Cerebrolysin (porcine brain peptides)

Other metabolic agents (local classification)

ATC code: V03AX-CEREBROLYSIN(Cerebrolysin (local code))

Updated 24 Sep 2026 · Methodology

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Ischemic stroke

Not recommended

Evidence tier D. The 2020 Cochrane systematic review on cerebrolysin in acute ischaemic stroke pooled randomised controlled trials and found no convincing reduction in mortality or dependency at follow-up. Reviewers rated evidence quality as low because of risk of bias in manufacturer-sponsored trials and heterogeneity of outcomes. The 2019 acute ischaemic stroke guideline and the 2021 guideline do not list cerebrolysin or other peptide neuroprotectants. Evidence-based acute therapy consists of intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours and mechanical thrombectomy within 6–24 hours in selected large vessel occlusions, followed by secondary prevention with antiplatelets, statins and blood pressure control.

Sources

ICD-10: I63 · ICD-11: 8B11

Dementia

Not recommended

Evidence tier F. Cerebrolysin is not mentioned in the , , or EAN dementia guidelines for Alzheimer disease or vascular dementia. A 2017 Cochrane review on cerebrolysin for vascular dementia concluded that data were insufficient to support routine clinical use. Available trials are small, mostly single-centre, sponsored by the manufacturer and report short-term changes on cognitive scales without consistent effects on activities of daily living or institutionalisation. Evidence-based therapy for Alzheimer dementia consists of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine, which produce modest symptomatic benefit but do not modify disease progression.

Sources

AAN: Practice Guideline Update: Mild Cognitive Impairment (2018)

ICD-10: F03 · ICD-11: 6D8Z

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

Cerebrolysin is a parenteral mixture of low molecular weight peptides and free amino acids enzymatically derived from porcine brain tissue. The manufacturer (Ever Pharma, Austria) claims neurotrophic activity mimicking endogenous nerve growth factor and brain-derived neurotrophic factor, anti-apoptotic effects, and modulation of amyloid processing. Independent characterisation of the active fraction is limited and the molecular composition is not standardised across batches. Cerebrolysin is widely prescribed in Russia, the EAEU, China and parts of Latin America for ischaemic stroke, traumatic brain injury and dementia. The product is not registered by the or and is not listed in the USP or European Pharmacopoeia. Mechanism claims have not been confirmed in independent preclinical or clinical research that meets contemporary methodological standards.

Safety

Contraindications

Allergic diathesis
Severe renal failure
Status epilepticus, grand mal seizures
Hypersensitivity

Serious adverse effects

Anaphylactic reactions (rare)
Seizures (rare)

Common adverse effects

Allergic skin reactions
Injection site redness and pain
Dizziness
Nausea

Pregnancy: can you take Cerebrolysin (porcine brain peptides)?

Use in pregnancy is not recommended due to limited data.

Breastfeeding: can you take Cerebrolysin (porcine brain peptides)?

There are no data on the transfer of cerebrolysin peptides into human milk. The product is a mixture of free amino acids and low-molecular peptides derived from porcine brain. The evidence base is weak: Cochrane systematic reviews (2020) in ischaemic stroke and vascular dementia did not confirm a clinically meaningful effect. Cerebrolysin is not authorised in Spain and is not recommended during breastfeeding.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

Cerebrolysin is manufactured by the Austrian company Ever Pharma and is widely used in neurological practice across Eastern Europe, Asia, and the CIS. It is not registered in the US, UK, or most Western European countries. The product is of biological origin (from pig brain), which historically raised theoretical prion concerns.

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Frequently asked

What is Cerebrolysin (porcine brain peptides) used for?

Cerebrolysin (porcine brain peptides) is evaluated for the following indications with varying evidence strength: Ischemic stroke (evidence tier D), Dementia (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Cerebrolysin (porcine brain peptides)?

Common side effects of Cerebrolysin (porcine brain peptides) (≥ 1 in 100): Allergic skin reactions, Injection site redness and pain, Dizziness, Nausea. See the Safety section for uncommon and serious reactions.

Is Cerebrolysin (porcine brain peptides) safe during pregnancy?

Use in pregnancy is not recommended due to limited data.

Is Cerebrolysin (porcine brain peptides) compatible with breastfeeding?

Who should not take Cerebrolysin (porcine brain peptides)?

Cerebrolysin (porcine brain peptides) is contraindicated in: Allergic diathesis; Severe renal failure; Status epilepticus, grand mal seizures; Hypersensitivity. Full list in the Safety section.

Official sources

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GRLS

Other drugs in this group

Cobicistat, Deferasirox, Ergoferon (antibodies to γ-interferon, CD4, and histamine in homeopathic dilutions), Methylthioninium chloride (methylene blue), Naloxone, Antibodies to S-100 brain-specific protein (homeopathic), Ethylmethylhydroxypyridine succinate, Anas Barbariae Hepatis et Cordis Extractum (homeopathic)