Cerebrolysin: stroke trials, harms and authorisation status

In short

Cerebrolysin is a mixture of peptides and amino acids made from pig brain proteins, with a marketing authorisation in nine EU countries but not in Finland [1]A [17]regulator. According to a Cochrane review it probably does not reduce deaths in acute ischaemic stroke [1]A.

• Cerebrolysin is given as an injection into a muscle or a vein, and according to the Austrian package leaflet it is given by a health professional [16]official [17]regulator.
• The largest ischaemic stroke trial (1,070 patients) found no difference from placebo on its primary outcome [2]A.
• Meta-analyses done with the manufacturer report benefit in early recovery [6]A, but according to the independent Cochrane review serious adverse events that did not lead to death may increase [1]A.
• In Finland Cerebrolysin has no marketing authorisation and is not on Fimea's medicines list; the list, however, is not exhaustive [17, 19]regulator.
• The WADA 2026 Prohibited List does not name Cerebrolysin [21]regulator.

What is Cerebrolysin?

Cerebrolysin is a mixture of low-molecular-weight peptides and amino acids derived from pig brain [1]A. According to the Austrian package leaflet it is a peptide preparation obtained from pig brain protein, intended to support brain function [16]official. It is therefore not one peptide but a mixture of many substances.

A Belgian laboratory analysed a Cerebrolysin sample obtained over the internet with mass spectrometry and identified 638 different peptides. Most came from proteins of the cell skeleton and of the insulating sheath of nerve cells (tubulin, actin and myelin basic protein) [14]D.

The manufacturer is the Austrian company EVER Neuro Pharma GmbH. In the EMA Article 57 data all 11 Cerebrolysin products are held by it, and they are given into a muscle or a vein [17]regulator. According to the Cochrane review Cerebrolysin is widely used to treat ischaemic stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries [1]A.

Basics: What are peptides?. All substances: Peptides A-Z.

Evidence at a glance

Each cell gives the type of study and the source. The letter is the level of evidence, not the result.

"-" = no such study is known.

What is Cerebrolysin used for?

In countries where it is authorised, Cerebrolysin is used as an add-on treatment for disorders of the brain's blood circulation. In Finland it has no approved indication, because there is no marketing authorisation [17]regulator.

• Approved indications in Austria. According to the package leaflet Cerebrolysin is used in adults and patients over 65 as supportive treatment of cerebrovascular disorders, in particular Alzheimer-type and vascular dementia, deficits after a stroke, and concussion and brain contusion [16]official.
• Route. The product is given as an injection into a muscle or a vein, larger volumes as an infusion into a vein. The treatment plan is set by a specialist, and the medicine is given by a doctor or nurse [16]official.
• Children. It is not recommended under 18 because there are too few data [16]official.
• Research use. Brain injury [12, 13]A, speech disorder after stroke [8]A and ischaemic stroke together with clot-dissolving treatment [3]A have been studied in randomised trials.

How does Cerebrolysin work?

How it works is not known precisely. The Cochrane review describes the mixture as having potential neuroprotective properties [1]A, and trial authors describe it as a neuroprotective and neurotrophic agent [5, 8]A.

A laboratory study found no fragments of known neurotrophic factors (GDNF, NGF, BDNF, CNTF) in a sample obtained over the internet. According to the authors the effects reported in the literature are likely due to new, as yet unknown peptides [14]D. Because the mixture contains hundreds of peptides, no single receptor or signalling pathway that would explain an effect has been shown.

In laboratory tests other brain preparations claimed to be similar to Cerebrolysin differed in composition from Cerebrolysin and had no relevant biological activity when their neurotrophic activity was measured [15]D.

Has Cerebrolysin been studied in humans?

Yes. There are randomised, placebo-controlled trials in ischaemic stroke, dementia and brain injury, and two Cochrane reviews [1, 9]A. The results conflict: the largest trial was negative [2]A, and some of the positive results come from trials in which the manufacturer took part as funder or author [1, 4]A.

