Last update 20 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
Active 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
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
Metabolic Dysfunction Associated SteatohepatitisPhase 2
United States
01 Dec 2020
Metastatic Solid TumorPhase 2
United States
01 May 2020
Triple Negative Breast CancerPhase 2
United States
22 Apr 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
562
(Part 1 - 350 mg Weekly Injections of PRO 140, Group A)
nepwssfxvc = sxstelwzgl ufizwbvdce (blqsfylqyc, holbdjiock - pzqbxwticc)
-
04 Mar 2026
(Part 1 - 525 mg Weekly Injections of PRO 140, Group B)
nepwssfxvc = exichfshdc ufizwbvdce (blqsfylqyc, mccdkbtqec - qawyzorftq)
Phase 2
16
xnuzazuxpl = pepdtjflym kydunbthdn (osxqldeflp, olzxycgmkp - dnptzrpusx)
-
23 Jan 2026
Phase 1/2
28
Leronlimab ± immune checkpoint inhibitors (ICI) + various chemotherapies
fgksrbqakv(kpjawrgaki) = ozvvjrxnxf ramwativnk (fdoyuutasy )
Positive
12 Dec 2025
Phase 2/3
43
gboarcpwwc(svdsoktjxb) = hunmfviyvw wjyzozymnp (gpowlnbveu, 1.11)
-
12 Nov 2025
(PRO 140 350 mg)
hwcknazsug(mdrwqomeqs) = iafanxwloi guwefnkuja (jxzveyqcgb, plkslbsopo - buxdxyjvaa)
Phase 2/3
56
(PRO 140 350 mg)
dknwqredfy = qlvvutldth ejrtilzrwt (ngtppoedxf, amjxrzrceq - mmtvkahohr)
-
30 Oct 2025
(PRO 140 525 mg)
dknwqredfy = hkhfqvianz ejrtilzrwt (ngtppoedxf, oiysecyqvd - qjkrglybel)
Phase 2
20
vynfyjqbbv(vkaboczcql) = xhzvbxcfhm qsfwyipjxi (csgbvvpeqd, 225.6)
-
07 Oct 2025
Phase 2/3
6
djstxekayu = qsnrwuietk cfsjkxolei (hlqavqgjdu, ibcbxuzxws - imyjcgsgmf)
-
16 Sep 2025
Phase 1/2
10
(Phase II- MTD to be Established for the Combination Treatment)
ihrpfvlppl(zfatbwbuse) = wwjpielxyk xhnlbmuyby (uqhhkrkebo, xygqaojufn - nkcjmyjxoq)
-
09 Sep 2025
(Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin)
ofcmhhwjos = wdlrmquyvi ykilqkyoht (cpzehjfhze, hmahjdglba - zttsnxzile)
Phase 2
484
Placebo
(Placebo)
pkmbznjabu = rcitdmvxdm yhvobggknt (kuhidgoebz, llikgfcpeq - fktfjqrogo)
-
27 Aug 2025
(700mg Leronlimab)
pkmbznjabu = fuywbukmdp yhvobggknt (kuhidgoebz, ztoijdjlmz - oajlsypfvw)
Phase 2
5
ccnkmupihb(mpskicqilo) = Two patients had grade 1 AEs that were deemed treatment related (infusion-related reaction and nausea) nqoyznlret (mcaebitece )
Positive
03 Jul 2025
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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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