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Vilobelimab

Generic Name
Vilobelimab
Brand Names
Gohibic
Drug Type
Biotech
CAS Number
2250440-41-4
Unique Ingredient Identifier
F5T0RF9ZJA

Overview

Vilobelimab is a chimeric monoclonal immunoglobulin G4 (IgG4) antibody that binds to the soluble form of human C5a with high affinity. It consists of mouse anti-human complement factor 5a (C5a) monoclonal binding sites (variable regions of heavy and light chain regions) and human gamma 4 heavy chain and light kappa chain constant regions. In April 2023, the FDA issued an emergency use authorization (EUA) for vilobelimab for the treatment of COVID-19 in hospitalized adults requiring mechanical ventilation or artificial life support. The drug is not yet fully approved for this condition.

Background

Vilobelimab is a chimeric monoclonal immunoglobulin G4 (IgG4) antibody that binds to the soluble form of human C5a with high affinity. It consists of mouse anti-human complement factor 5a (C5a) monoclonal binding sites (variable regions of heavy and light chain regions) and human gamma 4 heavy chain and light kappa chain constant regions. In April 2023, the FDA issued an emergency use authorization (EUA) for vilobelimab for the treatment of COVID-19 in hospitalized adults requiring mechanical ventilation or artificial life support. The drug is not yet fully approved for this condition.

Indication

Vilobelimab is used for emergency use to treat coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). However, vilobelimab is not FDA-approved for this use.

Associated Conditions

  • Coronavirus Disease 2019 (COVID‑19)

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
InflaRx GmbH
83000-110
INTRAVENOUS
10 mg in 1 mL
5/16/2023

EMA Drug Approvals

HSA Drug Approvals

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Manufacturer
Approval Number
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Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
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Status
Registration Date
No TGA approvals found for this drug.
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