Cerebrolysin

Discover Cerebrolysin, a peptide aiding neurological health and cognitive research.

Educational summaryPeptide research profile

Also known as: 215 mg/mL, 10 mL

(how we review)

Dosing & scaling, explained

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Evidence context

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Storage, handling and interpretation

Product identity

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Storage & handling

Follow the product label, certificate and validated laboratory SOP; no universal storage assumption is applied here.

Prepared solutions

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Reported protocols for Cerebrolysin

What published studies and recent community write-ups report about amounts, timing and course length. 8 clinical and 3 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.

ContextDoseFrequencyRouteCourseSource
Clinical8 rows
Manufacturer dosage recommendation (Austrian label basis)Adults with stroke, traumatic brain injury, Alzheimer's disease or vascular dementia20-50 mL per day (stroke, TBI); 10-30 mL per day (dementia and cognitive impairment)Once daily; dementia cycles run 5 days a weekIntramuscular up to 5 mL undiluted over 3 minutes; intravenous push up to 10 mL undiluted; 10-50 mL diluted to at least 100 mL and infusedStroke 10-21 days; TBI 7-30 days; dementia 4 weeks per cycleDementia cycles repeated 2-4 times per yearEVER Neuro Pharma (cerebrolysin.com)2026
EVER Pharma's dosage card gives 20-50 mL a day for stroke and traumatic brain injury started as early as possible, and 10-30 mL a day, five days a week for four weeks, repeated two to four times a year, for Alzheimer's disease, vascular dementia and cognitive problems. Any amount above 5 mL has to be given intravenously, the ampoule must be used immediately once opened, and the product must not be mixed with amino acid, vitamin or cardiovascular solutions; the prescribing text lists hypersensitivity, epilepsy and severe renal impairment as contraindications.
CASTA trial, acute ischaemic stroke in Asia1,070 adults with acute hemispheric ischaemic stroke, randomized within 12 hours of onset (529 Cerebrolysin, 541 placebo)30 mLOnce dailyIntravenous infusion, plus aspirin 100 mg daily10 days, with follow-up to day 90Not applicableStroke (PubMed)2012
The confirmatory combined endpoint (modified Rankin Scale, Barthel Index and NIHSS) showed no difference between groups. A post hoc analysis of the severely affected subgroup favoured Cerebrolysin, with 90-day mortality of 10.5% against 20.2% on placebo, a finding the authors present as a trend to be tested rather than a result.
CARS trial, early stroke rehabilitationAdults 24-72 hours after ischaemic stroke entering a standardized 21-day rehabilitation programme30 mLOnce dailyIntravenous21 days, with the primary endpoint at day 90Not applicableStroke (PubMed)2016
Upper-limb function on the Action Research Arm Test at day 90 showed a large effect size in favour of Cerebrolysin (Mann-Whitney estimator 0.71) and a global multivariate measure a small-to-medium one, with premature discontinuation under 5% and safety comparable to placebo. The authors call the study exploratory because of its modest size, and several of them are employees or consultants of the manufacturer.
Pooled CARS-1 and CARS-2 analysis442 adults with acute ischaemic stroke in early rehabilitation30 mLOnce dailyIntravenous, started 24-72 hours after stroke onset3 weeks alongside 21 days of rehabilitationNot applicableNeurological Sciences (PubMed)2017
The pre-planned pooling of two identical trials found superiority on the day 90 Action Research Arm Test (Mann-Whitney 0.62) and on early NIHSS change, with a number needed to treat of 7.1 for a clinically relevant early NIHSS improvement. The pooling was pre-planned under blinded conditions, and the paper's conflict statement lists manufacturer employees, grant recipients and paid consultants among the authors.
CAPTAIN II trial, moderate to severe traumatic brain injury142 adults with traumatic brain injury and a Glasgow Coma Score of 7-12 (139 analysed)50 mL per day for the first cycle, then 10 mL per dayOnce dailyIntravenous, added to standard care10 days at 50 mL, followed by two further 10-day cycles at 10 mLGaps between the three 10-day cyclesNeurological Sciences (PubMed)2020
A multidimensional ensemble of 13 outcome scales showed a small-to-medium effect in favour of Cerebrolysin at day 90 (Mann-Whitney 0.59), with safety comparable to placebo. The smaller Asian-Pacific CAPTAIN I trial (46 patients) used the same regimen and only reached significance in its per-protocol analysis, and the prospective meta-analysis of both trials (185 patients) reported the same small-to-medium effect at days 30 and 90.
Alzheimer's disease dose-ranging trial279 adults with mild to moderate Alzheimer's disease10, 30 or 60 mL5 days a week for 4 weeks, then twice a week for 8 weeksIntravenous infusion12 weeks of infusions, assessed at weeks 4, 12 and 24Not applicableEuropean Journal of Neurology (PubMed)2006
At week 24 only the 10 mL dose improved both cognition (ADAS-cog) and global impression, while 30 and 60 mL improved the global rating but not cognition, which the authors describe as a reversed U-shaped dose response. Adverse event rates were similar across groups, and because only the lowest dose met both endpoints, the labelled 10-30 mL range spans the most and the least effective doses in this trial.

How a course is commonly described

  1. Days 1-10Community-reported

    Community courses start at 5 mL intramuscularly each morning with no titration, and guides place the first subjective change around days 4-10. The acute stroke trials delivered their whole course in this window, 30 mL a day by infusion for 10 days.

  2. Days 10-21Clinical

    Community courses end at 10-20 days. The CARS rehabilitation trials ran 30 mL a day for the full 21 days alongside daily rehabilitation, and the CAPTAIN trials followed a 10-day 50 mL phase with two more 10-day cycles at 10 mL.