Ischaemic stroke

• Cochrane review (2023). Seven trials, 1,773 patients. Cerebrolysin or a similar product probably made little or no difference to deaths (moderate certainty). No trial reported function as death or dependency. The manufacturer supported three multicentre trials [1]A.
• CASTA (2012). 1,070 patients in Asia; treatment started within 12 hours of symptom onset and was given into a vein for ten days. The combined primary outcome did not differ from placebo. In a post hoc analysis the most severely affected patients showed a trend in favour of Cerebrolysin, which according to the authors should be confirmed in a new trial [2]A.
• With clot-dissolving treatment (2013). 119 patients received Cerebrolysin or placebo on top of clot-dissolving treatment. The trial was stopped because there was no benefit in function at three months. During treatment neurological status improved more often in the Cerebrolysin group [3]A.
• Meta-analysis (2018). Pooling nine trials (1,879 patients), Cerebrolysin improved neurological status at one month compared with placebo, and adverse events were at placebo level [6]A. The authors include authors of the CARS trial [4, 6]A.

Rehabilitation after stroke

• CARS (2016). Patients received Cerebrolysin or placebo for three weeks alongside rehabilitation. An arm-function test at day 90 was clearly better in the Cerebrolysin group. The authors call the trial exploratory and small and say the result must be confirmed in a large trial. Three authors worked for the manufacturer [4]A.
• Korean trial (2016). 70 patients. Motor function improved in both groups, with no difference between them. Only in the subgroup with severe paralysis was Cerebrolysin better [5]A.
• Speech disorder, ESCAS (2025). 123 patients in two Romanian hospitals. Cerebrolysin added to speech therapy improved language test scores more than placebo. It was a pilot trial, and some authors have received fees from the manufacturer [8]A.
• Guideline (2021). A guideline of the European Academy of Neurology and the European Federation of Neurorehabilitation Societies recommends Cerebrolysin to support early rehabilitation after ischaemic stroke [7]. Its authors include researchers from the CARS trial and the meta-analysis [4, 6, 7].

Dementia

• Vascular dementia, Cochrane (2019). Six trials, 597 participants. Cognition and global function improved, but the evidence was of very low quality, the trials had a high risk of bias, and all trials that reported their funding were supported by the pharmaceutical industry. According to the authors any benefit may be too small to be clinically meaningful [9]A.
• Alzheimer's disease, meta-analysis (2015). Six placebo-controlled trials. Cognition was better at four weeks but no longer at six months; global change was better at both [10]A.
• Comparison with donepezil (2011). 197 patients. There were no significant group differences in cognition, daily functioning or behaviour. Global outcome favoured Cerebrolysin and the combination [11]A.

Brain injury

The CAPTAIN I trial had 46 patients. The primary outcome narrowly missed statistical significance in the intention-to-treat analysis, but was significant in the per-protocol analysis [12]A. In the pooled analysis of the two CAPTAIN trials (185 patients) the effect was small to medium at 30 and 90 days [13]A. The trials are small, and no large confirmatory trial has been published.

Healthy people

In a study published in 1998, 48 healthy men received placebo or Cerebrolysin as an infusion for ten days. During a model of reduced oxygen to the brain caused by overbreathing, word recall weakened in the placebo group but not in the Cerebrolysin groups. With the highest dose mild signs of overdose and a small drop in blood pressure were seen [24]A.

In a study published in 2000, healthy older people took a single dose by mouth. Alpha activity in the brain's electrical recording increased, and they made fewer errors in memory tasks than at baseline [25]B. Both studies measured changes over hours or days.

Who studies Cerebrolysin?

