Sotrovimab
Explore a selection of our essential drug information below, or:
Overview
- Description
- A medication used to treat people who are at a higher risk of death or hospitalization due to COVID-19.
- Description
- A medication used to treat people who are at a higher risk of death or hospitalization due to COVID-19.
- DrugBank ID
- DB16355
- Type
- Biotech
- Clinical Trials
- Phase 0
- 0
- Phase 1
- 11
- Phase 2
- 10
- Phase 3
- 14
- Phase 4
- 3
- Mechanism of Action
Identification
- Summary
Sotrovimab is a monoclonal antibody for the treatment of mild-to-moderate COVID-19 in patients at increased risk for death or hospitalization.
- Generic Name
- Sotrovimab
- DrugBank Accession Number
- DB16355
- Background
Sotrovimab (VIR-7831), also known as GSK4182136, is a monoclonal antibody that can neutralize the SARS-CoV-2 virus.7 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.5,6,7 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.11
Sotrovimab was granted marketing authorization in the European Union in December 2021 under the brand name Xevudy.9,10
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Chemical Formula
- Not Available
- Protein Average Weight
- 149000.0 Da
- Sequences
- Not Available
- Synonyms
- Sotrovimab
- External IDs
- GSK-4182136
- GSK4182136
- VIR-7831
- VIR7831
Pharmacology
- Indication
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.10
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Coronavirus disease 2019 (covid‑19) •••••••••••• •••••• •• •• •• ••••• •••• •••• •• ••••••••••• •• •••••• •••••••• •••••• ••••••••••••••• •••••••••• ••••••••• ••••••••••• - Contraindications & Blackbox Warnings
- Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API
- Pharmacodynamics
Sotrovimab is a monoclonal antibody that treats mild-to-moderate COVID-19 by binding to and neutralizing the spike protein of SARS-CoV-2.3,7
- Mechanism of action
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.4 This prevents the spike protein mediated binding of SARS-CoV-2 and entry into human cells.2 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.6
Target Actions Organism ASpike glycoprotein binderSARS-CoV-2 - Absorption
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.6
- Volume of distribution
Sotrovimab is an Fc-enhanced human immunoglobulin G (IgG), and therefore has the potential for placental transfer.6
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
This antibody has undergone modifications for a potentially extended half-life and enhanced lung bioavailability.4 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.6
- Clearance
Not Available
- Adverse Effects
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- Toxicity
There are currently no data available regarding an overdose with sotrovimab, and LD50 information is not available. If an overdose occurs, provide symptomatic and supportive treatment as required.6
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Sotrovimab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Sotrovimab. Adenovirus type 7 vaccine live The therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Sotrovimab. Aducanumab The risk or severity of adverse effects can be increased when Aducanumab is combined with Sotrovimab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Sotrovimab. - Food Interactions
- No interactions found.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Sotrovimab Injection, solution, concentrate 62.5 mg/1mL Intravenous Glaxosmithkline Inc 2021-05-26 Not applicable US Sotrovimab for Injection Solution 500 mg / 8 mL Intravenous Glaxosmithkline Inc 2021-10-08 Not applicable Canada Xevudy Injection, solution, concentrate 500 mg/8ml Intravenous Glaxo Smith Kline Trading Services 2022-01-21 Not applicable EU - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Sotrovimab Sotrovimab (62.5 mg/1mL) Injection, solution, concentrate Intravenous Glaxosmithkline Inc 2021-05-26 Not applicable US
Categories
- ATC Codes
- J06BD05 — Sotrovimab
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Anti-Infective Agents
- Antibodies
- Antibodies, Monoclonal
- Antiinfectives for Systemic Use
- Antiviral Agents
- Antiviral monoclonal antibodies
- Approved Treatments for COVID-19
- Blood Proteins
