Balixafortide

Summary

Balixafortide (CHEMBL4802129) is a phase-3 clinical-stage protein targeting CXCR4; indicated across 9 conditions including breast neoplasm and myocardial infarction.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Protein
• Targets: 1 (CXCR4)
• Indications: 9 conditions
• Clinical trials: 8
• Chemistry: 1864.1 Da · C84H118N24O21S2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4802129
Name	Balixafortide
Type	Protein
Max phase	3
FDA approved	no
PubChem CID	162677492
Molecular formula	C84H118N24O21S2
Molecular weight	1864.1
InChIKey	MKXOUIKTXREBLX-NDKBASPVSA-N

SMILES: C[C@H]1C(=O)N[C@H]2CSSC[C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N3CCC[C@@H]3C(=O)N4CCC[C@H]4C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)CC5=CNC=N5)CC6=CC=C(C=C6)O)CCCCN)CCC(=O)N)CC7=CC=C(C=C7)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@H]8CCCN8C(=O)[C@@H](NC(=O)[C@@H](NC2=O)CO)C)CCN)CCCNC(=N)N)CC9=CC=C(C=C9)O

IUPAC name: 3-[(1R,4S,7S,10S,16R,22S,25S,28S,31S,34R,37S,40S,46R,49S,52S,55S)-10-(4-aminobutyl)-49-(2-aminoethyl)-52-(3-carbamimidamidopropyl)-37-(hydroxymethyl)-4,25,55-tris[(4-hydroxyphenyl)methyl]-28-(1H-imidazol-4-ylmethyl)-31,40-dimethyl-2,5,8,11,17,23,26,29,32,35,38,41,47,50,53,56-hexadecaoxo-59,60-dithia-3,6,9,12,18,24,27,30,33,36,39,42,48,51,54,57-hexadecazapentacyclo[32.23.4.012,16.018,22.042,46]henhexacontan-7-yl]propanamide

Also known as: Balixafortida, Balixafortide, POL-6326, Pol6326, POL6326, BALIXAFORTIDE

Patent coverage: 144 distinct patent families (361 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

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
CXCR4	CXCR4	Antagonist		0%	P61073

Bioactivity

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

Target pathways

Aggregated over 1 target gene(s): CXCR4.

Top Reactome pathways

7 total, by targets touching each:

Pathway	Targets	Genes
Binding and entry of HIV virion	1	CXCR4
Signaling by ROBO receptors	1	CXCR4
Chemokine receptors bind chemokines	1	CXCR4
G alpha (i) signalling events	1	CXCR4
Formation of definitive endoderm	1	CXCR4
Specification of primordial germ cells	1	CXCR4
Developmental Lineage of Multipotent Pancreatic Progenitor Cells	1	CXCR4

Dominant GO biological processes

GO term	Targets
response to hypoxia	1
dendritic cell chemotaxis	1
apoptotic process	1
inflammatory response	1
immune response	1
G protein-coupled receptor signaling pathway	1
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathway	1
positive regulation of cytosolic calcium ion concentration	1
brain development	1
response to virus	1
calcium-mediated signaling	1
neurogenesis	1
regulation of cell adhesion	1
positive regulation of cell migration	1
CXCL12-activated CXCR4 signaling pathway	1

Indications & clinical

Indications

9 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
breast neoplasm	3	MONDO:0021100	MONDO:0007254
myocardial infarction	2	MONDO:0005068	EFO:0000612
plasma cell myeloma	2	MONDO:0009693	EFO:0001378
B-cell chronic lymphocytic leukemia	1	MONDO:0004948	EFO:0000095
myelodysplastic syndrome	1	MONDO:0018881	EFO:0000198
acute myeloid leukemia	1	MONDO:0018874	EFO:0000222
chronic myeloid leukemia	1	MONDO:0011996	EFO:0000339
neoplasm	1	MONDO:0005070	EFO:0000616
autoimmune disease	1	MONDO:0007179	EFO:0005809

Clinical trials

Total trials: 8.

Phase distribution

Phase	Trials
PHASE1	3
PHASE2	2
PHASE1/PHASE2	2
PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03786094	PHASE3	TERMINATED	Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
NCT01105403	PHASE2	COMPLETED	Exploratory Study on POL6326 in Stem Cell Mobilization
NCT01413568	PHASE1/PHASE2	COMPLETED	Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies
NCT01905475	PHASE2	COMPLETED	CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI)
NCT04826016	PHASE1/PHASE2	WITHDRAWN	POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer
NCT06981806	PHASE1	NOT_YET_RECRUITING	Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma
NCT01837095	PHASE1	COMPLETED	Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
NCT01841476	PHASE1	COMPLETED	Safety and Efficacy of POL6326 for Mobilization of Hematopoietic Stem Cells in Healthy Volunteers

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.

5 molecules share ≥1 primary target. Top 5 by shared-target count:

Molecule	Source	Status	Shared targets
MAVORIXAFOR	ChEMBL + PubChem	Phase 4 (approved)	CXCR4
CHLOROQUINE	ChEMBL	Phase 4 (approved)	CXCR4
PLERIXAFOR	ChEMBL	Phase 4 (approved)	CXCR4
ZALCITABINE	ChEMBL	Phase 4 (approved)	CXCR4
APLAVIROC	ChEMBL	Phase 3	CXCR4