The manufacturer has taken part in many clinical trials: of the seven ischaemic stroke trials in the Cochrane review it supported three [1]A. Three authors of the CARS trial worked for the manufacturer EVER Neuro Pharma [4]A, and according to the conflict-of-interest statement of the ESCAS trial several authors have led trials funded by the manufacturer or received fees from it [8]A. The same researchers, for example Muresanu, Vester and Hömberg, recur in the stroke, brain injury and guideline work [4, 6, 7, 13].

Independent assessments include the Cochrane review of ischaemic stroke by Russian researchers [1]A and the Cochrane review of vascular dementia by Chinese researchers [9]A. The composition has been studied by a Belgian [14]D and an Austrian laboratory [15]D.

Author of this page: editorial team

This page was written by the Molecular Recovery editorial team. The draft was made with the help of AI, and the claims were checked against the sources (AI policy). The page has not been medically reviewed. How we work: About us.

What are the side effects of Cerebrolysin?

In most trials adverse events were as common as with placebo [1, 6]A. According to the independent Cochrane review, however, serious adverse events that did not lead to death probably increased in people given Cerebrolysin [1]A.

Adverse events in trials

In the Cochrane review there was little or no difference in the number of people with any adverse event (low certainty), and probably no difference in the total number with serious adverse events. Serious non-fatal adverse events, however, were more common with Cerebrolysin: risk ratio 2.39 in three trials with 1,335 patients (moderate certainty) [1]A. In trials and meta-analyses done with the manufacturer adverse events were at placebo level [4, 6, 10]A.

Side effects in the package leaflet

• Rare: agitation (aggression, confusion, insomnia), loss of appetite, dizziness and a feeling of heat or sweating when given too fast, and itching [16]official.
• Very rare: allergic reactions up to a shock-like state, single seizures, palpitations or heart rhythm disorders when given too fast, stomach complaints, and redness and itching at the injection site [16]official.
• Driving. According to the package leaflet the medicine can impair reactions, and patients should not drive during treatment [16]official.

Who should not use it. According to the package leaflet Cerebrolysin must not be used in people allergic to the product, during an epileptic seizure or in severe kidney impairment. Special care is needed in allergies and epilepsy, because seizures may become more frequent [16]official.

We found no studies on the harms of Cerebrolysin obtained online. According to Fimea an injected product may be a medicine in Finland, and an unauthorised product may contain a different substance than the package says [20]regulator. More: Side effects and safety.

Interactions and who lacks data

The Austrian package leaflet warns of interactions with antidepressants and MAO inhibitors. At high doses together with high doses of MAO inhibitors Cerebrolysin can raise blood pressure [16]official.

Cerebrolysin should not be given in the same infusion as balanced amino acid solutions, nor in the same syringe as vitamins or heart medicines [16]official.

On pregnancy and breastfeeding the package leaflet only advises asking a doctor or pharmacist [16]official. There are too few data on children [16]official.

What speaks against it and what is unknown

The largest and most independent evidence is negative or uncertain: the largest stroke trial was neutral [2]A, and according to the Cochrane review deaths probably do not change [1]A.

Counter-evidence

• In the CASTA trial of 1,070 ischaemic stroke patients the primary outcome did not differ from placebo [2]A.
• Cerebrolysin given with clot-dissolving treatment did not improve function at three months, and the trial was stopped [3]A.
• In the Korean rehabilitation trial there was no difference between the groups overall [5]A.
• According to the Cochrane review serious non-fatal adverse events probably increase [1]A.
• In vascular dementia the Cochrane review judged the evidence very weak and any benefit possibly too small to matter to patients [9]A.
• In Alzheimer's disease the cognitive benefit was no longer significant at six months [10]A.

Retracted animal studies

At least four papers that studied Cerebrolysin in mice were retracted in 2025-2026. They concerned mouse models of Alzheimer's disease, Rett syndrome and tau protein disorders [22, 26, 27, 28]E, not peer-reviewed. A retracted paper is not evidence, and no animal study has been used as evidence on this page.