  3. Weeks 1-4 (dementia cycle)Clinical

    The labelled dementia regimen is 10-30 mL a day, five days a week, for four weeks. The 2006 dose-ranging trial extended this with twice-weekly infusions for a further eight weeks and found the lowest dose, 10 mL, the only one that improved cognition at week 24.

  4. BreakCommunity-reported

    Community guides describe a 1-2 month break and 2-3 courses a year; the label describes 2-4 dementia cycles a year. Guides frame the gap as the period in which effects keep developing, pointing to trials whose endpoints were measured at day 90 or later.

  5. Day 90 assessmentClinical

    Every major trial measured its primary endpoint 90 days after the first dose, long after the last injection: CASTA was neutral at that point, CARS and CAPTAIN II reported small-to-medium or large effects on function, and the Alzheimer's trials saw global change two months after the course ended.

  • The trials gave 30-50 mL a day by intravenous infusion to hospital patients with stroke, brain injury or dementia. The 5-10 mL intramuscular courses described by the nootropic community deliver a third to a tenth of that volume to healthy people, a use no trial has examined.
  • The 2023 Cochrane review found no reduction in death after acute stroke and more non-fatal serious adverse events, most pronounced with the 30 mL for 10 days regimen, while manufacturer-supported trials report functional benefit; the two readings of the same literature have not been reconciled, and the Cochrane review of vascular dementia rated its positive findings very low quality.
  • Cerebrolysin is not approved in the United States or the United Kingdom and the FDA orphan designations for frontotemporal dementia and CADASIL are not approvals. The label lists epilepsy, severe renal impairment and hypersensitivity as contraindications, and because it is a porcine protein hydrolysate its batch composition cannot be reduced to a single molecule.
Sources for this section (17)
  1. About Cerebrolysin: prescribing information based on the Austrian Summary of Product CharacteristicsEVER Neuro Pharma (cerebrolysin.com)2026Clinical
  2. How to use Cerebrolysin: Step-by-step guide (dosage recommendation and routes of administration)EVER Neuro Pharma (cerebrolysin.com)2026Clinical
  3. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trialStroke (PubMed)2012Clinical
  4. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter TrialStroke (PubMed)2016Clinical
  5. Safety and efficacy of Cerebrolysin in motor function recovery after stroke: a meta-analysis of the CARS trialsNeurological Sciences (PubMed)2017Clinical
  6. Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trialsNeurological Sciences (PubMed)2018Clinical
  7. Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I, a randomized, placebo-controlled, double-blind, Asian-Pacific trialNeurological Sciences (PubMed)2020Clinical
  8. Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trialNeurological Sciences (PubMed)2020Clinical
  9. Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial seriesNeurological Sciences (PubMed)2021Clinical
  10. A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's diseaseEuropean Journal of Neurology (PubMed)2006Clinical
  11. Cerebrolysin in Alzheimer's disease: a randomized, double-blind, placebo-controlled trial with a neurotrophic agentJournal of Neural Transmission (PubMed)2002Clinical
  12. Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trialsDementia and Geriatric Cognitive Disorders (PubMed)2015Clinical
  13. Cerebrolysin for acute ischaemic stroke (Cochrane Review, 2023 update)Cochrane Database of Systematic Reviews (PubMed)2023Clinical
  14. Cerebrolysin for vascular dementia (Cochrane Review)Cochrane Database of Systematic Reviews (PubMed)2019Clinical

Plus 3 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.

Overview

Cerebrolysin is a prescription injectable made by EVER Neuro Pharma in Austria from enzymatically broken-down porcine brain protein; each millilitre contains 215.2 mg of a mixture of low-molecular-weight peptides and free amino acids, which is why it has no single structure, is dosed in millilitres rather than milligrams, and has no PubChem compound record (PubChem holds only substance entries under its UNII 37KZM6S21G and CAS 12656-61-0, so the chemistry card is left empty). It is registered in Austria, Germany, Russia, China, South Korea and many other countries for stroke, traumatic brain injury and dementia, but not in the United States or the United Kingdom; the FDA has granted it orphan designations for frontotemporal dementia (2016) and CADASIL (2018) without approving it. It has a large trial literature with divided readings: a 2023 Cochrane review of seven acute ischaemic stroke trials found no effect on death and a rise in non-fatal serious adverse events, while manufacturer-supported trials in stroke rehabilitation (CARS) and traumatic brain injury (CAPTAIN) reported better motor and neuropsychological recovery when 30-50 mL daily courses were added to standard care. The nootropic community uses 5-10 mL intramuscular courses that sit below and outside the labelled regimens.

What researchers are exploring

These themes organize the educational information currently available. Individual claims remain under source review and are not treatment claims.

  • 1

    Constituent Neurotrophic Factors

    Key components and their biological roles

  • 2

    Clinical Research Highlights

    Findings across neurological indications

  • 3

    Pain & Sensory Studies

    Insights from migraine and neuropathic pain models

  • 4

    Summary

    Broad neurotrophic utility

What is known and what still needs verification

Available context is organized without assigning unsupported study models or evidence grades.

  • Not graded

    Constituent Neurotrophic Factors

    Key components and their biological roles

  • Not graded

    Clinical Research Highlights

    Findings across neurological indications

Identity, limitations and unknowns

Molecular profile

CAS Number
12656-61-0
Synonyms
Cerebrolyzin, FPE-1070, Renacenz, 37KZM6S21G

Important limitations

  • Individual claims and source links have not yet completed editorial verification.
  • Evidence level, applicable study model, formulation, route and population remain unassigned.

Sources

1 link carried over from the earlier page, awaiting verification.

  1. Source link (pmc.ncbi.nlm.nih.gov)Verification pendingNot graded