Cerebrolysin

Origin and composition

Cerebrolysin is not a single peptide. It is made by the controlled digestion of proteins from pig brain, which leaves a mixture of short peptides and free amino acids. The licensed solution contains 215.2 mg of this 'Cerebrolysin concentrate' per mL, with only sodium hydroxide and water for injection added. Because it is defined by its source and its manufacturing process, it has no single amino-acid sequence, molecular formula or molar mass.

The marketing authorisation holder is EVER Neuro Pharma in Unterach, Austria. The medicine is an amber solution in ampoules of 1 to 10 mL, given by intramuscular or intravenous injection or, diluted, as an intravenous infusion. In Poland it has been authorised since 2000. The 2023 Cochrane review describes it as widely used for stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries.

How it is thought to work

The manufacturer describes Cerebrolysin as acting like the brain's own neurotrophic factors, the proteins that keep nerve cells alive and help them form new connections. The support for that comes from cell and animal studies. According to the product information, it improved learning in animals and, in models of reduced blood flow to the brain, shrank the area of dead tissue and reduced swelling.

Which components do this is not known. In 2015 a team at Ghent University analysed a sample bought online and identified 638 different peptides, mostly fragments of structural proteins such as tubulin, actin and myelin basic protein; they found no fragments of known growth factors such as BDNF, NGF, GDNF or CNTF. The product information adds that the way the body absorbs and clears the mixture could not be measured directly. That its activity can be detected in plasma for up to 24 hours, and that components reach the brain, is inferred indirectly, partly from animal experiments.

Is Cerebrolysin approved?

In nine EU countries, yes, as a prescription medicine. There is no EU-wide authorisation, and in the Netherlands and the US it is not approved.

Research-grade material sold as Cerebrolysin is not this medicine. It has no marketing authorisation and may not be used in people.

• EU: the EMA has no assessment report on Cerebrolysin. Its database of nationally authorised medicines (data of 9 October 2026) lists the product of EVER Neuro Pharma in Austria, Bulgaria, Croatia, Czechia, Latvia, Lithuania, Poland, Romania and Slovakia. In the Polish product information it is indicated as an add-on treatment for Alzheimer-type and vascular dementia, for deficits after a stroke, and for concussion and brain contusion.
• Netherlands: not authorised. The same database has no Dutch, Belgian or German entry for it.
• US: not approved. EVER Pharma itself states that Cerebrolysin is not registered with the FDA and not approved for sale or distribution in the United States.

What the research shows

The best-known trials were run in Asia and Eastern Europe, several of them funded or supported by the manufacturer. Analyses led by the trial investigators tend to be positive; the independent Cochrane reviews are far more cautious. The main results:

• Acute ischaemic stroke, Cochrane 2023: seven randomised trials with 1,773 participants, one of them (272 participants) testing Cortexin, a similar product from cattle brain. Treatment probably made little or no difference to deaths (risk ratio 0.96, 95% CI 0.65 to 1.41; 6 trials, 1,689 participants). The total number of people with a serious adverse event did not differ clearly (risk ratio 1.16), but non-fatal serious adverse events were more common (risk ratio 2.39, 95% CI 1.10 to 5.23; 3 trials, 1,335 participants). None of the trials reported death or dependence at the end of follow-up; every Cerebrolysin trial had an unclear risk of selective reporting, and the manufacturer supported three of them.
• CASTA (Stroke 2012, NCT00868283): 1,070 patients in Asia, randomised within 12 hours of a stroke to ten days of infusions or placebo. The primary endpoint showed no difference; a post hoc analysis suggested a trend in favour of Cerebrolysin in severe strokes.
• CARS (Stroke 2016, funded by EVER Neuro Pharma): 208 patients in Romania, Ukraine and Poland, treated for 21 days from 24 to 72 hours after the stroke alongside a rehabilitation programme. Arm function at day 90 was better than on placebo (Mann-Whitney effect size 0.71); the authors called the trial exploratory and said the results should be confirmed in a large trial.
• Guideline: in 2021 the European Academy of Neurology and the European Federation of Neurorehabilitation Societies recommended Cerebrolysin, alongside citalopram, to support early motor rehabilitation after an ischaemic stroke. Several of the guideline's authors were also authors of CARS or CASTA.
• Traumatic brain injury: the CAPTAIN I and II trials together included 185 patients with moderate to severe injuries. On a combined set of functional and neuropsychological scales, the pooled analysis found a small-to-medium effect at day 30 and day 90 (Mann-Whitney 0.60), with safety similar to placebo.
• Vascular dementia, Cochrane 2019: six trials with 597 participants. Cognition (standardised mean difference 0.36; 3 trials, 420 people) and overall clinical response (risk ratio 2.69; 2 trials, 379 people) favoured Cerebrolysin, but the evidence was of very low quality, the trials had a high risk of bias, and the reviewers judged that any benefit may be too small to matter clinically. No new trial had appeared since the previous version of the review in 2013.
• All types of dementia, systematic review 2021: across eight trials with 793 participants, cognition improved slightly (standardised mean difference −0.16) and serious adverse events did not differ (6 trials, 1,014 participants). Certainty was low to very low, and the authors judged the effects probably smaller than would be clinically relevant.