What the evidence does not support

• "Cerebrolysin contains brain growth factors": a laboratory study found no fragments of known neurotrophic factors [14]D.
• "Cerebrolysin reduces deaths from ischaemic stroke": according to the Cochrane review it probably does not [1]A.
• "All peptide preparations made from brain are the same substance": composition and activity in cells differed [15]D.
• "Cerebrolysin improves memory in healthy people": there are only two small studies in healthy people, published in 1998-2000, which measured changes over hours or days [24]A [25]B. We found no study of long-term benefit in healthy people.

What is unknown

• Which of the hundreds of peptides in the mixture acts, if any [14]D.
• Whether Cerebrolysin improves long-term function. None of the trials in the Cochrane review reported death or dependency as a combined outcome [1]A.
• What repeated use does in the long run. The package leaflet describes repeated treatment courses in dementia [16]official, but of the vascular dementia trials only one reported mortality and none reported quality of life [9]A.
• What happens when treatment stops: we found no study of the effects of stopping.

Cerebrolysin dosing in studies

Cerebrolysin has no marketing authorisation and no approved dosing in Finland [17]regulator, so this site has no dose page or calculator for it. According to the Austrian package leaflet the treatment plan and dose are decided by a specialist, and the medicine is given by a health professional [16]official.

In the stroke trials Cerebrolysin was given once a day for 10-21 days, starting within three days of symptom onset [4, 6]A. In the CASTA trial it was given as an infusion into a vein [2]A. In the brain injury trials the first course was followed by two further courses [12, 13]A. These are study designs, not recommendations.

Cerebrolysin vs Cortexin and other brain preparations: what is the difference?

Cerebrolysin is made from pig brain. The 2023 Cochrane review also included Cortexin, a Cerebrolysin-like peptide mixture made from cattle brain, and assessed the two together [1]A.

In a laboratory comparison several peptide preparations claimed to be similar to Cerebrolysin, and approved in some countries, clearly differed in composition from Cerebrolysin and had no relevant biological activity in cells [15]D. The products cannot therefore be treated as the same substance, even if they are made from brain tissue.

Combinations: Cerebrolysin with other treatments

Cerebrolysin has been studied as an add-on to other treatments, not as a replacement on its own.

• Clot-dissolving treatment (alteplase). The combination was safe, but function at three months did not improve [3]A.
• Rehabilitation and speech therapy. CARS and ESCAS reported benefit [4, 8]A, the Korean trial only in the most severely paralysed [5]A.
• Donepezil in Alzheimer's disease. The combination was safe, but there were no significant group differences in cognition [11]A.

Is Cerebrolysin legal in Finland?

Cerebrolysin has no marketing authorisation in Finland: the EMA Article 57 data of 9 October 2026 list no Finnish authorisation [17]regulator.

• Authorisations elsewhere. There are national authorisations in Austria, Bulgaria, Croatia, Latvia, Lithuania, Poland, Romania, Slovakia and the Czech Republic. Austria has three products, named Cerebrolysin, Ambotonin and Cerebrotonin, all Cerebrolysin concentrate [17]regulator.
• No central EU authorisation. The EMA data on centrally authorised medicines (14 October 2026) contain no Cerebrolysin [18]regulator.
• Medicines list. Cerebrolysin is not in annex 1 or 1 A of Fimea's medicines list. The list states that it is not exhaustive: substances not named that meet the definition of a medicine in the Medicines Act are medicines [19]regulator.
• Prescribed in Austria. According to the package leaflet the medicine has been prescribed for the patient personally and must not be passed on to others [16]official.
• Fimea warning of 29 June 2026. According to Fimea a product injected through the skin may be a medicine in Finland, medicines should be obtained only from legal sources, and there are restrictions on importing medicines and receiving them by post from abroad [20]regulator.

Overview of the law: peptides and the law in Finland. Bringing products back from travel: Travelling with peptides.

This is not legal advice. Disclaimer.

How is the quality of a Cerebrolysin product assessed?

