Cerebrolysin is an injectable mixture of small peptides and amino acids made from pig brain tissue. Cochrane reviewers describe it as widely used for stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries,[3] and in Russia it is also prescribed for dementia and brain injury.[1] Large trials and Cochrane reviews have produced mixed results, and it is not FDA-approved.[2][3]

What is Cerebrolysin?

Cerebrolysin’s Russian registration is held by EVER Neuro Pharma of Austria, and the label lists manufacturing sites in Russia and Germany. The label describes it as a peptide complex from pig brain, 215.2 mg per mL, supplied in ampoules of 1 to 20 mL.[1] It is said to have neurotrophic and neuroprotective activity, meaning it is thought to support nerve cell survival and repair,[9] but these properties come mainly from preclinical models.[5]

The Russian label lists these uses in adults:[1]

  • Alzheimer’s disease and other causes of cognitive impairment, including dementia
  • Chronic poor blood flow to the brain
  • Ischemic stroke
  • Traumatic brain injury
  • Depression that has not responded to antidepressants (with other drugs)

It is also approved there for children with developmental delay or attention and hyperactivity problems.[1]

Cerebrolysin for stroke: what the research shows

Acute stroke trials

  • CASTA (2012): 1,070 patients in Asia received 30 mL a day or saline for 10 days, starting within 12 hours of stroke. There was no significant difference on the main outcome. In a post hoc subgroup analysis of patients with more severe strokes (NIHSS above 12), 90-day death rates were 10.5% with Cerebrolysin and 20.2% with placebo. Because this subgroup was not prespecified, the authors described it only as a favorable trend that should be confirmed in a new trial.[5]
  • Cochrane review (2023): the review included 7 randomized trials with 1,773 people. Pooling 6 trials (1,689 people), Cerebrolysin or a similar cattle-brain product (Cortexin) probably made little or no difference to deaths (risk ratio 0.96). It probably did not change the overall number of people with serious adverse events, but non-fatal serious adverse events were more common (risk ratio 2.39). The increase was larger with 30 mL a day for 10 days (risk ratio 2.87).[3] The 2020 edition reached similar conclusions (deaths risk ratio 0.90; non-fatal serious adverse events risk ratio 2.15).[4]

The Cochrane authors also noted that the manufacturer supported three of the multicenter trials and that most trials had unclear or high risk of bias in some areas.[3]

Stroke rehabilitation

  • CARS (2016): patients received 30 mL a day or placebo for 21 days, starting 24 to 72 hours after stroke, alongside a standard rehab program. Arm function at day 90 was clearly better with Cerebrolysin. The authors called the study exploratory and relatively small, and three of them worked for the manufacturer, EVER Neuro Pharma.[6]
  • CARS 1 and 2 combined: in 442 patients, Cerebrolysin improved arm function and early stroke scores. About 7 people needed treatment for one extra person to have a meaningful early improvement.[7] Several authors reported research grants, advisory roles or employment with the manufacturer.[7]
  • European guideline (2021): a guideline from the European Academy of Neurology and the European Federation of Neurorehabilitation Societies recommended Cerebrolysin (30 mL a day IV for at least 10 days) for clinical use in early neurorehabilitation after acute ischemic stroke.[8] Three of its authors were also authors of the CARS trial.[6][8]

Cerebrolysin for dementia and Alzheimer’s disease

  • Vascular dementia (Cochrane, 2019): 6 trials with 597 people suggested better thinking and overall function, but the evidence was very low quality. The reviewers said any benefit may be too small to matter clinically and the evidence base is weak.[9]
  • Alzheimer’s disease: a meta-analysis of 6 placebo-controlled trials of 30 mL a day found better thinking scores at 4 weeks (not significant at 6 months) and better overall clinical ratings at 4 weeks and 6 months.[10]
  • Versus donepezil: in 197 people with mild to moderate Alzheimer’s, Cerebrolysin, donepezil and the combination had similar thinking scores at 28 weeks; overall ratings favored Cerebrolysin and the combination.[11]

Cerebrolysin for traumatic brain injury (CAPTAIN)

  • CAPTAIN I: in 46 patients with moderate to severe brain injury, the main combined outcome just missed statistical significance.[12]
  • CAPTAIN II: in 142 patients, a set of 13 outcome scales showed a small-to-medium benefit at day 90.[13]
  • Combined analysis: across 185 patients, the benefit was small to medium at days 30 and 90, with side effects similar to placebo.[14]

Russian research

Russia is one of Cerebrolysin’s largest markets, and much research is published in Russian:

  • A small double-blind trial in 36 patients found smaller brain lesions on MRI at day 3 with Cerebrolysin, and a trend toward faster recovery.[15]
  • A 277-patient multicenter study, compared with standard care alone, reported faster improvement on stroke scales.[16]
  • CEREHETIS, an open-label trial in 341 patients given clot-busting alteplase, found fewer symptomatic brain bleeds with Cerebrolysin, but no difference in disability at day 90.[17]
  • In an open 3-year study of 100 older adults with mild cognitive impairment, yearly courses were linked to slower decline and fewer cases of dementia.[18]

Not all Russian reviewers are positive. A 2013 Russian-language review found only one trial that met its quality criteria and called the evidence insufficient.[19]

Cerebrolysin dosage

Cerebrolysin is dosed in milliliters of solution. The Russian label gives these daily doses, usually as courses of 10 to 20 days that may be repeated:[1]

Use (Russian label)Daily dose
Alzheimer’s disease10 to 30 mL
Cognitive impairment, including dementia5 to 30 mL
Ischemic stroke, acute phase10 to 50 mL
Stroke recovery5 to 30 mL
Traumatic brain injury5 to 50 mL
Children0.1 to 0.2 mL per kg

Up to 5 mL can be injected into a muscle and up to 10 mL into a vein. Doses of 10 to 50 mL must be diluted and infused slowly over 15 to 60 minutes.[1] The major trials used 30 to 50 mL a day intravenously.[5][6][13]

Cerebrolysin side effects

  • Label: rare dizziness, feeling hot, sweating and itching (mostly with fast injection), loss of appetite, agitation, aggression, confusion and insomnia. Very rare allergic reactions, fast heartbeat, digestive upset and isolated seizures.[1]
  • Contraindications: allergy to the product, severe kidney failure and status epilepticus. It should be used with caution in epilepsy because seizures may become more frequent.[1]
  • Interactions: it may add to the effects of antidepressants, and high doses with MAO inhibitors may raise blood pressure.[1]
  • Trials: a manufacturer-linked safety review found adverse events at similar rates to placebo, most often vertigo, agitation and feeling hot.[20] Independent Cochrane reviewers found more non-fatal serious adverse events in acute stroke trials.[3]

Cerebrolysin vs Semax

CerebrolysinSemax
What it isMixture of peptides from pig brain[1]One synthetic 7-amino-acid peptide
How it’s givenInjection or IV infusion[1]Nasal drops
Russian usesDementia, stroke, brain injury[1]Stroke, cognitive problems
Large placebo-controlled trialsYes, with mixed results[3][5]No

For other peptides studied for memory and focus, see our cognitive peptides overview.

  • Not FDA-approved. The manufacturer states that Cerebrolysin is not registered with FDA and is not approved for sale or distribution in the United States.[2]
  • Abroad: it is a prescription medicine in Russia, where EVER Neuro Pharma holds the registration.[1]

This is general information, not legal advice.

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