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Cognitive

Cerebrolysin

Also known as Cere · Cerebrolysin concentrate

Approved outside the USAHuman trial evidenceWhat this means

Cerebrolysin is a porcine brain-derived preparation of low-molecular-weight peptides and amino acids given by intravenous infusion or injection. It is authorised in Austria and used in Russia, Eastern Europe, China and other Asian countries for supportive treatment after stroke and head injury and in dementia, but it is not approved by the FDA. Randomized trials and Cochrane reviews report mixed results, including no clear effect on death after acute ischaemic stroke; this entry summarizes them for research reference only.

US status
Approved outside the US
Evidence
Grade A
Half-life
Not measurable directly: the Austrian SmPC states that, as a mixture of short-chain peptides similar or identical to endogenous ones, its pharmacokinetics cannot be measured directly; a neurotrophic effect is detectable in plasma up to 24 hours after a single dose 1
Class
Porcine brain-derived peptide preparation (mixture of low-molecular-weight peptides and amino acids); described as neurotrophic
Studied in: Cognition & neuroprotection · Class: Neuropeptide analogues studied for cognition
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Unbranded reference vial illustrating Cerebrolysin; not an actual product
Research reference, not advice. Amiravo sells nothing; some links are referrals.Read the full notice

Key takeaways

  • Cerebrolysin is a porcine brain-derived peptide and amino-acid mixture authorised in Austria and used widely outside the US; it is not FDA-approved 1,3,9.
  • A 2023 Cochrane review of seven trials (1,773 participants) found moderate-certainty evidence of little to no difference in all-cause death after acute ischaemic stroke 3.
  • The same review found a possible increase in non-fatal serious adverse events with Cerebrolysin (risk ratio 2.39, 95% CI 1.10 to 5.23; moderate certainty) 3.
  • The large CASTA trial (1,070 patients with acute ischaemic stroke) showed no significant difference on its confirmatory endpoint 6.
  • The Austrian label lists status epilepticus and severe renal impairment as contraindications and notes seizure frequency may increase in epileptic disorders 1.

Development stage

Where Cerebrolysin sits between laboratory work and regulatory approval.

  1. Preclinical
  2. Phase 1
  3. Phase 2
  4. Phase 3
  5. Approved (current)

Stage comes from the regulatory record and ClinicalTrials.gov studies naming the compound (for compounds approved nowhere, only completed trials or trials with posted results count) (checked 2026-10-24). A registered trial is not a result.

Mechanism of action

Cerebrolysin is described as a mixture of low-molecular-weight peptides and amino acids derived from porcine brain with potential neuroprotective properties 3, and as a preparation said to have neurotrophic and neuroprotective activity 4.

Pharmacology

The Austrian SmPC states that direct pharmacokinetic measurement is not possible because the product is a mixture of short-chain peptides similar or identical to endogenous ones; parameters were inferred from pharmacodynamic data, and preclinical data indirectly suggest that components cross the blood-brain barrier 1.

What is not established

Because the active components are not individually defined, the specific molecular mechanism has not been established in the sources reviewed.

Research overview

Human research

In acute ischaemic stroke, a 2023 Cochrane review (seven trials, 1,773 participants) found little to no difference in all-cause death and in total serious adverse events, with a possible increase in non-fatal serious adverse events 3. The CARS rehabilitation trial reported better upper-extremity motor scores at day 90 with Cerebrolysin than placebo 5, whereas CASTA showed neutral results on its confirmatory endpoint 6. In vascular dementia, a Cochrane review of six trials (597 participants) found improvements in cognition and global function based on very low-quality evidence 4. Trials in Alzheimer's disease and traumatic brain injury have also been reported 7,8.

Animal research

The CASTA report states that Cerebrolysin showed neuroprotective and neurotrophic properties in various preclinical ischaemia models 6; specific animal studies were not reviewed for this entry.

In-vitro research

Not reviewed for this entry; the SmPC states that preclinical data indirectly suggest components cross the blood-brain barrier 1.

