Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Spexis AGn = 43230 May 2019 to 19 Oct 2021
Metastatic Breast Cancer · Locally Recurrent Breast Cancer
PepBank has 5 balixafortide studies with results. 4 of them gave balixafortide, with 20 results, grouped by what the studies measured. In each group, results from studies in people come first. Data as of 2026-10-30.
Searches 20 results and 19 papers. Newer studies from Europe PMC
Identifiers, parent molecule, targets and development stage, from curated data.
Balixafortide is a 16-residue cyclic peptide, also called POL6326. It includes a diaminobutyric acid residue and D-proline substitutions. It differs from motixafortide and CXCR4-targeted imaging conjugates.
| Target | Action | Evidence |
|---|---|---|
| CXCR4CXCR4P61073 (opens in a new tab) | Antagonist | IUPHAR identifies CXCR4 antagonism. UniProt identifies human CXCR4 as P61073.Source (opens in a new tab) |
Residues, differences from the parent, calculated properties and 3D structure. Source values and calculated values are shown separately.
16 amino acids · 5 modifications · 1 disulfide bond
Some values cannot be calculated. The sequence has a non-canonical residue (X). Residue tables cover only the 20 standard amino acids.
@pepdb/chem 0.2.0 · EMBOSS pKa set · ExPASy residue masses
No charge curve
The sequence has a non-canonical residue (X). Residue tables cover only the 20 standard amino acids.
16 residues. Each residue counts in one class; F and W count as aromatic.
No 3D structure
No experimental structure (PDB) and no UniProt entry for an AlphaFold model are listed for this peptide. Synthetic peptides often have neither. The sequence view above is the reference.
An ideal alpha-helix projection. It shows where the hydrophobic residues fall if the peptide folds as a helix. It does not show that it does.
Eisenberg consensus (normalized) scale · + K, R · − D, E
Assumes an ideal α-helix: 100° per residue, 3.6 residues per turn. The arrow is the mean hydrophobic moment (Eisenberg et al. 1984) and points at the hydrophobic face.
| Position | Residue | Angle | Eisenberg consensus (normalized) |
|---|---|---|---|
| 1 | A | 0° | 0.62 |
| 2 | C | 100° | 0.29 |
| 3 | S | 200° | -0.18 |
| 4 | A | 300° | 0.62 |
| 5 | P | 40° | 0.12 |
| 6 | X | 140° | not scored |
| 7 | R | 240° | -2.53 |
| 8 | Y | 340° | 0.26 |
| 9 | C | 80° | 0.29 |
| 10 | Y | 180° | 0.26 |
| 11 | Q | 280° | -0.85 |
| 12 | K | 20° | -1.50 |
| 13 | P | 120° | 0.12 |
| 14 | P | 220° | 0.12 |
| 15 | Y | 320° | 0.26 |
| 16 | H | 60° | -0.40 |
People first in each area, then animals, then lab cells. Counts are exact and come from studies that gave the peptide.
PepBank reads each paper before it shows the results. This search looks in Europe PMC for newer papers that PepBank has not read yet.
Counts are exact and come from studies that gave the peptide.
Studies by year
5 of 19 studies have results (26%), published 2017 to 2025. Top row: every study. Bottom row: studies with results about Balixafortide, by class. The rows use different scales.
Studies19 in all, 2012 to 2026
Studies with results5 in all, 2017 to 2025
Retracted studies are left out. A study with results in two classes counts in both.
AI wrote and checked these results. AI can make mistakes, so check important results against the source.
Registered trials that test the peptide, with phase, status and dates. A dot marks trials with posted results.
8 trials match. Highest phase first. Data from ClinicalTrials.gov.
