Cerebrolysin

FPF-1070, Cerebrolysin® (EVER Pharma), porcine brain peptide preparation

Cognitive & neuro

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Note on this profile. Cerebrolysin is an approved prescription medicine in a number of countries (including Austria, Russia, China, South Korea and several in Eastern Europe, Asia and Latin America) for stroke, dementia and traumatic brain injury. It is not approved in the US, UK or by the EMA for EU-wide use, and its evidence base is contested. It is a biological product made from animal tissue, not a defined synthetic peptide.

Summary

Class: Standardised mixture of low-molecular-weight peptides (under 10 kDa) and free amino acids produced by enzymatic breakdown of purified pig brain proteins; roughly 85% amino acids and 15% peptides by mass
Mechanism: Claimed to mimic the actions of neurotrophic factors (nerve growth factor, BDNF, CNTF) — supporting neuron survival, reducing inflammation and excitotoxic damage after injury — though no single active component has been identified
Routes studied: Intravenous infusion and intramuscular injection (human trials); intraperitoneal (rodent); intramuscular and subcutaneous (community)
Dose range reported: Approved labels: 10–50 ml/day IV over 10–21 days in acute stroke and TBI (30 ml/day most common in trials); 5–30 ml/day IM or IV in dementia, typically 5 days a week for 4 weeks. Community: 5–10 ml/day IM for 10–20 days, repeated in courses. Label and community figures, not recommendations
Half-life: Not meaningfully measurable for a mixture; individual peptides are cleared within hours. Effects are attributed to trophic signalling rather than sustained blood levels
Storage: Ampoules: room temperature (below 25 °C), protect from light, do not freeze; use immediately after opening. Not a lyophilised product
Regulatory status: Approved in ~45 countries; not approved in US, UK, EU-wide (some individual EU member states have national approvals)

Doses are as reported in studies or by the community — never recommendations.

1What it is

Cerebrolysin is made by taking purified proteins from pig brain and digesting them with enzymes into a soup of small peptides and amino acids. It has been manufactured in Austria since the 1950s, originally by EBEWE and now by EVER Pharma. It is given by injection or infusion in courses, usually in hospital or clinic settings. Because it is a mixture, the exact composition is defined by the manufacturing process rather than by a chemical formula, and the manufacturer has not published a full inventory of its peptide components. It is one of the few compounds on this site that is a licensed biological medicine with a long clinical history, and also one where large trials have produced genuinely conflicting results.

2How it's thought to work

Neurotrophic mimicry. the mixture is reported to contain fragments that act like nerve growth factor, BDNF, ciliary neurotrophic factor and others, supporting neuronal survival and sprouting in culture.

Anti-excitotoxic and anti-apoptotic. reduces glutamate-driven calcium overload, free-radical damage and programmed cell death in neuron culture and animal stroke models.

Reduced amyloid and tau pathology in mouse Alzheimer's models.

Promotes neurogenesis and oligodendrocyte survival. in rodent models.

Honest caveat. which components do what is unknown. A mixture that is 85% amino acids will produce some metabolic effects that have nothing to do with neurotrophins.

A mixture of small peptides and amino acids from pig brain, not a single molecule. Proposed to act like the body's own nerve growth factors, supporting neuron survival and sprouting.Schematic — not to scale

3What the research shows

Graded A (mixed)

Acute ischaemic stroke

The CASTA trial (n=1,070, 30 ml/day IV for 10 days) found no significant difference from placebo on the primary global outcome at 90 days, with a post-hoc signal in more severe strokes (Heiss 2012, Stroke). CARS-1 (n=208) reported better upper-limb motor recovery with Cerebrolysin plus rehabilitation (Muresanu 2016, Stroke); CARS-2 did not replicate this. A 2020 Cochrane review (seven trials, n=1,773) concluded there was moderate-quality evidence of no benefit on death or dependence, and a possible increase in serious adverse events (Ziganshina 2020, Cochrane Database Syst Rev). Meta-analyses funded or co-authored by the manufacturer have reached more favourable conclusions. This is the most contested area. [1][2][3]

Graded A (modest, older trials)

