Is Cerebrolysin legal in the US?
No. It is not approved in the US; it is licensed in over 50 other countries.
Cerebrolysin is not approved by the FDA for any use. It is a licensed medicine in more than 50 other countries, mainly in Eastern Europe, Russia and Asia, for stroke, dementia and brain injury. 13
Not as an approved drug. The FDA has approved no Cerebrolysin product. So a US pharmacy has nothing to dispense. Vials sold online are imported drug product of uncertain handling. 1
It was licensed decades ago in markets with different evidence standards at the time. It stayed on those markets while the record of controlled trials grew. The trials that show benefit are small and mostly company-backed. The independent synthesis is neutral to negative. 13
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More on Cerebrolysin
Citations
- 2021, Neurol Sci: Cerebrolysin for stroke, neurodegeneration and TBI, review pubmed.ncbi.nlm.nih.gov
- 2021, Neurol Sci: prospective meta-analysis of the CAPTAIN trials in TBI pubmed.ncbi.nlm.nih.gov
- Ziganshina 2017, Cochrane: Cerebrolysin for acute ischaemic stroke pubmed.ncbi.nlm.nih.gov
- Cochrane CD007026, latest update: Cerebrolysin for acute ischaemic stroke doi.org
- Cochrane CD008900: Cerebrolysin for vascular dementia doi.org
- Muresanu 2016, Stroke: Cerebrolysin and recovery after stroke (CARS) pmc.ncbi.nlm.nih.gov
- 2014, Kaohsiung J Med Sci: neuroprotective properties of Cerebrolysin doi.org
- 2006, Acta Neuropathol: anti-apoptotic effects of Cerebrolysin in experimental models doi.org
- Springer chapter: Cerebrolysin and excitotoxic neuronal damage doi.org
Reference information only, not medical advice. Drawn from the Cerebrolysin article, fact-checked against the cited sources. No dosing anywhere on this site.