Cerebrolysin
A pig-brain peptide mixture used for stroke and dementia in about 50 countries: many trials, and Cochrane reviews that found no survival benefit
Cerebrolysin is not a single molecule but a mixture of small peptides and amino acids made from pig brain, given by intravenous infusion. It is approved in Austria and about 50 other countries and has a long list of controlled trials in stroke and dementia. The independent summaries are sobering: the 2023 Cochrane review found no effect on death after stroke and more non-fatal serious adverse events, and the Cochrane review of vascular dementia judged its evidence weak.
What is it?
Cerebrolysin is a mixture of low-molecular-weight peptides and free amino acids derived from pig brain, so it has no single sequence, formula or molecular weight. Known in early papers as FPF-1070 and made by EVER Neuro Pharma (formerly Ebewe Pharma), it is approved in Austria and about 50 other countries and used widely for stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries. It is given as a course of daily infusions, typically 10 to 30 mL a day for one to four weeks.
In stroke, the largest trial was neutral. CASTA randomised 1,070 Asian patients within 12 hours of stroke to 30 mL a day or placebo for 10 days and found no difference on its combined primary outcome; a post-hoc look at the most severe strokes showed a favourable trend. Smaller trials that paired the drug with early rehabilitation reported benefits, CARS a large effect on arm function at day 90. The 2023 Cochrane review pooled seven trials with 1,773 participants: little to no difference in death (risk ratio 0.96), but more people with non-fatal serious adverse events (risk ratio 2.39). The manufacturer supported three of the multicentre trials, and much of the risk of bias was unclear.
In dementia the trial results look better than the reviews. In 242 patients with vascular dementia, ADAS-cog+ scores improved by 10.6 points against 4.4 on placebo, and a dose-finding study in Alzheimer's disease improved global function at all three doses. But in a 197-patient Alzheimer's trial, neither cerebrolysin nor its combination with donepezil differed from donepezil alone on cognition, function or behaviour, and the 2019 Cochrane review of vascular dementia concluded that any benefit may be too small to matter and that the evidence base is weak.
Most reported side effects are mild: vertigo, agitation and feeling hot top a 2012 safety review, which found adverse-event rates similar to placebo in controlled trials. The Cochrane signal on non-fatal serious adverse events is the exception worth weighing, and it was clearest at 30 mL a day for 10 days. One odd finding: five older patients in a 2022 case series saw grey scalp hair darken during treatment. Cerebrolysin is not approved in the US and appears in no category on FDA's 503A list.
Mechanism of Action
Cerebrolysin is described as mimicking neurotrophic factors, but as a mixture it has no single target, and the mechanism evidence is thin next to the trial record. Four threads appear in the abstracts.
Neurotrophic-like action
Trial and review abstracts describe it as a neuropeptide preparation that mimics the effects of the body's neurotrophic factors, promoting neurogenesis and neuronal plasticity. That is a description of intent; none of the carded trials measured a neurotrophic effect in patients.
New neurons after stroke in rats
In rats with an embolic stroke, 2.5 or 5 mL/kg started 24 hours afterwards increased neural progenitor cells and migrating neuroblasts in the injured hemisphere at 28 days and reduced the number of dying cells.
Alongside other treatments
A 2012 safety review found it apparently safe with the clot-dissolving drug alteplase and with the dementia drugs donepezil and rivastigmine. In an Alzheimer's trial, adding it to donepezil favoured global outcome but did not improve cognition, function or behaviour.
Pigment cells
In five older patients whose grey scalp hair darkened during treatment, staining linked the change to reactivated melanocytes expressing MART-1/Melan-A. It is one small case series, and the mechanism is unexplained.
Published Research
Our evidence set holds 50 papers on cerebrolysin, 48 naming it in the title, and unusually for this encyclopedia most are human: randomised trials in stroke and dementia, and a run of Cochrane reviews. The 12 cards below lead with the largest trial and the independent reviews, negative findings included, then the smaller trials, a safety review, a case series and one animal study.
CASTA: acute stroke, 1,070 patients
Patients with acute ischaemic stroke in Asia were randomised within 12 hours to 30 mL of cerebrolysin or saline daily by infusion for 10 days, on top of aspirin. The combined primary outcome at 90 days showed no difference. In a post-hoc subgroup with severe strokes (NIHSS above 12), outcomes trended in favour of cerebrolysin and 90-day mortality was 10.5% versus 20.2%.