- Experimental Unapproved Treatments for COVID-19
- Globulins
- Immune Sera and Immunoglobulins
- Immunoglobulins
- Immunoproteins
- Proteins
- Serum Globulins
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- 1MTK0BPN8V
- CAS number
- 2423014-07-5
References
- General References
- Ning L, Abagna HB, Jiang Q, Liu S, Huang J: Development and application of therapeutic antibodies against COVID-19. Int J Biol Sci. 2021 Apr 10;17(6):1486-1496. doi: 10.7150/ijbs.59149. eCollection 2021. [Article]
- Tuccori M, Ferraro S, Convertino I, Cappello E, Valdiserra G, Blandizzi C, Maggi F, Focosi D: Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline. MAbs. 2020 Jan-Dec;12(1):1854149. doi: 10.1080/19420862.2020.1854149. [Article]
- Owji H, Negahdaripour M, Hajighahramani N: Immunotherapeutic approaches to curtail COVID-19. Int Immunopharmacol. 2020 Nov;88:106924. doi: 10.1016/j.intimp.2020.106924. Epub 2020 Aug 21. [Article]
- GSK: Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19 [Link]
- FDA Emergency Use Authorization Letter: Sotrovimab [Link]
- FDA: Sotrovimab fact sheet for healthcare providers [Link]
- GlaxoSmithKline: GSK and Vir Biotechnology announce sotrovimab (VIR-7831) receives Emergency Use Authorization from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients [Link]
- Clinicaltrials.gov: VIR-7831 for the Early Treatment of COVID-19 in Outpatients (COMET-ICE) [Link]
- BioSpace: Xevudy (Sotrovimab) Granted Marketing Authorization by the European Commission for the Early Treatment of COVID-19 [Link]
- EMA Summary of Product Characteristics: Xevudy (sotrovimab) concentrate for solution for infusion [Link]
- FDA Drug Safety and Availability: FDA updates Sotrovimab emergency use authorization [Link]
- External Links
- 2550731
- Wikipedia
- Sotrovimab
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available No Longer Available Not Available Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide Not Available Recruiting Not Available Coronavirus Disease 2019 (COVID‑19) 2 somestatus stop reason just information to hide Not Available Unknown Status Not Available Coronavirus Disease 2019 (COVID‑19) 2 somestatus stop reason just information to hide 4 Completed Treatment Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide 4 Terminated Other Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, solution, concentrate Intravenous 62.5 mg/1mL Solution Intravenous 500 mg / 8 mL Injection, solution, concentrate Intravenous 500 mg/8ml - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- SARS-CoV-2
- Pharmacological action
- Yes
- Actions
- Binder
- General Function
- Spike protein S1 Attaches the virion to the cell membrane by interacting with host receptor, initiating the infection. The major receptor is host ACE2 (PubMed:32142651, PubMed:32155444, PubMed:33607086). When S2/S2' has been cleaved, binding to the receptor triggers direct fusion at the cell membrane (PubMed:34561887). When S2/S2' has not been cleaved, binding to the receptor results in internalization of the virus by endocytosis leading to fusion of the virion membrane with the host endosomal membrane (PubMed:32075877, PubMed:32221306). Alternatively, may use NRP1/NRP2 (PubMed:33082294, PubMed:33082293) and integrin as entry receptors (PubMed:35150743). The use of NRP1/NRP2 receptors may explain the tropism of the virus in human olfactory epithelial cells, which express these molecules at high levels but ACE2 at low levels (PubMed:33082293). The stalk domain of S contains three hinges, giving the head unexpected orientational freedom (PubMed:32817270).
- Specific Function
- host cell surface receptor binding
- Gene Name
- S
- Uniprot ID
- P0DTC2
- Uniprot Name
- Spike glycoprotein
- Molecular Weight
- 141177.29 Da
References
- Tuccori M, Ferraro S, Convertino I, Cappello E, Valdiserra G, Blandizzi C, Maggi F, Focosi D: Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline. MAbs. 2020 Jan-Dec;12(1):1854149. doi: 10.1080/19420862.2020.1854149. [Article]
- GlaxoSmithKline: GSK and Vir Biotechnology announce sotrovimab (VIR-7831) receives Emergency Use Authorization from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients [Link]
Drug created at December 16, 2020 17:22 / Updated at October 11, 2024 22:08