An authorised product is the only way to know what is in the ampoule. Cerebrolysin is a mixture of hundreds of peptides [14]D, so a certificate of analysis (COA) that measures the content of a single substance does not describe the whole composition.

Other preparations made from brain tissue did not match Cerebrolysin in laboratory tests [15]D. According to Fimea an unauthorised product sold online may contain a different substance than the package says [20]regulator. More: How to read a COA and check a test result.

The future: what comes next?

On 15 October 2026 ClinicalTrials.gov listed eight ongoing or upcoming Cerebrolysin studies [23]E, not peer-reviewed. They concern, among others, an inherited disease of the small brain vessels (CADASIL, a manufacturer study), bleeding into the brain, prolonged disorders of consciousness, facial nerve palsy, speech disorder after stroke, and treatment after a blocked vessel has been reopened [23]E, not peer-reviewed.

Registration is not a result. Authors of several earlier positive trials have called for large confirmatory trials [2, 4, 8, 12]A.

FAQ

Read the research yourself: sources

Every source opens the original publication or the regulator's page. The level shows what the source itself reports.

1. Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023;10(10):CD007026. PMID 37818733 A
2. Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z; CASTA Investigators. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial. Stroke. 2012;43(3):630-636. PMID 22282884 A
3. Lang W, Stadler CH, Poljakovic Z, Fleet D; Lyse Study Group. A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke. Int J Stroke. 2013;8(2):95-104. PMID 23009193 A
4. Muresanu DF, Heiss WD, Hoemberg V, et al. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016;47(1):151-159. PMID 26564102 A
5. Chang WH, Park CH, Kim DY, et al. Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke. BMC Neurol. 2016;16:31. PMID 26934986 A
6. Bornstein NM, Guekht A, Vester J, et al. Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials. Neurol Sci. 2018;39(4):629-640. PMID 29248999 A
7. Beghi E, Binder H, Birle C, et al. European Academy of Neurology and European Federation of Neurorehabilitation Societies guideline on pharmacological support in early motor rehabilitation after acute ischaemic stroke. Eur J Neurol. 2021;28(9):2831-2845. PMID 34152062 (review)
8. Homberg V, Jianu DC, Stan A, et al. Speech Therapy Combined With Cerebrolysin in Enhancing Nonfluent Aphasia Recovery After Acute Ischemic Stroke: ESCAS Randomized Pilot Study. Stroke. 2025;56(4):937-947. PMID 39957612 A
9. Cui S, Chen N, Yang M, et al. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019;2019(11):CD008900. PMID 31710397 A
10. Gauthier S, Proaño JV, Jia J, Froelich L, Vester JC, Doppler E. Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials. Dement Geriatr Cogn Disord. 2015;39(5-6):332-347. PMID 25832905 A
11. Alvarez XA, Cacabelos R, Sampedro C, et al. Combination treatment in Alzheimer's disease: results of a randomized, controlled trial with cerebrolysin and donepezil. Curr Alzheimer Res. 2011;8(5):583-591. PMID 21679156 A
12. Poon W, Matula C, Vos PE, et al. Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I, a randomized, placebo-controlled, double-blind, Asian-Pacific trial. Neurol Sci. 2020;41(2):281-293. PMID 31494820 A
13. Vester JC, Buzoianu AD, Florian SI, et al. Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series. Neurol Sci. 2021;42(11):4531-4541. PMID 33620612 A
14. Gevaert B, D'Hondt M, Bracke N, et al. Peptide profiling of Internet-obtained Cerebrolysin using high performance liquid chromatography - electrospray ionization ion trap and ultra high performance liquid chromatography - ion mobility - quadrupole time of flight mass spectrometry. Drug Test Anal. 2015;7(9):835-842. PMID 26017115 D
