This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.

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

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Associated Conditions
Contraindications & Blackbox Warnings
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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.

TargetActionsOrganism
ASpike glycoprotein
binder
SARS-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
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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

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
EtesevimabInjection, solution35 mg/1mLIntravenousEli Lilly and Company2021-02-09Not applicableUS flag

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
  1. Lilly Investors: Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs [Link]
  2. Junshi Biosciences: Junshi Biosciences Announces Completion of Enrollment in Phase I Trial of JS016 [Link]
  3. 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]
  4. Emergency Use Authorization (EUA) Letter of Authorization (January 24, 2022): Bamlanivimab and Etesevimab [Link]
  5. FDA: Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bamlanivimab and Etesevimab [Link]
RxNav
2477854
Wikipedia
Bamlanivimab/etesevimab

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4RecruitingOtherCoronavirus Disease 2019 (COVID‑19)1
3CompletedPreventionCoronavirus Disease 2019 (COVID‑19)1
3TerminatedTreatmentCoronavirus Disease 2019 (COVID‑19)1
2CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)1
2RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1
2, 3CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)1
1CompletedBasic ScienceHealthy Subjects (HS)2
1RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19) / COVID-19; and High Infection Risk of SARS-CoV-21
Not AvailableRecruitingNot AvailableCoronavirus Disease 2019 (COVID‑19)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solutionIntravenous35 mg/1mL
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Targets

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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
  1. Lilly Investors: Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs [Link]
  2. Junshi Biosciences: Junshi Biosciences Announces Completion of Enrollment in Phase I Trial of JS016 [Link]

Drug created at October 07, 2020 16:21 / Updated at April 01, 2022 19:23