Vilobelimab

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.

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)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)	2024/11/25	NCT06703073	Phase 2	Recruiting	PPD Development, LP
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab	2024/11/22	NCT06701682	Phase 2	Recruiting	PPD Development, LP
Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum	2023/07/27	NCT05964413	Phase 3	Recruiting	InflaRx GmbH
Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.	2021/03/23	NCT04812535	Phase 2	Terminated	InflaRx GmbH
Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia	2020/04/03	NCT04333420	Phase 2	Completed	InflaRx GmbH
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum	2019/06/03	NCT03971643	Phase 2	Completed	InflaRx GmbH
Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.	2019/03/29	NCT03895801	Phase 2	Completed	InflaRx GmbH
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA	2018/10/19	NCT03712345	Phase 2	Terminated	InflaRx GmbH
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)	2018/04/04	NCT03487276	Phase 2	Completed	InflaRx GmbH

FDA Drug Approvals

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

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Gohibic	InflaRx GmbH,Winzerlaer Strasse 2,Ammerbach,07745 Jena,GERMANY	Authorised	1/13/2025

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	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

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

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