Peptide preparation
Cerebrolysin is a porcine brain-derived peptide preparation (neuropeptide concentrate) with proposed neurotrophic and neuroprotective activity. It is approved and marketed in over 40 countries for neurological indications including stroke and dementia, but is NOT approved by the FDA for use in the United States. Over 100 clinical trials have been conducted, primarily outside the US. Cochrane systematic reviews have examined its use in vascular dementia with mixed conclusions.
Clearly state that Cerebrolysin is not FDA-approved and not legally available in the United States. Present international clinical trial data without recommending use. Do not publish dosing protocols or sourcing instructions. Track regulatory status across jurisdictions.
A Cochrane systematic review examined Cerebrolysin for vascular dementia, finding it is used as daily intravenous infusions in many countries but concluding results were inconsistent and higher-quality trials are needed (Cui et al., Cochrane Database Syst Rev, 2019; CD008900).
A 2025 prospective, randomized, open-label, blinded-endpoint pilot trial (CLINCH) evaluated Cerebrolysin for intracerebral hemorrhage, finding it was safe and feasible to study (Kobayashi et al., Front Neurol, 2025).
A 2026 systematic review and meta-analysis found Cerebrolysin as an adjunct to mechanical thrombectomy in acute ischemic stroke showed promise but required further study (Brain Behav, 2026).
Cerebrolysin is not approved by the FDA for any indication. It is manufactured by Ever Pharma (Unterach, Austria) and is available in over 40 countries, primarily in Europe and Asia.
Evidence level: Primary regulatory
Sources: PubMed / NCBI, Wikipedia
Confirm regulatory status on each review cycle. The compound cannot be legally prescribed or sold in the United States. Update immediately if FDA status changes.
Evidence level: Peer reviewed
Sources: PubMed / NCBI, PubMed / NCBI, PubMed / NCBI
Cite the Cochrane review and key trials directly. The Cochrane review noted inconsistent results and need for higher-quality trials. Do not present as established therapy.
Evidence level: Preclinical
Sources: PubMed / NCBI, Wikipedia
Mechanistic claims are supported by preclinical data. Clinical evidence is mixed. The Cochrane review specifically noted inconsistency in results.
Source records are stored in the repo and linked from each claim.
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