15. Seidl LF, Aigner L. Comparing the biological activity and composition of Cerebrolysin with other peptide preparations. J Med Life. 2024;17(1):24-27. PMID 38737662 D
16. BASG (Austrian Federal Office for Safety in Health Care), medicines register. Cerebrolysin - parenterale Lösung, Gebrauchsinformation (package leaflet), EVER Neuro Pharma GmbH, revised March 2021. BASG official
17. European Medicines Agency. Article 57 product data (EMA/518502/2018 Rev.90, data as of 9 Oct 2026): 11 Cerebrolysin concentrate products in 9 countries, none in Finland. EMA regulator
18. European Medicines Agency. Medicine data (centrally authorised medicines, data set of 14 Oct 2026): no product with Cerebrolysin. EMA regulator
19. Finland. Lääkeluettelo (Fimea medicines list), decision 230/2025, section 1 and annexes 1 and 1 A. Finlex regulator
20. Fimea. Fimea varoittaa: älä käytä verkosta ostettuja pistettäviä peptidejä / Fimea warns: do not use injectable peptides purchased online. 29 Jun 2026. Fimea regulator
21. World Anti-Doping Agency. 2026 Prohibited List (sections S0 and S2; Cerebrolysin is not named). WADA regulator
22. Rockenstein E, Ubhi K, Mante M, et al. Retraction Note: Neuroprotective effects of Cerebrolysin in triple repeat Tau transgenic model of Pick's disease and fronto-temporal tauopathies. BMC Neurosci. 2025;26(1):23. PMID 40065222 E, not peer-reviewed
23. Funke M, Fiehler J, Mewes I, Eiselt M, Rother I, Windisch M. Dose-dependent effects of Cerebrolysin on EEG and short-term memory of healthy volunteers during control and hyperventilation induced cerebral ischemia. J Neural Transm Suppl. 1998;53:385-398. PMID 9700674 A
24. Alvarez XA, Lombardi VR, Corzo L, et al. Oral Cerebrolysin enhances brain alpha activity and improves cognitive performance in elderly control subjects. J Neural Transm Suppl. 2000;59:315-328. PMID 10961443 B
25. ClinicalTrials.gov. Studies with the intervention Cerebrolysin, status recruiting, not yet recruiting or active, searched 15 Oct 2026: 8 studies. ClinicalTrials.gov E, not peer-reviewed
26. Rockenstein E, Ubhi K, Trejo M, et al. Retraction Note: Cerebrolysin efficacy in a transgenic model of tauopathy: role in regulation of mitochondrial structure. BMC Neurosci. 2025;26(1):67. PMID 41382024 E, not peer-reviewed
27. Retraction: Regional Comparison of the Neurogenic Effects of CNTF-Derived Peptides and Cerebrolysin in AβPP Transgenic Mice. J Alzheimers Dis. 2026;111(4):1893. PMID 42015030 E, not peer-reviewed
28. Doppler E, Rockenstein E, Ubhi K, et al. Retraction Note: Neurotrophic effects of Cerebrolysin in the Mecp2(308/Y) transgenic model of Rett syndrome. Acta Neuropathol. 2026;151(1):30. PMID 41874695 E, not peer-reviewed

Sources searched and read on 15 Oct 2026: PubMed abstracts, the EMA Article 57 data and medicine data, the Austrian medicines agency package leaflet, Fimea's medicines list, ClinicalTrials.gov and the WADA 2026 Prohibited List (local text copy). The Fimea warning was read from a saved copy. Study details are from the abstracts.

Evidence levels: A = randomised human trial or meta-analysis · B = observational human study or case series · C = animal study · D = cell or laboratory study · E = not peer-reviewed · regulator = a regulator's assessment or decision, not research evidence. The marker official means official product information (summary of product characteristics or label); it is not research evidence. For a review, the level shows what kind of research the statement rests on. No level: statements that something has not been studied, reviews' interpretations, named hypotheses and the general rules in our certificate-of-analysis guide.

Content is general information about research, not medical advice. If you have symptoms, contact a healthcare professional.