Key studies

  1. Ziganshina et al., Cochrane Database Syst Rev (acute ischaemic stroke) (2023)
    Systematic review and meta-analysis of seven RCTs, 1,773 participants (including one trial of the related agent Cortexin)
    Model: Humans (adults with acute ischaemic stroke)

    All-cause death RR 0.96 (95% CI 0.65 to 1.41; moderate certainty); total serious adverse events RR 1.16; non-fatal serious adverse events RR 2.39 (95% CI 1.10 to 5.23); the authors concluded that Cerebrolysin probably does not reduce all-cause death 3.

  2. Heiss et al., Stroke (CASTA) (2012)
    Randomized, double-blind, placebo-controlled, 1,070 patients, 90-day follow-up (NCT00868283)
    Model: Humans (patients with acute ischaemic hemispheric stroke in Asia)

    The confirmatory endpoint showed no significant difference between groups; a post hoc analysis suggested a trend favouring Cerebrolysin in patients with NIHSS above 12 6.

  3. Muresanu et al., Stroke (CARS) (2016)
    Randomized, double-blind, placebo-controlled, multicenter, exploratory; outcome at day 90 (EudraCT 2007-000870-21)
    Model: Humans (patients after ischaemic stroke in early rehabilitation)

    Action Research Arm Test at day 90 favoured Cerebrolysin (Mann-Whitney estimator 0.71); premature discontinuation was 3.8%; the authors called for confirmation in a larger trial 5.

  4. Cui et al., Cochrane Database Syst Rev (vascular dementia) (2019)
    Systematic review of six RCTs, 597 participants
    Model: Humans (people with mild to moderate vascular dementia)

    Cognition SMD 0.36 and global function response RR 2.69 favoured Cerebrolysin, both very low-quality evidence; no difference in adverse effects; the authors described the evidence base as weak 4.

  5. Alvarez et al., Eur J Neurol (Alzheimer's disease) (2006)
    Randomized, double-blind, placebo-controlled, three dose levels, 24 weeks, 279 patients
    Model: Humans (patients with mild to moderate Alzheimer's disease)

    At week 24, ADAS-cog improved significantly only at the lowest dose level, and global function (CIBIC+) at all three; the proportion with adverse events was similar across groups 7.

  6. Poon et al., Neurol Sci (CAPTAIN I) (2020)
    Randomized, double-blind, placebo-controlled phase IIIb/IV, 46 patients
    Model: Humans (patients with moderate-to-severe traumatic brain injury)

    The primary multivariate endpoint narrowly missed significance in the intention-to-treat population but was significant per protocol; safety aspects were comparable to placebo 8.

Dosing as stated on non-US labeling

What investigators administered in the cited studies, recorded as a fact about those studies. Not a protocol and not a recommendation.

Full dosing reference, study durations and vial arithmetic →
  • Austrian SmPC (Zulassungsnummer 1-21380, March 2021) posology: daily doses of 10 to 30 mL for 4 weeks in dementia; 20 to 50 mL for 10 to 21 days in ischaemic stroke; 30 to 50 mL for 10 to 21 days in haemorrhagic stroke; 20 to 50 mL for 7 to 30 days in craniocerebral trauma; given intramuscularly (up to 5 mL), intravenously (up to 10 mL) or, from 10 mL, by slow infusion after dilution; one treatment cycle is 4 weeks with 5 administrations per week, and in dementia cycles may be repeated after 2 months 1. Not recommended under 18 years 1.
  • In CASTA (NCT00868283), patients with acute ischaemic stroke were randomized within 12 hours of onset to Cerebrolysin 30 mL daily or saline placebo by intravenous infusion for 10 days, in addition to aspirin 100 mg daily, with 90-day follow-up 6.
  • In CARS, patients received Cerebrolysin 30 mL/day or saline placebo once daily for 21 days, starting 24 to 72 hours after stroke onset, alongside a standardized 21-day rehabilitation programme 5.
  • In the Alzheimer's disease trial, 279 patients received intravenous infusions of Cerebrolysin 10, 30 or 60 mL or placebo 5 days per week for 4 weeks, then two infusions per week for 8 weeks, with assessment to week 24 7.
  • In CAPTAIN I, patients with traumatic brain injury received 50 mL of Cerebrolysin or saline daily for 10 days, followed by two further treatment cycles of 10 mL daily for 10 days, added to standard care 8.

