Cerebrolysin: FDA Status and Evidence
A brain-derived peptide preparation sold abroad but not approved in the U.S. Most of the human research concerns acute stroke, with no clear benefit on death or dependency.
Medically reviewed by Charles Kamen, MD, board-certified neurologist · ·
What the research shows
Cerebrolysin is a mixture of peptides derived from pig brain tissue. Most trials tested it after acute stroke. A Cochrane review of those trials found no clear benefit on death or dependency and a possible increase in serious non-fatal adverse events.
Frequently Asked Questions
Is Cerebrolysin FDA-approved?
No. Cerebrolysin is not approved in the United States.
Can a U.S. pharmacy compound Cerebrolysin?
It is not on FDA's bulk-substance lists for compounding. Products sold in the U.S. are typically imported, unapproved drugs.
Does Cerebrolysin work for stroke?
A Cochrane review of stroke trials found no clear benefit on death or dependency.
Selected Research
Peer-reviewed sources on Cerebrolysin. Research does not constitute a treatment recommendation; appropriateness is determined only after a medical evaluation.
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