Is Balixafortide legal in the US?
No. It is not approved. Only an early trial in pancreatic cancer is registered.
Balixafortide is an investigational peptide developed by Polyphor and is not approved by the FDA or any other regulator. Its phase 3 trial in breast cancer (FORTRESS) failed in 2021 and the sponsor closed the study without seeking approval. The only trial registered since then is an investigator-led phase 1 study combining it with cosibelimab in metastatic pancreatic cancer, posted in 2025 and not yet recruiting at its last update.
No. It failed its phase 3 trial in 2021, and Polyphor closed the study without seeking approval. The only trial registered since is an investigator-led phase 1 study with cosibelimab in pancreatic cancer, not yet recruiting at its last update. It has not been approved anywhere. 24
Read the full Balixafortide page
More on Balixafortide
Citations
- Pernas 2018, Lancet Oncology: balixafortide plus eribulin in HER2-negative metastatic breast cancer, phase 1 trial pubmed.ncbi.nlm.nih.gov
- Clinical Trials Arena: Polyphor's balixafortide fails phase 3 FORTRESS breast cancer study clinicaltrialsarena.com
- OncLive, June 2021: balixafortide plus eribulin fails to improve response rate in the FORTRESS trial onclive.com
- ClinicalTrials.gov: NCT06981806, balixafortide with cosibelimab in pancreatic cancer clinicaltrials.gov
Reference information only, not medical advice. Drawn from the Balixafortide article, fact-checked against the cited sources. No dosing anywhere on this site.