8 trials · 1 not yet recruiting · 5 completed · 2 stopped early · 1 with posted results
Safety and Efficacy of POL6326 for Mobilization of Hematopoietic Stem Cells in Healthy Volunteers
NCT01841476Feb 2012 to Sept 2015
Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies
NCT01413568Apr 2012 to Dec 2015
Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
NCT01837095Jun 2013 to Aug 2018
Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma
NCT06981806est. Jan 2026 to est. Feb 2027
8 trials · 1 not yet recruiting · 5 completed · 2 stopped early · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)
Spexis AGn = 43230 May 2019 to 19 Oct 2021
Metastatic Breast Cancer · Locally Recurrent Breast Cancer
MedSIRn = 016 Mar 2022 to 16 Mar 2022
Advanced Breast Cancer
Polyphor Ltd.n = 120Jul 2013 to Jun 2016
Large Reperfused ST-Elevation Myocardial Infarction
Polyphor Ltd.n = 38Apr 2012 to Dec 2015
Acute Myeloid Leukemia in Remission · Adult Acute Lymphoblastic Leukemia in Remission · Chronic Myelogenous Leukemia (CML) · Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease (HD) in 2nd or Greater Complete Remission, Partial Remission · Chronic Lymphocytic Leukemia (CLL) · Multiple Myeloma (MM) · Myelodysplastic Syndrome (MDS) · Myeloproliferative Disorders
Polyphor Ltd.n = 21Apr 2009 to Apr 2014
Multiple Myeloma
Arsen Osipovn = 24est. Jan 2026 to est. Feb 2027
Metastatic Pancreatic Ductal Adenocarcinoma
Polyphor Ltd.n = 54Jun 2013 to Aug 2018
Metastatic Breast Cancer
Polyphor Ltd.n = 27Feb 2012 to Sept 2015
Healthy
1 more mentions it but does not test it. They are not trials of Balixafortide: they only measure it (a blood level or an eligibility term) or name it in their text.
Studies on this peptide. Some have results. The others have none yet.
19 studies match. Retracted studies are left out.
Showing 19 of 19 studiesquery qry_d7197698279fe9beb5e8f283
5 studies
Not a test of Balixafortide alone · 2018
Pernas et al. 2018The Lancet. Oncologycited by 116
PMID 29706375DOI 10.1016/s1470-2045(18)30147-5PUB-29706375
Animal study (in vivo) · pig · 2019
Wang et al. 2019Circulationcited by 107
PMID 30696265PMC6467561DOI 10.1161/circulationaha.118.036053PUB-30696265
Non-randomized trial · 2017
Karpova et al. 2017Journal of translational medicinecited by 42
PMID 28049490PMC5209880DOI 10.1186/s12967-016-1107-2PUB-28049490
Animal study (in vivo) · mouse · 2025
Ciavattone et al. 2025Scientific reportscited by 22
PMID 39939722PMC11822021DOI 10.1038/s41598-025-89882-5PUB-39939722
Animal study (in vivo) · mouse · 2023
Robinson et al. 2023The Prostatecited by 12
PMID 37244751PMC10576997DOI 10.1002/pros.24584PUB-37244751
14 studies
PubMed tag: Review · 2020
Miao et al. 2020Expert opinion on drug metabolism & toxicologycited by 100
PMID 31903790DOI 10.1080/17425255.2020.1711884PUB-31903790
PubMed tag: Review · 2020
Huynh et al. 2020Pharmacological researchcited by 73
PMID 32758634DOI 10.1016/j.phrs.2020.105092PUB-32758634
PubMed tag: Review, Evaluation Study · 2012
de Nigris et al. 2012Recent patents on anti-cancer drug discoverycited by 49
PMID 22376154DOI 10.2174/157489212801820039PUB-22376154
PubMed tag: Review · 2021
Martin et al. 2021Journal of leukocyte biologycited by 26
PMID 33089889DOI 10.1002/jlb.5bt1219-714rPUB-33089889
PubMed tag: none · 2023
Zhu et al. 2023Cancer researchcited by 21
PMID 37540231PMC10570679DOI 10.1158/0008-5472.can-22-3432PUB-37540231
PubMed tag: review-article, Review · 2025
Singh et al. 2025Cellscited by 12
PMID 41002447PMC12468594DOI 10.3390/cells14181482PUB-41002447
PubMed tag: review-article, Review · 2026
Rajendran et al. 2026Cancer pathogenesis and therapycited by 5
PMID 41732212PMC12925104DOI 10.1016/j.cpt.2025.08.003PUB-41732212
PubMed tag: none · 2021
Batur et al. 2021Chimiacited by 4
PMID 34233814DOI 10.2533/chimia.2021.508PUB-34233814
PubMed tag: review-article, Review · 2026
Liao et al. 2026Biomoleculescited by 3
PMID 41750259PMC12938481DOI 10.3390/biom16020188PUB-41750259
PubMed tag: review-article, Review · 2026
Dhamecha et al. 2026American journal of nuclear medicine and molecular imagingcited by 1
PMID 41868688PMC13003231DOI 10.62347/rxpv2461PUB-41868688
Indexing hint: Animal study · 2025
Brenner et al. 2025Tomography (Ann Arbor, Mich.)
