Balixafortide
An investigational cyclic peptide CXCR4 antagonist studied in breast cancer.
- Evidence grade
- CEarly Human Research
Early Human Research
- Regulatory status
- Not FDA Approved
Not FDA-approved; the phase 3 FORTRESS trial was terminated after its primary endpoint was not met.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
An investigational cyclic peptide CXCR4 antagonist studied in breast cancer.
Not FDA-approved; the phase 3 FORTRESS trial was terminated after its primary endpoint was not met.
Early activity is not established anticancer efficacy; a terminated negative phase 3 trial should not be described as ongoing success.
Why It's Being Studied
- Advanced breast cancer
- CXCR4 antagonism
Mechanism of Action
CXCR4 blockade is intended to alter tumor and microenvironment signalling, but clinical benefit must be demonstrated independently.
CXCR4 blockade is intended to alter tumor and microenvironment signalling, but clinical benefit must be demonstrated independently. Early activity is not established anticancer efficacy; a terminated negative phase 3 trial should not be described as ongoing success.
From molecular target to clinical evidence
Tap each stage to see what happens.
Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- Advanced breast cancer
- CXCR4 antagonism
- Intravenous clinical research
Evidence Summary
Phase 3 FORTRESS with eribulin was terminated after failure to meet the primary endpoint.
Higher tiers carry more weight. Filled tiers have evidence for Balixafortide; tap to read it.
- Phase 3 FORTRESS with eribulin was terminated after failure to meet the primary endpoint.
1 cited sources.
- Regulatory document1
Human clinical evidence
- Phase 3 FORTRESS with eribulin was terminated after failure to meet the primary endpoint.
Reported Adverse Events in Research
- Infusion or hypersensitivity risks and combination-treatment toxicity remain relevant.
Limitations of Current Evidence
- Early activity is not established anticancer efficacy; a terminated negative phase 3 trial should not be described as ongoing success.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Balixafortide | Trofinetide | |
|---|---|---|
| Evidence grade | C — Early Human Research | B — Moderate Human Evidence |
| Regulatory status | Not FDA Approved | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Intravenous clinical research | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Regulatory document
Balixafortide — regulatory document