Cerebrolysin draw calculator

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Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

  • Non-fatal serious adverse events
    RR 2.39 (95% CI 1.10 to 5.23) vs placebo; RR 2.87 in the subgroup with 10-day courses
    Acute ischaemic stroke, 3 trials, 1,335 participants (Cochrane) 3 · Serious; moderate-certainty evidence
  • Any adverse event
    RR 1.03 (95% CI 0.92 to 1.14) vs placebo
    Acute ischaemic stroke, 4 trials, 1,607 participants (Cochrane) 3 · Low-certainty evidence
  • Allergic or hypersensitivity reactions (skin and local vascular reactions, fever, dyspnoea, chills, shock-like states)
    Very rare (label category)
    Austrian SmPC 1 · Can be serious
  • Isolated grand mal seizures
    Very rare (label category)
    Austrian SmPC 1 · Serious
  • Palpitations or arrhythmia with rapid administration
    Very rare (label category)
    Austrian SmPC 1 · Not graded
  • Agitation, insomnia or confusion; dizziness, warmth, sweating or itching with rapid administration; loss of appetite
    Rare (label category)
    Austrian SmPC 1 · Not graded

Emerging safety signals

  • The 2023 Cochrane review reported moderate-certainty evidence of a potential increase in non-fatal serious adverse events with Cerebrolysin in acute ischaemic stroke, more prominent with 10-day courses (meta-analysis evidence) 3. 3 (2023)
  • The Austrian SmPC advises caution in allergic diathesis and epileptic disorders because seizure frequency may increase, and lists status epilepticus and severe renal impairment as contraindications (national label evidence) 1. 1 (2021)
  • Cochrane reviewers noted that the manufacturer supported three multicentre stroke trials and that risk of bias was unclear or high in several domains (systematic review evidence) 3. 3 (2023)

What is not known: Cerebrolysin is a mixture whose individual active components are not defined, so molecular identity, pharmacokinetics and mechanism cannot be specified 1. Cochrane reviewers found no trial reporting death or dependence, quality of life or return to work after acute stroke, and judged several domains at unclear or high risk of bias 3. For vascular dementia, any effect may be too small to be clinically meaningful 4. Use in people under 18 is not recommended in the Austrian label because of insufficient data 1.

Clinicians and researchers on video

YouTube videos about Cerebrolysin from clinicians and researchers. Their views, in their own words; not reviewed or endorsed by Amiravo. Compare what they say with the evidence above.

  • Cerebrolysin Explained: Can It Really Support Brain Repair?
    Dr. Hany Demian · 597 views · 2026

These creators are not affiliated with Amiravo and do not endorse Amiravo or any product linked on this site. Nothing here is medical advice. Video views counted on YouTube as of Oct 24, 2026.

Regulatory status

Status
Authorised in Austria (Zulassungsnummer 1-21380, EVER Neuro Pharma GmbH) as a prescription-only parenteral solution for supportive treatment of cerebrovascular disorders, including Alzheimer-type senile dementia, vascular dementia, post-stroke deficits and craniocerebral trauma, in adults and patients over 65 1. A 2023 Cochrane review states that it is widely used for acute ischaemic stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries 3. Not approved by the FDA; an openFDA query returned no application record 9.
United States (FDA)
Not approved; an openFDA Drugs@FDA query for cerebrolysin returned no application record 9. Cerebrolysin does not appear in any category of FDA's May 14, 2026 list of bulk drug substances nominated for compounding under section 503A 10.
Sport (WADA)
Cerebrolysin is not named on the WADA 2026 Prohibited List 11. Class S0 applies to substances with no current approval by any governmental regulatory health authority for human therapeutic use 11; Cerebrolysin holds a national authorisation in Austria 1.

Status varies by country and changes over time. How we describe regulatory status.

Quality and testing notes

Because Cerebrolysin is a biological mixture, a certificate of analysis cannot rely on a single intact mass. Relevant characterisation includes source and species declaration (porcine brain), the stated concentrate content per mL (215.2 mg/mL in the Austrian product), peptide and free amino-acid profiles, sterility, endotoxin and viral or prion-safety documentation consistent with an animal-derived product, and batch-to-batch fingerprinting [1]. Material sold as 'Cerebrolysin' outside the authorised supply chain cannot be assumed to match the licensed product.

