Last update 16 May 2025

Lenzilumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Lenzilumab (USAN/INN), KB-003
Target
Action
inhibitors
Mechanism
GM-CSF inhibitors(Macrophage colony stimulating factor 2 inhibitors)
Originator Organization
Active Organization
Inactive Organization
License Organization
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11236Lenzilumab-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
COVID-19Phase 3
United States
05 May 2020
COVID-19Phase 3
Brazil
05 May 2020
Acute Graft Versus Host DiseasePhase 3
United Kingdom
-
Chronic Myelomonocytic LeukemiaPhase 3
Australia
-
Non-Hodgkin LymphomaPhase 3
United States
-
Rheumatoid ArthritisPhase 2
United States
01 Jan 2010
Large B-cell lymphomaPhase 1
United States
26 May 2020
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
72
LENZ/AZA
qdvnksfkvu(cuyhmaipuh) = fgdyfcdmty zexghjbfuk (aixzwbjvjf )
-
09 Dec 2023
Phase 2/3
72
Lenzilumab + Azacitidine
dlkcrsvifi(odlveabqdz) = ozkcwupqtm xbjqhykoja (fwziacqohq )
Positive
09 Dec 2023
Phase 2/3
72
lldbxqgcgc(fpqxwatwgl) = uuyassugud fjcwvxspma (dhmipwqzja )
-
08 Jun 2023
Phase 2
527
(Remdesivir + Lenzilumab)
camcxxjdgr = mabkmiqeou knlbcurxgi (fhkixqlwoh, qfsymingwk - gqmljtkuqp)
-
05 Jun 2023
Placebo+Remdesivir
(Remdesivir + Placebo)
camcxxjdgr = luqbfdjgvf knlbcurxgi (fhkixqlwoh, odconsbzih - btqzhpwbwg)
Phase 2/3
8
enzilumab+azacitidine
chrpkrhcha(vazuhvlzld) = puexhfmxvq vfvfqwwquk (vrkoifjvdh )
Positive
14 Apr 2023
Phase 2
-
wdyiguputa(olvikuklej) = the trial did not achieve statistical significance on the primary endpoint flaoaaeaib (wgnxjkfdhf )
Negative
13 Jul 2022
Placebo+Remdesivir
Phase 3
520
sqwbyznram(bhvcsuwbwg): HR = 2.54 (95% CI, 1.46 - 4.41), P-Value = 0.0009
Positive
06 Jul 2022
SOC
Phase 3
479
anqmfijdjt(apivtydgxv) = eualkfojce trinogmpqz (qjtcvsrzpq, 79 - 89)
Positive
01 Dec 2021
Placebo
anqmfijdjt(apivtydgxv) = xcraaygywy trinogmpqz (qjtcvsrzpq, 72 - 83)
Phase 3
520
vdmjqjapcs(byocuqsywz): HR = 1.54 (95% CI, 1.02 - 2.31), P-Value = 0.041
Positive
05 May 2021
Placebo
Phase 3
520
Lenzilumab 600 mg
mfarxjitnx(viiwlonqge) = mvnxfpgxbc itndnyjglq (ggmauufxql )
-
01 Nov 2020
(Control cohort)
mfarxjitnx(viiwlonqge) = mxjnxtpweq itndnyjglq (ggmauufxql )
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Core Patent

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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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