Cochrane 2023: acute ischaemic stroke
Seven randomised trials (1,773 participants) found little to no difference in all-cause death (risk ratio 0.96, 95% CI 0.65 to 1.41) or in total serious adverse events, but more people with non-fatal serious adverse events (risk ratio 2.39, 95% CI 1.10 to 5.23), most clearly at 30 mL for 10 days (2.87). The manufacturer supported three multicentre trials; risk of bias was largely unclear.
Cochrane 2017: what cerebrolysin is
The 2017 edition of the Cochrane stroke review describes cerebrolysin as a mixture of low-molecular-weight peptides and amino acids from pig brain tissue, widely used for acute stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries, and records that its authors contacted the maker, EVER Neuro Pharma (formerly Ebewe Pharma). The 2023 update, above, supersedes it.
CARS: stroke rehabilitation
Patients received 30 mL a day or saline for 21 days, starting 24 to 72 hours after stroke, alongside a standardised rehabilitation programme. Arm function on the Action Research Arm Test at day 90 showed a large effect in favour of cerebrolysin (Mann-Whitney estimator 0.71), and a small-to-medium effect across 12 outcome scales; 3.8% stopped early.
Early recovery after stroke, 100 patients
Patients enrolled within 18 hours of stroke received 30 mL a day for seven days, then 10 mL a day to day 30, or placebo. Change on the NIH Stroke Scale at day 30 favoured cerebrolysin with a medium-to-large effect (Mann-Whitney 0.66, 95% CI 0.55 to 0.78, P = 0.005), with similar effects on the modified Rankin Scale.
Vascular dementia, 242 patients
Added to aspirin, 20 mL of intravenous cerebrolysin daily in two treatment cycles improved ADAS-cog+ by 10.6 points at week 24, against 4.4 points on placebo (difference −6.17, P < .0001), and improved the clinician's global rating by a treatment difference of 0.84 (P < .0001).
Alzheimer's disease, three doses
In a dose-finding study, patients with Alzheimer's disease received 10, 30 or 60 mL infusions or saline over 12 weeks. At week 24 all three doses improved global clinical function, with gains in cognition, initiation of daily activities and neuropsychiatric symptoms at particular doses; total daily-living scores, MMSE and the trail-making test did not change significantly.
With donepezil in Alzheimer's disease
In a double-blind trial, 197 patients with mild-to-moderate Alzheimer's disease received cerebrolysin 10 mL, donepezil 10 mg, or both. At week 28 there were no significant group differences in cognition, function or behaviour; global outcome favoured cerebrolysin and the combination.
Cochrane 2019: vascular dementia
Courses of intravenous cerebrolysin improved cognition and general function in vascular dementia, but heterogeneity and high risk of bias limited the analysis, and the reviewers warn that any benefit may be too small to be clinically meaningful. No new trials had appeared since the previous review; they call the evidence base weak.
Safety profile from dementia and stroke trials
Adverse reactions were generally mild and transient, most often vertigo, agitation and feeling hot, and in the controlled trials analysed the incidence of adverse events was similar with cerebrolysin and placebo. It appeared safe with alteplase and with donepezil or rivastigmine, without major changes in vital signs or laboratory values.
Grey hair darkening: five patients
Five patients with an average age of 70.6, treated with cerebrolysin for neurological disease, had diffuse repigmentation of age-related grey scalp hair. Staining linked the darkening to reactivated melanocytes expressing MART-1/Melan-A. It is a case series, not a trial.
Neurogenesis after stroke in rats
In rats with an embolic middle cerebral artery stroke, cerebrolysin at 2.5 or 5 mL/kg, started 24 hours afterwards, increased neural progenitor cells in the subventricular zone and migrating neuroblasts at the edge of the damage at 28 days, and reduced cell death.
Dosing Data
Cerebrolysin is dosed by volume rather than milligrams, because it is a mixture. The trials gave 10 to 60 mL a day by intravenous infusion, in courses of one to four weeks.
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Side Effects & Contraindications
Reported Side Effects
The trials and a 2012 safety review describe mostly mild effects; the pooled Cochrane data add one signal the individual trials did not show.
Contraindications & Cautions
No study on this page sets contraindications. These cautions follow from the reviews and from what the product is.
