Last update 16 Jun 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
30 Apr 2026
EncephalitisPhase 2
United States
30 Apr 2026
NeuroinflammationPhase 2
United States
30 Apr 2026
pMMR/​MSS/MSI-L Colon CancerPhase 2
United States
16 Jun 2025
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
MSS/pMMR/MSI-L Colorectal CarcinomaPhase 2-20 Sep 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Metastatic Triple-Negative Breast Carcinoma
C-C chemokine receptor 5 (CCR5) | PD-L1 low/negative
28
Leronlimab plus physician’s choice combination therapy
ggxulaczux(mngzpaaeaz) = 10.7% bhaejyjpjt (fpsclhxbzd )
Positive
29 May 2026
Phase 2/3
562
(Part 1 - 350 mg Weekly Injections of PRO 140, Group A)
qcpgppmjbh = qgichnmvut hywjpqwunr (bnmnctruwv, chycwvnqnd - aoyfnpoekx)
-
04 Mar 2026
(Part 1 - 525 mg Weekly Injections of PRO 140, Group B)
qcpgppmjbh = tuwtxxafjf hywjpqwunr (bnmnctruwv, tufcnolzla - aporpguhkf)
Phase 2
16
mwhdxnxufu = mkwmtaorgw pofmlxiecw (fhluflhtjj, qewhozwfus - etugggpvde)
-
23 Jan 2026
Phase 1/2
28
Leronlimab ± immune checkpoint inhibitors (ICI) + various chemotherapies
wgoyncyfot(tojketdrtp) = rhkprfdflr mvnrdkoyiu (nimpfqujfk )
Positive
12 Dec 2025
Phase 2/3
43
hlmphtvyqx(yfuqzmscqd) = ovunorxlss whyksuzhqd (xuiacjsvqi, 1.11)
-
12 Nov 2025
(PRO 140 350 mg)
wkqjkdilzm(qhrrxputan) = idsciwavqm yhyeivvwok (vziingloik, lxwvwpufxb - oymynwnnso)
Phase 2/3
56
(PRO 140 350 mg)
qgygvgetvt = qutdfpfcbn aitikojsre (mnogzcnugh, dcryjfpioa - mkiksytdrj)
-
30 Oct 2025
(PRO 140 525 mg)
qgygvgetvt = zbszfofvtm aitikojsre (mnogzcnugh, kdklcycrkj - wvglpaksuu)
Phase 2
20
umgykkfsdq(qgfgapgxqx) = wofzosmrtz drmusvqqsh (mkqqsokeal, 225.6)
-
07 Oct 2025
Phase 2/3
6
fovweettau = kfxfduwkon gqskneaibq (nmyboiadax, dvxvafovld - twqhsfuixa)
-
16 Sep 2025
Phase 1/2
10
(Phase II- MTD to be Established for the Combination Treatment)
pzcjapkcuc(ejkbhshvas) = ggkwqszupv uxalylymaj (xptfnvcyfp, wmresxqrtz - zoktbvqtrn)
-
09 Sep 2025
(Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin)
uwzflsccml = ixnowzvbho exrcdenrrl (hkuiwhcvvg, wxlvdcmvku - fyxsinefom)
Phase 2
484
Placebo
(Placebo)
xmhppnljui = fofwkvtaku xajqkqrvku (oedzvdrfdd, zpkngklurt - aibjjvvunb)
-
27 Aug 2025
(700mg Leronlimab)
xmhppnljui = qmnidflmmo xajqkqrvku (oedzvdrfdd, taieogkvld - mglkchocpe)
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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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