{"id":"cerebrolysin","name":"Cerebrolysin","aliases":["Cerebrolysin","FPF-1070","porcine brain peptide preparation"],"url":"https://lyoresearch.com/compounds/cerebrolysin","class":{"id":"nootropic-peptides","name":"Nootropic and sleep peptides","url":"https://lyoresearch.com/classes/nootropic-peptides"},"summary":"Cerebrolysin is a mixture of short peptides and amino acids extracted from pig brain, made in Austria and given as a course of daily intravenous infusions for stroke, dementia and brain injury in Russia, China, Eastern Europe and Asia. It is not approved in the United States, the United Kingdom or EU-wide. The Cochrane review of seven stroke trials found no effect on death and a doubling of non-fatal serious adverse events; the Cochrane review of six vascular-dementia trials found a small cognitive benefit on very low-quality evidence that may be too small to matter.","overall_grade":"C","overall_grade_meaning":"weak human evidence","human_trials":"7 RCTs in stroke (n=1,773); 6 RCTs in vascular dementia (n=597); many small trials","regulatory_status":"Approved in Austria, Russia, China and others; not US/UK/EU-wide","molecule":{"formula":null,"molecular_weight":null,"cas":null,"pubchem_cid":null,"note":"An undefined mixture of porcine brain peptides — no molecular identity"},"pharmacokinetics":{"basis":"none","route":"Intravenous or intramuscular as used clinically","half_life":"No pharmacokinetic data — an undefined peptide mixture has no single half-life","licensed_regimen":null,"product":null,"source":null},"outcomes":[{"outcome":"Survival after acute ischaemic stroke","grade":"A","grade_meaning":"established in humans","effect_size":"not measurable","adverse":false,"human_studies":"Cochrane review: 6 RCTs, 1,689 participants","evidence":"Moderate-certainty evidence of no effect on death. None of the trials reported the outcome that matters most — death or dependence — at all.","references":[{"citation":"Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke.","where":"Cochrane Database Syst Rev, 2023;10:CD007026","url":"https://pubmed.ncbi.nlm.nih.gov/37818733/"}],"verbatim":{"text":"All-cause death: Cerebrolysin or Cortexin probably result in little to no difference in all-cause death (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.65 to 1.41; 6 trials, 1689 participants; moderate-certainty evidence).","citation":"Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke.","url":"https://pubmed.ncbi.nlm.nih.gov/37818733/"}},{"outcome":"Cognition in vascular dementia","grade":"C","grade_meaning":"weak human evidence","effect_size":"small","adverse":false,"human_studies":"Cochrane review: 6 RCTs, 597 participants","evidence":"A small pooled benefit on cognitive scores, from trials the reviewers rated at high risk of bias and very low quality, with no new trials in a decade. Their own conclusion: if there are benefits, they may be too small to be clinically meaningful.","references":[{"citation":"Cui S, Chen N, Yang M, et al. Cerebrolysin for vascular dementia.","where":"Cochrane Database Syst Rev, 2019;11:CD008900","url":"https://pubmed.ncbi.nlm.nih.gov/31710397/"}],"verbatim":{"text":"Combining the MMSE and ADAS-cog+ data (three studies, 420 people), there was a beneficial effect of Cerebrolysin (SMD 0.36, 95% CI 0.13 to 0.58; very low-quality evidence).","citation":"Cui S, Chen N, Yang M, et al. Cerebrolysin for vascular dementia.","url":"https://pubmed.ncbi.nlm.nih.gov/31710397/"}},{"outcome":"Alzheimer's disease","grade":"C","grade_meaning":"weak human evidence","effect_size":"small","adverse":false,"human_studies":"Several small RCTs","evidence":"Small trials report modest short-term improvements on cognitive scales; no large or long trial, no regulatory approval in a major market for this use.","references":[{"citation":"Cerebrolysin randomised trials in Alzheimer's disease and traumatic brain injury.","where":"PubMed search","url":"https://pubmed.ncbi.nlm.nih.gov/?term=cerebrolysin+randomized+controlled+trial"}]},{"outcome":"Traumatic