Cerebrolysin Research Profile

Cerebrolysin

FPF1070

Cerebrolysin (FPF1070) is a porcine-brain-derived peptide and free-amino-acid mixture marketed by Ever Neuro Pharma. It is approved in many countries (including parts of Europe and Asia) for stroke, traumatic brain injury, and dementia, but is not FDA-approved in the United States. Multiple Cochrane systematic reviews have evaluated the evidence base — the most recent stroke update (2023) reports no mortality benefit and a possible increase in non-fatal serious adverse events.

Dossier overview

research areas

references

handling notes

Mechanism of action

Cerebrolysin is characterised as a 'neurotrophic' mixture with peptides and free proposed to support neuronal survival and plasticity. Because the preparation is not a defined molecule, mechanism attribution is challenging — the Cochrane reviews note significant heterogeneity across the underlying trial evidence.

Research applications

Acute ischaemic stroke clinical research
Vascular dementia clinical research
Traumatic brain injury clinical research
Comparative neurotrophic-mixture research

Evidence at a glance

What's behind this profile

3 citations · 2017–2023

Review: 3

Publication years

20172023

Counts are derived from the cited studies below. A study covering both in vivo and in vitro work is counted by its primary model. Sample size is reported in 3 of 3 citations. Findings remain model-specific and are not extrapolated to therapeutic use.

Study references

Each profile cites a minimum of two peer-reviewed sources, with model type and reported sample size where the source provides it. Findings are model-specific and must not be extrapolated to therapeutic use.

Cerebrolysin for vascular dementia

2019

Cui S et al. · Cochrane Database of Systematic Reviews

Model: Cochrane systematic review and meta-analysis
Sample: n=597 across 6 RCTs

Reported modest cognitive improvement signals in vascular dementia trials but rated evidence quality as very low; clinical significance was assessed as questionable.

PMID 31710397 DOI 10.1002/14651858.CD008900.pub3

Cerebrolysin for acute ischaemic stroke

2017

Ziganshina LE et al. · Cochrane Database of Systematic Reviews

Model: Cochrane systematic review and meta-analysis
Sample: n=1501 across 6 RCTs

Reported no mortality benefit in acute ischaemic stroke and noted an increase in non-fatal serious adverse events in the pooled evidence.

PMID 28430363 DOI 10.1002/14651858.CD007026.pub5

Cerebrolysin for acute ischaemic stroke (2023 update)

2023

Ziganshina LE et al. · Cochrane Database of Systematic Reviews

Model: Cochrane systematic review and meta-analysis update
Sample: n=1773 across 7 RCTs

Updated Cochrane evidence confirmed no all-cause mortality benefit in acute ischaemic stroke and a possible increase in non-fatal serious adverse events.

PMID 37818733 DOI 10.1002/14651858.CD007026.pub7

Evidence caveats

Cerebrolysin is approved in many jurisdictions but not FDA-approved in the United States.
The most recent Cochrane systematic review (Ziganshina 2023) reports no mortality benefit in acute ischaemic stroke and a possible increase in non-fatal serious adverse events. Evidence quality across the underlying trials is heterogeneous.

Storage and handling

Approved product follows manufacturer instructions. Research-grade material must be stored under controlled laboratory conditions per protocol.

Approved product follows the manufacturer cold-chain.
Research-grade material requires controlled laboratory storage and batch documentation.
Verify product source carefully — Cerebrolysin is a brand-specific preparation produced by Ever Neuro Pharma, not a generic compound.

Research Access Confirmation