Cerebrolysin

Also known as: Brain-derived peptide preparation, FPF 1070

Evidence: Clinical

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Overview

Porcine brain-derived mixture of low-molecular-weight neuropeptides and free amino acids with neurotrophic activity; trialled in humans for stroke and dementia.

Cerebrolysin is a peptide preparation made from porcine brain, a mixture of low-molecular-weight peptides and free amino acids rather than a single compound. Most human research is in stroke. The CASTA randomized trial in Asia was neutral on its primary endpoint, a sponsor-linked meta-analysis of the CARS trials reported better motor recovery, and a 2023 Cochrane review found no effect on mortality with more non-fatal serious adverse events. It is sold in some countries under national authorisation, is not centrally authorised by EMA, and has no US approval.

Benefits

Motor recovery after ischemic stroke (human RCT meta-analysis, sponsor-affiliated), neurotrophic activity (preclinical, proposed)

Dosing reference

Research dose: 5-10 ml intramuscular

5-10 mL intramuscular injection. 10-20 day cycles. Pre-filled ampules, no reconstitution needed.

Mechanism

Cerebrolysin is a standardized porcine brain extract containing a mixture of low molecular weight neuropeptides (<10 kDa) and free amino acids. The peptide fraction contains neurotrophic factor-like activity similar to BDNF, GDNF, and NGF. Enhances neuroplasticity by promoting dendritic sprouting, synaptogenesis, and neurogenesis. Reduces neuronal apoptosis and oxidative damage. Modulates neurotransmitter systems including cholinergic and glutamatergic pathways. Also has anti-inflammatory effects reducing microglial activation in neuroinflammation.

Evidence

Clinical: at least one published human trial or an approved drug

In the CASTA double-blind placebo-controlled trial in acute ischemic stroke in Asia, the primary endpoint was neutral (Heiss et al., 2012)
A meta-analysis of the CARS trials reported better motor recovery after stroke; the authors include sponsor-affiliated investigators (Guekht et al., 2017)
A 2023 Cochrane review of acute ischaemic stroke trials found no mortality benefit and more non-fatal serious adverse events with Cerebrolysin, RR 2.39 (Ziganshina et al., 2023)
Human-trial status: stroke RCTs exist with mixed results. Not centrally authorised by EMA; marketed under national authorisations in some countries. No US approval: openFDA returns no application

References

Side effects

In the 2023 Cochrane review of acute ischaemic stroke trials, non-fatal serious adverse events were more frequent with Cerebrolysin than control (RR 2.39), with no mortality benefit (Ziganshina et al., 2023). Made from porcine brain tissue, relevant to hypersensitivity and to dietary or religious restrictions. Commonly reported (clinical use, not verified in this audit): injection-site reactions, dizziness, headache, agitation, rare hypersensitivity, and heat or sweating with rapid injection.

Storage

Storage: Refrigerated (2-8°C)
Lyophilized: 24+ months refrigerated

Pharmacology

Half-life: Not characterized; a mixture of peptides and amino acids has no single half-life, and no human PK study was found
Bioavailability: Given IV or IM; CNS penetration in humans is not measured