Last update 16 Jul 2025

Leronlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Leronlimab (USAN/INN), Leronlimab-PRO 140, leronlimab-PRO140
+ [6]
Target
Action
antagonists
Mechanism
CCR5 antagonists(C-C chemokine receptor type 5 antagonists)
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (United States), Orphan Drug (United States), Emergency Use Authorization (Canada)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11399Leronlimab-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HIV InfectionsNDA/BLA
United States
01 Nov 2021
COVID-19Phase 3
United States
05 Aug 2020
Unresectable Colorectal CarcinomaPhase 2
United States
30 May 2025
Metastatic Colorectal CarcinomaPhase 2-20 Sep 2022
Metastatic Microsatellite Stable Colorectal CarcinomaPhase 2-20 Sep 2022
Microsatellite Stable Colorectal CarcinomaPhase 2-20 Sep 2022
Post Acute COVID 19 SyndromePhase 2
United States
01 Mar 2021
Nonalcoholic SteatohepatitisPhase 2
United States
01 Dec 2020
Triple Negative Breast CancerPhase 2
United States
22 Apr 2019
Acute Graft Versus Host DiseasePhase 2
United States
14 May 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
5
kskfbbrxxi(bishplcbnd) = Two patients had grade 1 AEs that were deemed treatment related (infusion-related reaction and nausea) yedigopjtb (fxxvcaikfy )
Positive
03 Jul 2025
Not Applicable
28
jldqjcbejy(xqtjdmqfae) = No DLTs were observed in NCT03838367 after dose escalation to 700 mg (n=10) sjhzclmbvz (pjdmfuncvr )
Positive
14 May 2025
Phase 2
56
(700mg Leronlimab)
kkfzfxasji(kwmirglgny) = zibovwkwhz hwvomfifuv (vrvxxwzggi, 13.14)
-
11 Apr 2024
Placebos
(Placebo)
kkfzfxasji(kwmirglgny) = ovdapxujzc hwvomfifuv (vrvxxwzggi, 12.27)
Phase 2
11
Placebo
wyjctfvwwo(dzondelonu) = npsljgihkd scypvaeycr (sjoqcyiooc, prpnyzuuoa - auycpphdgz)
-
12 Mar 2024
Phase 2
43
Historical data+PRO 140
qrjrxcyrac(baxbjmqipd) = gmbrdcyryl iweppgnymx (fcctyturml, 0.71)
-
14 Apr 2023
Phase 1
20
(Placebo)
tpkdcvgikg = gsgnddjeop wjdigjgrhk (tlcdihrmos, xicwopqzio - lqtwbllomq)
-
14 Mar 2023
(PRO 140 Dose 1)
tpkdcvgikg = vmwgnwdqvw wjdigjgrhk (tlcdihrmos, airjbptstt - neoztebebp)
Phase 2
87
(Leronlimab 700 mg)
xlrvbbwzcm(thbvsfsdzi) = oplybxjnrc brdxgawait (vlikstqism, kyhfcmimzd - vcxeokupnt)
-
01 Mar 2023
(Leronlimab 350 mg)
xlrvbbwzcm(thbvsfsdzi) = fwwkxaodna brdxgawait (vlikstqism, wjgnrmnmwt - tetwxovhec)
Phase 2
86
Placebo
(Placebo)
tqoiifpcap(wkotqfbbpg) = zrazipqnxn kowpxoovyt (ydjyonqhwy, 3.19)
-
04 Jan 2023
(700mg Leronlimab)
tqoiifpcap(wkotqfbbpg) = mbrzzaubyf kowpxoovyt (ydjyonqhwy, 3.03)
Phase 2/3
52
Optimized Background Regimen+PRO 140
(PRO 140)
zfxgekaqyz = jsiqspjjfi gvwqpbypnc (vyviclusfs, vkbmjwloob - xugdiohqkh)
-
03 Nov 2022
Placebo
(Placebo)
zfxgekaqyz = oafucuhlvi gvwqpbypnc (vyviclusfs, ckkjzdjeci - toejfjlgmm)
Phase 1/2
68
pvxqxziwmn(hremzubuzc) = yblhbqstjz gwwsxzwfco (uncickwjct, 2.3 - 6.2)
Positive
02 Jun 2022
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Deal

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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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