Cerebrolysin

What is Cerebrolysin, and where is it licensed?

According to the Summary of Product Characteristics published by the Austrian medicines authority (BASG), each milliliter of the product contains 215.2 mg of a proteolytic peptide fraction obtained from porcine brain protein. The product is a solution given into a vein or muscle, dispensed by prescription and only in pharmacies; the Austrian license is dated March 25, 1996. ^[1]

In the product information, the indication is written as “supportive treatment of cerebrovascular disorders,” and in particular Alzheimer-type dementia and vascular dementia, post-stroke deficits, and head injury (concussion and contusion of the brain) are listed. The product is used in adults and people over 65; it is not recommended under 18 because of insufficient data. ^[1] These indications are for diseases; enhancing mental performance in healthy people is not a licensed use.

The product information states that the substance consists of short-chain peptides similar or identical to those naturally found in the body, so its pharmacokinetic values cannot be measured directly. The findings on learning, synaptic plasticity, infarct volume, and brain edema in the mechanism-of-action section come from animal models. ^[1] Marketing phrases such as “repairs the brain” or “regenerates neurons” transfer these experimental findings to humans.

The Cochrane authors describe the product as “a mixture of low-molecular-weight peptides and amino acids obtained from porcine brain” and write that it is widely used in acute ischemic stroke in Russia, Eastern Europe, China, and other Asian and former Soviet countries. ^[2]

What does the independent Cochrane review say about acute stroke?

The Cochrane 2023 update includes 7 RCTs (1,773 participants) comparing Cerebrolysin or similar peptide mixtures started within the first 48 hours of stroke with placebo or no treatment; one of them was done with a similar product obtained from bovine brain. The authors judged the risk of bias in most studies to be unclear or high for randomization, concealment, and missing data; the manufacturer of Cerebrolysin supported three multicenter studies fully or by providing the drug, placebo, randomization codes, a research grant, or a statistician. ^[2]

Source: Cochrane 2023. ^[2] None of the studies included in the review reported a poor functional outcome in the form of “death or dependency,” which is the key measure in stroke trials, nor early death, quality of life, or time to return to work. The authors’ conclusion is that moderate-certainty evidence shows probably no benefit in preventing all-cause death and a possible increase in non-fatal serious adverse events. ^[2]

What did the manufacturer-linked meta-analysis find?

A 2018 meta-analysis using a different method pooled 9 RCTs started within the first 72 hours of stroke; individual patient data were used in five studies. For the day-30 NIHSS (stroke severity scale), the nonparametric Mann-Whitney effect size was 0.60 (95% CI 0.56–0.64; P<0.0001; 1,879 patients), and the number needed to treat for a clinically meaningful NIHSS change was calculated as 7.7 (95% CI 5.2–15.0). In 314 patients with a baseline NIHSS above 12 (moderate-to-severe stroke), the effect size for the modified Rankin scale at day 90 was 0.61 (95% CI 0.52–0.69). The authors report that safety was comparable with placebo. ^[3]

The methods section of this meta-analysis states that the manufacturer helped in finding additional resources. ^[3] The Cochrane review, by contrast, includes only studies started within the first 48 hours, looks at hard outcomes such as death and “death or dependency,” and finds no benefit on death. ^[2] The two assessments look at different measures: a small improvement in early neurological scores does not mean a reduction in death or long-term dependency.

How strong is the evidence in dementia?

The 2019 update of the Cochrane review for vascular dementia evaluated six RCTs with 597 participants; no eligible new studies were found after 2013. Five of the studies were done in China (three), Russia, and Romania; all three studies with funding information were supported by the pharmaceutical industry. ^[4]

• Cognition: 3 studies, 420 people; standardized mean difference 0.36 (95% CI 0.13–0.58), very low-quality evidence.
• Global clinical function: 2 studies, 379 people; response rate RR 2.69 (95% CI 1.82–3.98), very low-quality evidence.
• Adverse events: 2 studies, 379 people; RR 0.91 (95% CI 0.29–2.85), very low-quality evidence. Quality of life and caregiver burden were not measured.

The authors state that the data are imprecise, that the studies carry a high risk of bias, and that a possible benefit might be too small to be clinically meaningful; they write that Cerebrolysin continues to be used and promoted in vascular dementia but that the supporting evidence base is weak. ^[4] In the Austrian product information, Alzheimer-type dementia is also among the indications. ^[1]

Head injury

The prespecified meta-analysis of two phase IIIb/IV RCTs in moderate-to-severe head injury (Glasgow Coma Scale 6–12) covers 185 patients. In the multidimensional primary outcome made up of functional and neuropsychological scales, the Mann-Whitney effect size was 0.60 (95% CI 0.52–0.66) at day 30 and 0.60 (95% CI 0.52–0.68) at day 90; the authors describe this as an effect of “small-to-moderate” size and report similar safety profiles. ^[5] According to its ClinicalTrials.gov record, the sponsor of the first study in the series is the drug’s manufacturer, and the study status appears as “terminated” on grounds of “insufficient patient recruitment.” ^[6] Two studies and 185 patients base the result on a single series of studies whose result has not been independently confirmed.

Side effects and who should not use it

The Austrian product information lists the following points: ^[1]

• Contraindications: Hypersensitivity to the active substance or components, status epilepticus, and severe renal impairment.
• Caution: Caution is needed in allergic predisposition and in epileptic diseases, because seizure frequency may increase.
• Interaction: Additive effects may be seen with antidepressants and MAO inhibitors; blood pressure may rise with high-dose MAO inhibitors.
• Pregnancy and breastfeeding: Not used in pregnancy unless the woman’s clinical condition requires it; during breastfeeding, the decision to stop breastfeeding or treatment is made according to the benefit-risk balance.
• Driving and operating machinery: Because impairment of these abilities cannot be ruled out, it is written that these activities should be avoided.
• Side effects: Very rarely, allergic reactions that can reach a shock-like picture and isolated major seizures; rarely, agitation (aggression, confusion, insomnia) and loss of appetite; with rapid administration, dizziness, a feeling of warmth, and very rarely palpitations or rhythm disturbances.

The increase in non-fatal serious adverse events found by Cochrane in stroke (RR 2.39) comes from a different source than the “very rare” frequency definitions in the product information, namely controlled trials. ^[2] This product information covers only the licensed product; products obtained outside the licensed manufacturing chain fall outside these assurances. For general risks: Peptide side effects.

What do regulators say?

• FDA (US): In FDA orphan drug records, a designation granted on April 5, 2016 for the frontotemporal dementia indication for a “peptide fraction derived from porcine brain protein” appears as “withdrawn or revoked”; the product is not FDA approved for this indication. ^[7] The substance is not named in FDA’s May 14, 2026 list of nominated substances for compounding. ^[8]
• EU: The product holds a national license in Austria; the license holder and product information are published in the Austrian medicines authority’s records. ^[1]
• WADA: The 2026 Prohibited List does not name Cerebrolysin. The S0 class covers only substances not approved by any governmental health authority for human therapeutic use; Cerebrolysin is licensed in Austria. ^{[9] [1]}

For a similar neuropeptide licensed only in some countries:

What is the status of Cerebrolysin in Türkiye?

The legal status of peptides in general: Are peptides legal? The meaning of the “for research purposes” label: What does research peptide mean?

Evidence table: claim, population, and limits

Limits of this guide

This page summarizes published evidence and official documents on Cerebrolysin; it contains no individualized dose, method of administration, cycle length, or product source. In countries where it is licensed, Cerebrolysin is a drug used by physicians, by prescription, in specific neurological diseases. Regulatory status may change; the information on this page is valid as of October 2026.