brain injury recovery","grade":"C","grade_meaning":"weak human evidence","effect_size":"small","adverse":false,"human_studies":"Small RCTs and cohort studies","evidence":"A mix of small randomised and observational studies from the countries where it is used; not independently confirmed at scale.","references":[{"citation":"Cerebrolysin randomised trials in Alzheimer's disease and traumatic brain injury.","where":"PubMed search","url":"https://pubmed.ncbi.nlm.nih.gov/?term=cerebrolysin+randomized+controlled+trial"}]},{"outcome":"Serious adverse events (stroke)","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":true,"human_studies":"Cochrane review: 3 RCTs, 1,335 participants","evidence":"Non-fatal serious adverse events were more than twice as common on Cerebrolysin, and more so at the higher cumulative dose — moderate-certainty evidence.","references":[{"citation":"Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke.","where":"Cochrane Database Syst Rev, 2023;10:CD007026","url":"https://pubmed.ncbi.nlm.nih.gov/37818733/"}],"verbatim":{"text":"This comprised fatal SAEs (RR 0.90, 95% CI 0.59 to 1.38; 3 trials, 1335 participants; moderate-certainty evidence) and an increase in the total number of people with non-fatal SAEs (RR 2.39, 95% CI 1.10 to 5.23; 3 trials, 1335 participants; moderate-certainty evidence).","citation":"Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke.","url":"https://pubmed.ncbi.nlm.nih.gov/37818733/"}}],"regions":[{"region":"European Union","status":"Authorised nationally in Austria and some member states","note":"No central (EU-wide) authorisation. Where authorised, prescription-only and given by infusion."},{"region":"United States","status":"Not approved","note":"Not FDA-approved; imported products are unapproved drugs."},{"region":"United Kingdom","status":"Unlicensed medicine","note":"No MHRA licence."},{"region":"Australia","status":"Not registered","note":"Not on the ARTG."},{"region":"Canada","status":"Not authorised","note":"No Drug Identification Number."},{"region":"Sport (WADA)","status":"Not on the list","note":"Not named on the Prohibited List."}],"faq":[{"q":"Does Cerebrolysin work for stroke?","a":"The Cochrane review of seven randomised trials found no effect on death and no reported data on dependence, with more serious adverse events on treatment. That is the best available summary, and it is negative."},{"q":"Does Cerebrolysin help dementia?","a":"A small pooled benefit on cognitive scores in vascular dementia, from trials of very low quality; the reviewers judged any benefit might be too small to be meaningful. No large, independent trial has been done in over a decade."},{"q":"Why is it approved in some countries and not others?","a":"It predates modern licensing standards in the countries where it is established, and the trial evidence has not met the bar of the FDA, MHRA or EMA. National approvals in Austria and elsewhere remain."}],"references":[{"cite":"Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke.","where":"Cochrane Database Syst Rev, 2023;10:CD007026","url":"https://pubmed.ncbi.nlm.nih.gov/37818733/","note":"Seven RCTs, 1,773 participants."},{"cite":"Cui S, Chen N, Yang M, et al. Cerebrolysin for vascular dementia.","where":"Cochrane Database Syst Rev, 2019;11:CD008900","url":"https://pubmed.ncbi.nlm.nih.gov/31710397/","note":"Six RCTs, 597 participants; very low-quality evidence."},{"cite":"Cerebrolysin randomised trials in Alzheimer's disease and traumatic brain injury.","where":"PubMed search","url":"https://pubmed.ncbi.nlm.nih.gov/?term=cerebrolysin+randomized+controlled+trial","note":"Small trials, largely from countries where the product is established."}],"last_reviewed":"2026-09-10","literature_searched_to":"2026-09-10","changelog":[{"date":"2026-09-10","note":"Initial publication. Stroke survival graded A (no effect) on moderate-certainty Cochrane evidence; dementia C."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}