Legal Status
Cerebrolysin is approved in Austria and about 50 other countries, not in the US. Status as of September 26, 2026.
Frequently Asked Questions
?Is cerebrolysin a peptide?
It is a mixture of many small peptides and free amino acids made from pig brain, not a single peptide. That is why it has no formula or molecular weight, and why it is dosed in millilitres rather than milligrams.
?Does cerebrolysin help after a stroke?
The largest trial, CASTA with 1,070 patients, found no difference on its primary outcome. Smaller trials combining it with early rehabilitation reported better function. The 2023 Cochrane review of seven trials found no effect on death and more non-fatal serious adverse events.
?Does it help dementia?
Trials in vascular dementia and Alzheimer's disease reported gains on cognitive and global scales, but a 197-patient Alzheimer's trial found no advantage over donepezil on cognition, function or behaviour, and the 2019 Cochrane review of vascular dementia called the evidence weak and the benefit possibly too small to matter.
?Is cerebrolysin safe?
Individual trials and a 2012 safety review report mostly mild effects, such as vertigo, agitation and feeling hot, at rates similar to placebo. The 2023 Cochrane review, pooling three trials, found more non-fatal serious adverse events with cerebrolysin, most clearly at 30 mL a day for 10 days.
?Is cerebrolysin available in the US?
It is not FDA-approved, and it appears in no category on FDA's 503A list, so US pharmacies cannot compound it. Status as of September 26, 2026.
?Can cerebrolysin darken grey hair?
A 2022 case series described five older patients whose grey scalp hair darkened during treatment, with signs of reactivated pigment cells. It is a single small report, and nobody has tested it as a hair treatment.
References
- [clinical-trial] Heiss WD, et al. "Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial." Stroke, 2012;43(3):630-6. PMID: 22282884.
- [review] Ziganshina LE, et al. "Cerebrolysin for acute ischaemic stroke." Cochrane Database Syst Rev, 2023;10(10):CD007026. PMID: 37818733.
- [review] Ziganshina LE, et al. "Cerebrolysin for acute ischaemic stroke." Cochrane Database Syst Rev, 2017;4(4):CD007026. PMID: 28430363.
- [pubmed] Muresanu DF, et al. "Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial." Stroke, 2016;47(1):151-9. PMID: 26564102.
- [pubmed] Gharagozli K, et al. "Efficacy and safety of Cerebrolysin treatment in early recovery after acute ischemic stroke: a randomized, placebo-controlled, double-blinded, multicenter clinical trial." J Med Life, 2017;10(3):153-160. PMID: 29075343.
- [pubmed] Guekht AB, et al. "Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial." J Stroke Cerebrovasc Dis, 2011;20(4):310-8. PMID: 20656516.
- [pubmed] Alvarez XA, et al. "Efficacy and safety of Cerebrolysin in moderate to moderately severe Alzheimer's disease: results of a randomized, double-blind, controlled trial investigating three dosages of Cerebrolysin." Eur J Neurol, 2011;18(1):59-68. PMID: 20500802.
- [clinical-trial] Alvarez XA, et al. "Combination treatment in Alzheimer's disease: results of a randomized, controlled trial with cerebrolysin and donepezil." Curr Alzheimer Res, 2011;8(5):583-91. PMID: 21679156.
- [review] Cui S, et al. "Cerebrolysin for vascular dementia." Cochrane Database Syst Rev, 2019;2019(11). PMID: 31710397.
- [review] Thome J, et al. "Safety profile of Cerebrolysin: clinical experience from dementia and stroke trials." Drugs Today (Barc), 2012;48 Suppl A:63-9. PMID: 22514795.
- [pubmed] Villarreal-Reyna G, et al. "Cerebrolysin induces hair repigmentation associated to MART-1/Melan-A reactivation." Eur J Med Res, 2022;27(1):257. PMID: 36411485.
- [pubmed] Zhang C, et al. "Cerebrolysin enhances neurogenesis in the ischemic brain and improves functional outcome after stroke." J Neurosci Res, 2010;88(15):3275-81. PMID: 20857512.
Sources & Citations
Every PMID on this page is PubMed-indexed and has been checked against its record. Both Cochrane stroke reviews are carded, the 2017 edition and its 2023 update, because our dataset cites the earlier one. Grey Peptides sells nothing and links to no vendor.
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