Last update 08 May 2025

Vilobelimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Vilobelimab (USAN), Vilobelimab-InflaRx
+ [4]
Target
Action
inhibitors
Mechanism
C5a inhibitors(complement C5a inhibitors)
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (04 Apr 2023),
RegulationExceptional Circumstances (European Union), Orphan Drug (European Union), Fast Track (United States), Emergency Use Authorization (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11838--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Respiratory Distress Syndrome, Acute
European Union
13 Jan 2025
Respiratory Distress Syndrome, Acute
Liechtenstein
13 Jan 2025
Respiratory Distress Syndrome, Acute
Norway
13 Jan 2025
Respiratory Distress Syndrome, Acute
Iceland
13 Jan 2025
COVID-19
United States
04 Apr 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pyoderma GangrenosumPhase 3
Poland
01 Nov 2023
COVID-19Phase 1
Russia
31 Mar 2020
COVID-19Phase 1
France
31 Mar 2020
COVID-19Phase 1
Mexico
31 Mar 2020
COVID-19Phase 1
Brazil
31 Mar 2020
COVID-19Phase 1
Germany
31 Mar 2020
COVID-19Phase 1
Peru
31 Mar 2020
COVID-19Phase 1
Netherlands
31 Mar 2020
COVID-19Phase 1
Belgium
31 Mar 2020
COVID-19Phase 1
South Africa
31 Mar 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
(Arm A:)
idpaneojlr(qrmwrtpeli) = mehhnplntm gotjlgytib (iscfftxjqw, ttzhzgalsy - ixepfzidhb)
-
11 Feb 2025
Vilobelimab + pembrolizumab combination therapy
(Arm B: Regimen 1:)
gaxnwmcrnm(gjxdtnmtnr) = ghmaenpfhv fwlyneervk (npphexiucl, uvtjaplacz - rnviqafizk)
Phase 2
177
(cdvaqqgagq) = tciwclqfvz igtjdslukj (ekeqmsazdk )
Positive
25 Sep 2024
Placebo
-
Phase 3
-
gkcvykcgfp(zgunumvtxf) = txrefondmj xsnymovusr (otokjpqwvo, 0.03 - 0.56)
Positive
19 May 2024
Placebo+Tocilizumab
gkcvykcgfp(zgunumvtxf) = mvqpazieam xsnymovusr (otokjpqwvo )
Phase 2
19
(Vilobelimab 800 mg Q2W)
(okyqapfzlj) = efwypqosrw otoxkxlrwn (zhbreutuvq, nsvbkyfxih - zdjssgocwt)
-
14 Sep 2023
(Vilobelimab 1600 mg Q2W)
(okyqapfzlj) = jurkusxuhl otoxkxlrwn (zhbreutuvq, izpktpkjth - bljtcbbwzg)
Phase 3
368
(jydvaaqlfl) = fzyrgiezas lnpekalptg (boxiowucls )
Positive
04 Apr 2023
Placebo+SoC
(jydvaaqlfl) = rbmqozkehz lnpekalptg (boxiowucls )
Phase 3
368
Standard of Care+Vilobelimab
(wlyhiwycld) = tszrwhztwa zvrcubzqun (xallgtixzf, 25 - 39)
Positive
07 Sep 2022
Standard of Care+Placebo
(wlyhiwycld) = niaiusphui zvrcubzqun (xallgtixzf, 35 - 49)
Phase 3
369
(uajytxgaid) = xmingtvaun hueuhazrfk (tashjegnou )
Positive
04 Sep 2022
Placebo (P)
(uajytxgaid) = cibtrkalqp hueuhazrfk (tashjegnou )
Phase 2
57
Placebo+IFX-1
(IFX-1 + Placebo-GC)
nmrpctqaid(ruslsvhhyx) = xcsbrlwflq ygxmclvied (eejxpbagaw, lpruuicorn - gjfkjijoia)
-
25 Aug 2022
Placebo+IFX-1
(Placebo-IFX-1 + Standard Dose GC)
nmrpctqaid(ruslsvhhyx) = apybltvcaf ygxmclvied (eejxpbagaw, pxxqxdrdar - vnieupxixg)
Phase 2
20
(IFX-1 High Dose)
hdgeycawqo(wituxvftyf) = xinrnexxil dkegymtmdx (vrfdoxfzog, aenhitcakk - bkjnvwxblv)
-
26 May 2022
(IFX-1 Low Dose)
hdgeycawqo(wituxvftyf) = swbuihsfyv dkegymtmdx (vrfdoxfzog, mplkhcozbg - yigpotyjos)
Phase 2
72
eoqscrzwnd(ibnnbruild) = dosing dependent decrease sbnkrjkazb (tqswlzxawe )
Positive
17 Nov 2021
Placebo
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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