Leronlimab

Summary

Leronlimab (CHEMBL2109343) is a phase-3 clinical-stage antibody targeting CCR5; indicated across 8 conditions including severe acute respiratory syndrome and hiv infectious disease.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Targets: 1 (CCR5)
• Indications: 8 conditions
• Clinical trials: 22

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2109343
Name	Leronlimab
Type	Antibody
Max phase	3

Also known as: Leronlimab, PRO 140, PRO-140, PRO140, LERONLIMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
CCR5	CCR5	Binding		0.7%	P51681

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): CCR5.

Top Reactome pathways

19 total, by targets touching each:

Pathway	Targets	Genes
Cytokine Signaling in Immune system	1	CCR5
Signal Transduction	1	CCR5
HIV Life Cycle	1	CCR5
Early Phase of HIV Life Cycle	1	CCR5
HIV Infection	1	CCR5
Disease	1	CCR5
Immune System	1	CCR5
Binding and entry of HIV virion	1	CCR5
Signaling by GPCR	1	CCR5
Class A/1 (Rhodopsin-like receptors)	1	CCR5
Peptide ligand-binding receptors	1	CCR5
Chemokine receptors bind chemokines	1	CCR5
GPCR downstream signalling	1	CCR5
G alpha (i) signalling events	1	CCR5
Signaling by Interleukins	1	CCR5
GPCR ligand binding	1	CCR5
Infectious disease	1	CCR5
Interleukin-10 signaling	1	CCR5
Viral Infection Pathways	1	CCR5

Dominant GO biological processes

GO term	Targets
MAPK cascade	1
dendritic cell chemotaxis	1
calcium ion transport	1
apoptotic process	1
chemotaxis	1
inflammatory response	1
immune response	1
cellular defense response	1
cell surface receptor signaling pathway	1
G protein-coupled receptor signaling pathway	1
positive regulation of cytosolic calcium ion concentration	1
cell-cell signaling	1
release of sequestered calcium ion into cytosol by sarcoplasmic reticulum	1
calcium-mediated signaling	1
signaling	1

Indications & clinical

Indications

7 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
severe acute respiratory syndrome	3	MONDO:0005091	MONDO:0100096
HIV infectious disease	2	MONDO:0005109	EFO:0000764
graft versus host disease	2	MONDO:0013730	MONDO:0013730
neoplasm	2	MONDO:0005070	EFO:0000616
metabolic dysfunction-associated steatohepatitis	2	MONDO:0007027	EFO:1001249
colorectal neoplasm	2	MONDO:0005335	MONDO:0005575
breast neoplasm	1	MONDO:0021100	EFO:0003869

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 22.

Phase distribution

Phase	Trials
PHASE2	13
PHASE2/PHASE3	3
PHASE3	2
Not specified	2
PHASE1/PHASE2	1
PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02483078	PHASE2/PHASE3	COMPLETED	Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140
NCT02990858	PHASE2/PHASE3	TERMINATED	An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study
NCT03902522	PHASE2/PHASE3	COMPLETED	PRO 140 in Treatment-Experienced HIV-1 Subjects
NCT04901676	PHASE3	SUSPENDED	Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia
NCT04901689	PHASE3	SUSPENDED	Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation
NCT06699836	PHASE2	ACTIVE_NOT_RECRUITING	The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)
NCT07553338	PHASE2	RECRUITING	Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer’s Disease
NCT00613379	PHASE2	COMPLETED	PRO 140 by IV Administration in Adults With HIV-1 Infection
NCT01272258	PHASE2	WITHDRAWN	A Trial of Observed Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Injection Drug Users With Viral Rebound and Documented Poor Adherence
NCT02175680	PHASE2	COMPLETED	Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
NCT02257788	PHASE2	WITHDRAWN	PRO 140 for Human Immunodeficiency Virus Infection
NCT02438345	PHASE2	WITHDRAWN	PRO 140 for Human Immunodeficiency Virus
NCT02737306	PHASE2	TERMINATED	A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation
NCT03838367	PHASE1/PHASE2	TERMINATED	Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC
NCT04343651	PHASE2	COMPLETED	Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
NCT04347239	PHASE2	COMPLETED	Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19
NCT04504942	PHASE2	COMPLETED	Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors
NCT04521114	PHASE2	COMPLETED	Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis
NCT04678830	PHASE2	COMPLETED	Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With Long COVID-19
NCT00110591	PHASE1	COMPLETED	Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
NCT02759042	Not specified	NO_LONGER_AVAILABLE	An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study
NCT04313075	Not specified	NO_LONGER_AVAILABLE	A Compassionate Use Study of Leronlimab in Breast Cancer

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

14 molecules share ≥1 primary target. Top 14 by shared-target count:

Molecule	Source	Status	Shared targets
ABAMETAPIR	ChEMBL	Phase 4 (approved)	CCR5
DISULFIRAM	ChEMBL	Phase 4 (approved)	CCR5
MARAVIROC	ChEMBL	Phase 4 (approved)	CCR5
TERFENADINE	ChEMBL	Phase 4 (approved)	CCR5
APLAVIROC	ChEMBL	Phase 3	CCR5
CENICRIVIROC	ChEMBL	Phase 3	CCR5
VICRIVIROC	ChEMBL	Phase 3	CCR5
ANCRIVIROC	ChEMBL	Phase 2	CCR5
AZD5672	ChEMBL	Phase 2	CCR5
BMS-741672	ChEMBL	Phase 2	CCR5
BMS-813160	ChEMBL	Phase 2	CCR5
INCB-9471	ChEMBL	Phase 2	CCR5
JNJ-17166864 CATION	ChEMBL	Phase 2	CCR5
Mavorixafor	PubChem	Approved	CCR5