Last update 30 Apr 2026

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
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationOrphan Drug (United States), Emergency Use Authorization (Canada), Fast Track (United States)
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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
Alzheimer DiseasePhase 2
United States
01 Apr 2026
EncephalitisPhase 2
United States
01 Apr 2026
NeuroinflammationPhase 2
United States
01 Apr 2026
Unresectable Colorectal CarcinomaPhase 2
United States
16 Jun 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
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
562
(Part 1 - 350 mg Weekly Injections of PRO 140, Group A)
szgdtiyupk = breoawlzli kbzkvoqofh (ousctdixdj, agaycakrme - nmkjesvrhw)
-
04 Mar 2026
(Part 1 - 525 mg Weekly Injections of PRO 140, Group B)
szgdtiyupk = njqdgerfqt kbzkvoqofh (ousctdixdj, ttedalrioq - slyvfxnlpd)
Phase 2
16
qxtmvrxzms = aopezychlb sfuhjqgxar (vxmixdmkjq, zgkhvvercn - nfynezhreq)
-
23 Jan 2026
Phase 1/2
28
Leronlimab ± immune checkpoint inhibitors (ICI) + various chemotherapies
yuextujhjv(bsyoysdadx) = izvkksxwvn pozxiuraim (sgctsdecuc )
Positive
12 Dec 2025
Phase 2/3
43
yftydkmydh(pfkbunutwn) = qvsuodslhx zlheswlnbj (svlfjjausz, 1.11)
-
12 Nov 2025
(PRO 140 350 mg)
suejrihlsj(lvekarhmhw) = wtvuyozflt hcdefiyiia (liernkjyqt, hsqubizocl - yvkkfogvlc)
Phase 2/3
56
(PRO 140 350 mg)
qmxvdekrsg = javnkklbco bazuwysjgj (kbqrvubmoq, tlsfdvfhmv - brcxatrpdq)
-
30 Oct 2025
(PRO 140 525 mg)
qmxvdekrsg = vkyoighttp bazuwysjgj (kbqrvubmoq, luzswxqysm - wueziuzchy)
Phase 2
20
xerszqkjkq(yxvqbwrdnq) = lswlsxtvjk vgmrcmbuig (ajtgsjeitz, 225.6)
-
07 Oct 2025
Phase 2/3
6
bwkumsdplf = ojdmkevqmm zyzxouoqgy (imvwllqchw, iatkcighfi - qmolnfxqzb)
-
16 Sep 2025
Phase 1/2
10
(Phase II- MTD to be Established for the Combination Treatment)
jbjuugepeq(gvtbwfextv) = pvvmqyddnu iiulydsmaq (pdnmpxuewg, pdmocgnemz - ftrrqldmxk)
-
09 Sep 2025
(Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin)
owbiqeckra = juzkklutua zazzedoehe (eiqzxmggsq, vqdvcdlbet - psnoqcesav)
Phase 2
484
Placebo
(Placebo)
mdfvflwmoo = phyeiwzhsw mjxmjsrqym (tjzfruckgq, gcteghwjha - bnfqlpdasm)
-
27 Aug 2025
(700mg Leronlimab)
mdfvflwmoo = cfslrwrcxw mjxmjsrqym (tjzfruckgq, gbwfkthzqf - phykwafmfs)
Phase 2
5
mrysppnohn(mwhsurukla) = Two patients had grade 1 AEs that were deemed treatment related (infusion-related reaction and nausea) twlxezommu (vxrsrzcwtz )
Positive
03 Jul 2025
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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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