Other metabolic agents (local classification)
ATC code: V03AX-CEREBROLYSIN (Cerebrolysin (local code))
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.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
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.
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.
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Use in pregnancy is not recommended due to limited data.
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.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
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.
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.
FDA category N. Use in pregnancy is not recommended due to limited data.
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.
Cerebrolysin (porcine brain peptides) is contraindicated in: Allergic diathesis; Severe renal failure; Status epilepticus, grand mal seizures; Hypersensitivity. Full list in the Safety section.