Identification
- Generic Name
- Etesevimab
- DrugBank Accession Number
- DB15897
- Background
Etesevimab (LY-CoV016, also known as JS016) is a fully human and recombinant monoclonal antibody that targets the SARS-CoV-2 surface spike protein receptor binding domain.1,2 Under the EUA granted in February 2021, etesevimab is used in combination with bamlanivimab to treat mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19:4 this EUA later expanded in December 2021 to include all younger children at high risk, including newborns.3 The EUA currently allows bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19 in adults and children.4
- Type
- Biotech
- Groups
- Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Etesevimab
- External IDs
- CB6
- JS016
- LY-3832479
- LY-CoV016
- LY3832479
- NP005
- WHO 11873
Pharmacology
- Indication
Etesevimab in combination with bamlanivimab is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, 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. This combination regimen is also used for post-exposure prophylaxis of COVID-19 in unvaccinated or immunocompromised adults and pediatric individuals, including neonates, who are at high risk of progression to severe COVID-19, including hospitalization or death.5
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 Used in combination to treat Mild to moderate covid-19 Regimen in combination with: Bamlanivimab (DB15718) •••••••••••• ••••••••• •••• •• ••••••••••• •• •••••• •••••••• Used in combination for prophylaxis of Mild to moderate covid-19 Regimen in combination with: Bamlanivimab (DB15718) •••••••••••• •••••••••••••••••• ••••••••••••••••• ••••••••• •••• •• ••••••••••• •• •••••• •••••••• - 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
Not Available
- Mechanism of action
Etesevimab aims to neutralize SARS-CoV-2 by specifically binding to the virus' surface spike protein receptor binding domain. This high affinity binding then prevents SARS-CoV-2 from binding to the ACE2 host cell surface receptor. Etesevimab is currently being investigated against COVID-19.
Target Actions Organism ASpike glycoprotein binderSARS-CoV-2 - Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Not Available
- 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.Not Available
- Food Interactions
- Not Available
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 Etesevimab Injection, solution 35 mg/1mL Intravenous Eli Lilly and Company 2021-02-09 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
- N7Q9NLF11I
- CAS number
- 2423948-94-9
References
- General References
- Lilly Investors: Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs [Link]
- Junshi Biosciences: Junshi Biosciences Announces Completion of Enrollment in Phase I Trial of JS016 [Link]
- FDA Press Announcements: FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns [Link]
- Emergency Use Authorization (EUA) Letter of Authorization (January 24, 2022): Bamlanivimab and Etesevimab [Link]
- FDA: Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bamlanivimab and Etesevimab [Link]
- External Links
- 2477854
- Wikipedia
- Bamlanivimab/etesevimab
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Terminated Other Coronavirus Disease 2019 (COVID‑19) 1 3 Completed Prevention Coronavirus Disease 2019 (COVID‑19) 1 3 Terminated Treatment Coronavirus Disease 2019 (COVID‑19) 1 2 Completed Treatment Coronavirus Disease 2019 (COVID‑19) 1 2 Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, solution Intravenous 35 mg/1mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- 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. 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
Drug created at October 07, 2020 16:21 / Updated at April 01, 2022 19:23