How purity testing works · Reading a certificate of analysis

Check a Cerebrolysin certificate of analysis

Storage and handling

The Austrian SmPC states: store below 25 degrees C, do not refrigerate or freeze, and keep in the original packaging to protect from light [1].

Frequently asked questions

Is Cerebrolysin FDA-approved?
No. An openFDA query returned no application record 9. It is authorised in Austria and used in many other countries 1,3.
What is Cerebrolysin made of?
A mixture of low-molecular-weight peptides and amino acids derived from porcine brain 3.
Does Cerebrolysin reduce death after stroke?
A 2023 Cochrane review found moderate-certainty evidence that it probably makes little to no difference to all-cause death in acute ischaemic stroke 3.
What did the CARS trial report?
Better upper-extremity motor scores at day 90 with Cerebrolysin than placebo in an exploratory rehabilitation trial 5.
What are the label contraindications?
Hypersensitivity to the active substance or excipients, status epilepticus and severe renal impairment, per the Austrian SmPC 1.
How is it given?
By intramuscular injection, intravenous injection or intravenous infusion, per the Austrian SmPC 1.
Does it have a half-life?
The SmPC states its pharmacokinetics cannot be measured directly because it is a peptide mixture 1.

Latest indexed research

Search all studies on Cerebrolysin (PubMed, Europe PMC, ClinicalTrials.gov)

Listed by publication type from the index record. Inclusion is not an endorsement; open the source to read the findings.

Revision history

Meaningful changes to this entry, with dates and sources. Last reviewed Oct 23, 2026. Typo and layout fixes are not listed.

No recorded changes since the change log began on Oct 23, 2026.

References

  1. Cerebrolysin parenterale Loesung, Fachinformation (summary of product characteristics), Zulassungsnummer 1-21380, EVER Neuro Pharma GmbH, Stand Maerz 2021 BASG (Austrian Federal Office for Safety in Health Care). 2021
  2. Cerebrolysin parenterale Loesung, Gebrauchsinformation (patient leaflet), EVER Neuro Pharma GmbH, Stand Maerz 2021 BASG (Austrian Federal Office for Safety in Health Care). 2021
  3. Cerebrolysin for acute ischaemic stroke Cochrane Database Syst Rev. 2023
  4. Cerebrolysin for vascular dementia Cochrane Database Syst Rev. 2019
  5. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial Stroke. 2016
  6. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial Stroke. 2012
  7. A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease Eur J Neurol. 2006
  8. 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
  9. Drugs@FDA application data queried through openFDA for cerebrolysin (no matching application record returned on 23 October 2026) openFDA / Drugs@FDA. 2026
  10. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (categories 1, 2 and 3; updated May 14, 2026) FDA. 2026
  11. International Standard: Prohibited List 2026 World Anti-Doping Agency. 2026

Last reviewed October 23, 2026 by the Amiravo editorial team.

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For research use only. Not for human or veterinary use. Not a drug, food, or dietary supplement. This page is educational and is not medical advice.

Unbranded reference vial illustrating Cerebrolysin; not an actual product

Unbranded reference image. Amiravo does not produce, supply or sell this compound.

Specifications

Format
Lyophilized vial
Vial sizes seen
60 mg
Other forms seen
Liquid ampoules/vials 215.2 mg/mL (clinical product)
Type
Single compound

Chemical identifiers are shown only when verified against PubChem.

Research stats

How much has been published, not how good it is.

PubMed records
639
Indexed as human research
328
Animal-only research
203
Randomized controlled trials
61
Registered trials
43
Trials with posted results
3
FDA adverse-event reports (FAERS)
80
NIH-funded projects naming it
3
2006: 142007: 112008: 122009: 112010: 182011: 192012: 162013: 222014: 232015: 242016: 302017: 312018: 242019: 362020: 302021: 322022: 222023: 432024: 352025: 472026: 2920062026
PubMed records per year (current year is partial).

Counts from title/abstract searches of PubMed, ClinicalTrials.gov, openFDA and NIH RePORTER, checked 2026-10-24. Names shared with other substances can inflate counts. FAERS reports are spontaneous and do not establish cause. Funding shows interest, not evidence. Method

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