Cerebrolysin

Neuroprotective Peptide Mixtureapproved (non-US)

Also known as: FPF-1070, Cerebrolysate

A porcine brain-derived peptide preparation containing low-molecular-weight neuropeptides and free amino acids, used clinically in many countries for stroke recovery, traumatic brain injury, and dementia.

Overview

Cerebrolysin is a unique neuropeptide preparation derived from purified porcine brain proteins through standardized enzymatic proteolysis. It contains approximately 25% low-molecular-weight peptides (under 10 kDa) and 75% free amino acids. Unlike most research peptides, Cerebrolysin has an extensive clinical history and is approved as a pharmaceutical drug in over 50 countries (though not in the US) for conditions including stroke, traumatic brain injury, Alzheimer's disease, and vascular dementia. Its neurotrophic activity mimics the effects of naturally occurring nerve growth factors, promoting neuronal survival, synaptogenesis, and neuroplasticity. Multiple randomized controlled trials have demonstrated its efficacy in post-stroke recovery and moderate improvements in cognitive function in dementia patients.

Mechanism of Action

Cerebrolysin exerts multimodal neurotrophic and neuroprotective effects: (1) Mimics the action of BDNF, GDNF, NGF, and CNTF through contained neuropeptide fragments; (2) Activates PI3K/Akt survival signaling and inhibits GSK-3β, reducing tau hyperphosphorylation; (3) Promotes neurogenesis and synaptogenesis in the hippocampus; (4) Reduces excitotoxicity by modulating glutamate receptor activity; (5) Exerts anti-apoptotic effects on neurons under oxidative stress; (6) Enhances oligodendrogenesis and supports remyelination; (7) Modulates inflammatory cytokines in the CNS, reducing neuroinflammation.

Molecular Formula

Complex mixture — no single formula

Molecular Weight

< 10,000 Da (peptide fraction)

Sequence

Complex mixture of peptide fragments — no single sequence

Dosage Protocols

Dose Range

5ml10ml

Frequency

Once daily

Route

intramuscular

Cycle Length

10-20 days per cycle, repeated as needed

Standard clinical protocol uses 5-10ml IM daily for 10-20 day courses. Multiple courses may be given with 2-4 week breaks. Contains 215.2 mg/ml of active peptide concentrate.

Source: Official prescribing information (EVER Pharma)

Side Effects

EffectSeverity
Injection site painmild
Dizzinessmild
Headachemild
Nauseamild
Agitationmoderate
Allergic reactionsevere

Pros & Cons

Extensive clinical evidence with multiple RCTs supporting efficacy in stroke and dementia

Approved pharmaceutical in 50+ countries with decades of clinical use

Multimodal mechanism provides broad neuroprotection rather than targeting a single pathway

Well-characterized safety profile from large clinical trials

Not FDA-approved — difficult to obtain in the United States

Requires injection (IM or IV); no oral formulation available

Derived from porcine brain tissue — ethical concerns and allergy risk for some

High-dose IV protocols require clinical supervision

Complex mixture makes precise mechanism characterization challenging

Research Studies

Legal Status

Approved pharmaceutical in over 50 countries (Europe, Asia, South America). Not FDA-approved in the United States. Available by prescription in approved countries. Can be sourced as a research chemical in the US.

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