Side effects and warnings

The Polish product information lists no side effect as common. Rare: loss of appetite, agitation (aggression, confusion, sleeplessness), itching, and dizziness or a feeling of heat and sweating when it is injected too fast. Very rare: allergic reactions, ranging from itching, headache and fever to breathlessness and a shock-like state; grand mal seizures and convulsions; palpitations or an irregular heartbeat when injected too fast; stomach and bowel complaints; and redness or burning at the injection site.

It must not be used in epilepsy, especially with grand mal seizures, because it can make seizures more frequent, nor in severe kidney failure or hypersensitivity to the product. The label asks for care in people with allergic disease and in combination with antidepressants or MAO inhibitors, whose effect it may add to, and says there are no human data on use in pregnancy or breastfeeding.

In trials, the share of people with any adverse event was similar to placebo, both in the stroke trials pooled by Cochrane (risk ratio 1.03; 4 trials, 1,607 participants) and in dementia. The signal that stands out is the higher rate of non-fatal serious adverse events in acute stroke.

Similar products and research powders

Other brain-derived peptide products exist. The 2023 Cochrane stroke review included one trial of Cortexin, made from cattle brain, as a 'Cerebrolysin-like agent'. Because it comes from a different animal, it is a different mixture, not a copy.

Powders sold online as 'Cerebrolysin' for research are not the licensed solution. The medicine is defined by its source and manufacturing process and is measured in millilitres of a 215.2 mg/mL solution; a powder labelled in milligrams is a different product. And because the substance is a mixture of hundreds of peptides, there is no single sequence or mass against which a laboratory can confirm its identity, as it can for a synthetic peptide.

Frequently asked questions

What is Cerebrolysin made of?

Proteins from pig brain that are broken down in a controlled way into short peptides and free amino acids. The licensed solution contains 215.2 mg of this concentrate per mL. It has no fixed formula: a 2015 analysis of one sample identified 638 different peptides, mostly fragments of structural brain proteins, and no fragments of known growth factors such as BDNF or NGF.

Is Cerebrolysin legal in the Netherlands?

It is not authorised as a medicine in the Netherlands. The EMA's database of nationally authorised medicines lists it in nine other EU countries, including Austria, Poland and Romania, where it is a prescription medicine, but not in the Netherlands, Belgium or Germany. Research-grade material sold under the name is not a medicine and may not be used in people.

Does Cerebrolysin work after a stroke?

That is disputed. Manufacturer-funded trials such as CARS (208 patients) found better arm function, and a 2021 European neurology guideline recommends it for early motor rehabilitation. The independent Cochrane review of 2023 (1,773 participants) found no effect on deaths and more non-fatal serious adverse events, and none of its trials reported death or dependence; the largest randomised trial, CASTA (1,070 patients), missed its primary endpoint.

Is Cerebrolysin banned in sport?

Cerebrolysin is not named on WADA's Prohibited List for 2026, nor on the 2027 list that applies from 1 January 2027. The catch-all class S0 does not cover it, because S0 is limited to substances without a current approval for human use anywhere. The list does not say whether the open-ended growth-factor clause in S2.3 could apply to it.

Why is it authorised in some EU countries but not by the EMA?

Many medicines in the EU are authorised country by country rather than through the EMA. Cerebrolysin holds national authorisations in nine member states (in Poland since 2000), granted by those countries' own regulators. There is no EU-wide authorisation and no EMA assessment report, so the EMA has not published any judgement on its benefits and risks.

Is research-grade Cerebrolysin the same as the medicine?

No. The medicine is a solution for injection in ampoules, made by EVER Neuro Pharma under a marketing authorisation and measured in millilitres of a 215.2 mg/mL solution. A powder sold for research under the same name is a different product without an authorisation, and because Cerebrolysin is a mixture of hundreds of peptides, there is no single sequence or mass that shows it matches the medicine. It may not be used in people. Our lab results show what we test for.

Storage and handling

Store according to product-label instructions and batch handling notes. Lyophilized research peptides are commonly kept dry, protected from light, and handled with clean laboratory technique.

References

Checked against these sources on 28 October 2026.