PMID 40863873PMC12390422DOI 10.3390/tomography11080082PUB-40863873
PubMed tag: none · 2026
Zhu et al. 2026Journal of pharmaceutical and biomedical analysis
PMID 42475801DOI 10.1016/j.jpba.2026.117658PUB-42475801
PubMed tag: Review · 2026
Jiang et al. 2026Cardiovascular drugs and therapy
PMID 42720723DOI 10.1007/s10557-026-07955-7PUB-42720723
PubMed tag: Preprint · 2025
Barnabei et al. 2025bioRxiv
DOI 10.1101/2025.07.10.664047PUB-95885782
Page 1 of 1
Karpova D · Journal of translational medicine · 2017
Non-randomized trial · 9 results
Wang Y · Circulation · 2019
Animal study (in vivo) · pig · 2 results
Ciavattone NG · Scientific reports · 2025
Animal study (in vivo) · mouse · 12 results
Robinson T · The Prostate · 2023
Animal study (in vivo) · mouse · 13 results
Pernas S · The Lancet. Oncology · 2018
Not a test of Balixafortide alone · 18 results
Approval and sport status, and the safety outcomes reported in study results. Laws and labels change, so check the regulator for the current status.
| Jurisdiction | Body | Status | As of | Source |
|---|---|---|---|---|
| US | FDA | The openFDA Drugs@FDA ingredient query returned no matches. This query does not establish exhaustive absence of approval. FDA UNII registration establishes identity, not approval. | 27 Oct 2026 | api.fda.gov (opens in a new tab) |
| EU | EMA | The FORTRESS EU registry identifies balixafortide as an investigational product without marketing authorisation in that record. Current central and national approvals remain unconfirmed. EMA medicine records do not cover all national authorisations. | 27 Oct 2026 | clinicaltrialsregister.eu (opens in a new tab) |
| Sport | WADA | Status unknown Balixafortide is not named in the 2026 list. | 2026 List | wada-ama.org (opens in a new tab) |
1 safety result for Balixafortide.
In healthy male volunteers, balixafortide was well tolerated.
Non-randomized trialn not reported
The doses that these studies used. They are not recommendations.
500-2500 µg/kgHuman
1500-2500 µg/kgHuman
3 mg/kg at 4, 6, 8, and 10 daysAnimal
20 mg/kg twice dailyAnimal
PepBank is a research reference. Talk to a doctor before you use any peptide.
Data version, change history and code for this peptide.
curl -s https:// pepbank.io/ v1/ briefs/ balixafortideEvidence summary for Balixafortide: counts by class, key results with sources, notices, data version.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated
Top outcomes
The 8 outcome groups with the most study results, by evidence class.
Data version 308560. Bar length is the number of results, not the size of an effect.
Evidence matrix
Study results by outcome and evidence class. Arrows show how the measured outcome moved, not whether the change is good.
| Outcome group | Human | Animal | Lab | Computer model | Total |
|---|---|---|---|---|---|
| Immune responseImmune and inflammation | Human: 7 results from 1 study: 3 increase, 2 decrease, 2 not reported. Strongest design: Non-randomized trial | Animal: 2 results from 2 studies: 2 increase. Strongest design: Animal study (in vivo) | No results | No results | 9 |
| Adverse eventsWhole body | Human: 1 result from 1 study: 1 not reported. Strongest design: Non-randomized trial | No results | No results | No results | 1 |
| Patient-reported outcomesWhole body | Human: 1 result from 1 study: 1 increase. Strongest design: Non-randomized trial | No results | No results | No results | 1 |
| Tumor growthCancer | No results | Animal: 3 results from 2 studies: 1 increase, 2 decrease. Strongest design: Animal study (in vivo) | No results | No results | 3 |
| Bone and jointMusculoskeletal | No results | Animal: 2 results from 1 study: 2 no significant change. Strongest design: Animal study (in vivo) | No results | No results | 2 |
| Heart functionCardiovascular | No results | Animal: 2 results from 1 study: 1 increase, 1 decrease. Strongest design: Animal study (in vivo) | No results | No results | 2 |
| MortalityCancer | No results | Animal: 1 result from 1 study: 1 increase. Strongest design: Animal study (in vivo) | No results | No results | 1 |
| Receptor activity and mechanismPharmacology | No results | No results | Lab: 1 result from 1 study: 1 not reported. Strongest design: In vitro (cells) | No results | 1 |
8 outcome groups shown of 8 · 20 study results
Data version 308560. Shade grows with the number of results. Every cell shows the exact count.
Trials by phase
8 registered trials, grouped by phase and shown by status.
Source: ClinicalTrials.gov, data version 308560. Status is the registry status.