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 with the ability to neutralize the SARS-CoV-2 virus.7 On May 26, 2021 the FDA granted GlaxoSmithKline and Vir Biotechnology emergency use authorization for sotrovimab in the treatment of mild-to-moderate COVID-19. This authorization was based on interim results from a clinical trial, demonstrating that treatment with sotrovimab resulted in an 85% reduction in the risk of death or hospitalization in high-risk adults with COVID-19 in the outpatient setting.5,7 A fact sheet for healthcare providers is currently available.6
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
Sotrovimab is authorized for use under FDA's Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.5
In the EU, 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
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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- 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 USpike 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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- 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. 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. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Sotrovimab. Amivantamab The risk or severity of adverse effects can be increased when Sotrovimab is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Anifrolumab is combined with Sotrovimab. Ansuvimab The risk or severity of adverse effects can be increased when Sotrovimab is combined with Ansuvimab. Anthrax immune globulin human The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Sotrovimab. Antilymphocyte immunoglobulin (horse) The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Sotrovimab. 
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- 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 LLC 2021-05-26 Not applicable US 
Sotrovimab for Injection Solution 500 mg / 8 mL Intravenous Glaxosmithkline Inc 2021-10-08 Not applicable Canada 
- 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 LLC 2021-05-26 Not applicable US
Categories
- Drug Categories
- 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]
- External Links
- 2550731
- Wikipedia
- Sotrovimab
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Suspended Treatment Coronavirus Disease 2019 (COVID‑19) / Hospital Acquired Infections 1 3 Active Not Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 3 Recruiting Other Coronavirus Disease 2019 (COVID‑19) 1 3 Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 2 Active Not Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 2 Completed Treatment Coronavirus Disease 2019 (COVID‑19) 1 2 Not Yet Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 2, 3 Completed Treatment Coronavirus Disease 2019 (COVID‑19) 1 1 Completed Other Coronavirus Disease 2019 (COVID‑19) 1 1 Not Yet Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) / Covid 19 Infection / Hematopoietic and Lymphoid Cell Neoplasm / Malignant Solid Neoplasms 1
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 - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- SARS-CoV-2
- Pharmacological action
- Unknown
- Actions
- Binder
- General Function
- Spike protein S1 attaches the virion to the cell membrane by interacting with host receptor, initiating the infection. Binding to human ACE2 receptor and internalization of the virus into the endosomes of the host cell induces conformational changes in the Spike glycoprotein (PubMed:32142651, PubMed:32075877, PubMed:32155444). Uses also human TMPRSS2 for priming in human lung cells which is an essential step for viral entry (PubMed:32142651). Can be alternatively processed by host furin (PubMed:32362314). Proteolysis by cathepsin CTSL may unmask the fusion peptide of S2 and activate membranes fusion within endosomes.
- 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 January 16, 2022 18:54