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Cerebrolysin

Cerebrolysin (porcine brain-derived peptide preparation; FPF-1070)

Late-Stage ClinicalInvestigationalMixed / Secondary ResultsPorcine Brain-Derived Peptide Extract

Clinical trials showed mixed results. Benefits were seen on some measures but not others.

An injectable medication derived from pig brain tissue that provides brain cell-nourishing support, used clinically in over 40 countries for stroke recovery, traumatic brain injury, and dementia. It has not been approved by the US FDA or European EMA, but is widely used in Europe, Asia, and Russia.

12 studiesUpdated 2026-03-12Intravenous (IV) -- primary clinical route; up to 10 mL slowly over ~3 min undiluted, or 10-50 mL diluted in ≥100 mL saline infused over 15-60 min · Intramuscular (IM) -- up to 5 mL per injection undiluted, injected slowly over ~3 min

This entry is a cited research summary, not an established treatment reference. Dosing language is included as source context, not as medical instruction.

Clinical bottom lineMixed evidence

Cerebrolysin has substantial clinical evidence but is not FDA-approved.

Clinical trials showed mixed results. Benefits were seen on some measures but not others.

Safety Summary

Overall safety profile is favorable. Acute adverse events are generally mild, transient, and occur at rates comparable to placebo in randomized trials. Slow administration recommended to reduce flushing/palpitations risk. No preclinical or clinical evidence of carcinogenicity or oncogenic signaling. However, a Cochrane review PMC6478305 noted a potential excess of non-fatal SAEs in the cerebrolysin group in pooled acute stroke analyses. Long-term/chronic use safety data are limited but available observational data do not suggest cumulative toxicity; PMC7387239.

Clinical check-in

If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.

See cited studies on this page (12)

Cited sources

Every claim on this page links to one of the 12 sources below. Identifiers are PubMed (PMID), ClinicalTrials.gov (NCT), or DOI; click through to the source of record before acting on a claim.

  1. 1PMID 22514792PubMed
  2. 2PMID 26564102PubMed
  3. 3Efficacy and safety of Cerebrolysin in early recovery after acute ischemic strokeReference
  4. 4PMID 31897816PubMed
  5. 5PMID 41739286PubMed
  6. 6PMID 41577696PubMed
  7. 7PMID 21679156PubMed
  8. 8PMID 32808294PubMed
  9. 9PMID 33515100PubMed
  10. 10PMID 31710397PubMed
  11. 11PMID 23656173PubMed
  12. 12PMID 36074398PubMed