investigating the use of regdanvimab as a therapeutic candidate for the treatment of COVID-19 began in mid-2020. It received its first full approval in South Korea in September 2021, followed by the EU in November 2021.

Indications:

This drug is primarily indicated for: Regdanvimab is indicated in the EU for the treatment of adult patients with COVID-19 who do not require supplemental oxygen and who are at risk of progressing to severe COVID-19. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Regdanvimab undergoes metabolic processing primarily in: As regdanvimab is a recombinant IgG1 antibody, it is likely to be degraded into smaller peptides and amino acids in the same way as endogenous IgG1. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Regdanvimab are crucial for its therapeutic efficacy: The mean C_max and AUC_0-infof regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 were 1017 µg/mL and 182095 μg⋅h/ml, respectively. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Regdanvimab is an important consideration for its dosing schedule: The mean terminal half-life of regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 was 17 days. This determines the duration of action and helps in formulating effective dosing regimens.

Route of Elimination:

The elimination of Regdanvimab from the body primarily occurs through: Regdanvimab is likely to be eliminated via normal immunoglobulin degradation pathways. Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Volume of Distribution:

Regdanvimab is distributed throughout the body with a volume of distribution of: The steady-state apparent volume of distribution following intravenous administration of regdanvimab 40 mg/kg in patients with COVID-19 was 83 mL/kg. This metric indicates how extensively the drug permeates into body tissues.

Clearance:

The clearance rate of Regdanvimab is a critical factor in determining its safe and effective dosage: The mean clearance of regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 was 0.20 mL/hr/kg. It reflects the efficiency with which the drug is removed from the systemic circulation.

Pharmacodynamics:

Regdanvimab exerts its therapeutic effects through: Regdanvimab exerts its antiviral activity by blocking the viral entry of SARS-CoV-2. It should be given within seven days of the onset of COVID-19 symptoms, and is administered as a single intravenous infusion. Hypersensitivity reactions, including infusion-related reactions and anaphylaxis, have been reported during and after the intravenous administration of regdanvimab - patients should be observed during administration and for one hour after its completion to monitor for symptoms of infusion-related reactions such as fever, difficulty breathing, arrhythmia, and chills. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Regdanvimab functions by: Regdanvimab is a recombinant human IgG1 monoclonal antibody that is targeted at the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. The interaction between viral spike proteins and angiotensin-converting enzyme 2 (ACE2) receptors facilitates viral entry into host cells - in blocking this interaction, regdanvimab neutralizes SARS-CoV-2 by preventing cellular entry and subsequent viral replication. The binding interaction between regdanvimab and the spike protein RBD is different as compared to most other neutralizing antibodies, as it appears regdanvimab binds to the RBD protein trimer exclusively in its "up" conformation and in an orientation distinct from most other ACE2-blocking antibodies. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Classification:

Regdanvimab 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:

Regdanvimab is categorized under the following therapeutic classes: Amino Acids, Peptides, and Proteins, Antibodies, Antibodies, Monoclonal, Approved Treatments for COVID-19, Blood Proteins, Globulins, Immunoglobulin Isotypes, Immunoglobulins, Immunoproteins, Proteins, Serum Globulins. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.