Alzheimer's disease and vascular dementia

Several double-blind placebo-controlled trials in the 1990s–2000s reported improvements in cognition and global function with 30 ml IV, five days a week for four weeks (Ruether 2001; Alvarez 2006, Eur J Neurol). A Cochrane review of vascular dementia (Chen 2013) found some evidence of benefit on cognitive and global outcomes but rated the evidence as low quality; a 2019 update found no significant benefit at longer follow-up. No large modern trial exists. [4][5]

Graded A/B

Traumatic brain injury

The CAPTAIN trials (Phase 3-style, moderate size) reported benefit on a composite of neurological outcomes at 90 days (Poon 2020, Neurol Sci); methodology and multiplicity of endpoints have been criticised. Earlier observational data were supportive. [6]

Neurotrophic and neuroprotective effects in animals

Consistent reductions in infarct size, improved functional recovery, reduced amyloid pathology and increased neurogenesis across rodent models (Hartbauer 2001; Rockenstein 2006, J Neural Transm; Zhang 2010). [7]

Graded B/—

Children with cerebral palsy or developmental delay, autism, "brain optimisation"

Small Eastern European studies and community use; design quality is poor to absent.

4Reported side effects and interactions

Literature-reported

Generally well tolerated in trials. Reported: injection-site reactions, dizziness, headache, agitation or insomnia (particularly with fast infusion), nausea, sweating, flushing, mild fever, rare allergic reactions. The 2020 Cochrane stroke review reported a higher rate of non-fatal serious adverse events in treated patients (relative risk around 2.1), which the manufacturer disputes †.

Community-reported

injection-site pain and bruising with IM use (volumes of 5–10 ml per injection are large), restlessness, vivid dreams, headache, fatigue after courses, occasional mood changes.

Theoretical. as an animal-derived biological, prion and viral transmission has been raised; the manufacturer uses prion-free certified herds and a manufacturing process reported to inactivate prions, and no case has been documented. Allergic sensitisation with repeated courses. Effects of chronic neurotrophin-mimicking exposure are unknown.

Interactions. the label advises against mixing in the same infusion with balanced amino-acid solutions, and notes additive effects with antidepressants (particularly MAO inhibitors) — dose reduction of the antidepressant has been suggested. Not for use in epilepsy with active seizures or severe kidney impairment per label.

Markers researchers commonly monitor

Marker	Why it's watched
Standardised neurological and cognitive scales (NIHSS, mRS, ADAS-cog, MMSE)	the only efficacy readouts used in trials; no blood marker of effect exists.
Kidney function (creatinine, eGFR)	label contraindication in severe renal impairment, and the amino-acid load is a nitrogen burden.
Liver enzymes	reasonable with any repeated biological infusion; no specific signal reported.
Blood pressure and heart rate during infusion	flushing and agitation with rapid administration.
Temperature and signs of hypersensitivity after each course	allergic reactions are rare but documented.
Seizure history	the label cautions in epilepsy.

Free for everyone. Safety information is never behind a paywall.

5Reconstitution and handling

Cerebrolysin is a ready-to-use solution in 1, 2, 5, 10, 30 and 50 ml ampoules and needs no . Label guidance: IM injections up to 5 ml; IV injections up to 10 ml slowly; larger volumes by slow infusion diluted in saline or glucose over 15–60 minutes. Fast infusion is associated with agitation and flushing. The reconstitution calculator does not apply.

Open in calculator, pre-loaded →

6Commonly studied alongside

Rehabilitation therapy (CARS trials), thrombolysis (alteplase; combined safely in trials), cholinesterase inhibitors (donepezil — small combination trial, Alvarez 2011). Community: Semax, Selank, noopept, Dihexa.

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	Not FDA-approved. No IND-stage programme currently active as far as this review could establish. Importation for personal use is unlawful †
European Union	No EMA centralised authorisation. National marketing authorisations exist in Austria (country of manufacture) and some Eastern European member states †; Germany withdrew or let lapse its authorisation †
United Kingdom	Not licensed
Australia	Not approved
South Africa	Not registered †
Russia / China / South Korea / others	Approved and widely used in stroke, dementia and TBI
Sport	Not specifically named by WADA; S0 (non-approved) would apply only in jurisdictions where it is not approved — an unusual edge case †

8Open questions

Is there any clinically meaningful benefit in acute stroke, or does the balance of large trials point to none?
Which components, if any, are responsible for the neurotrophic effects seen in animals?
Does the serious-adverse-event signal in the Cochrane stroke review reflect a real risk?
Would an independent, adequately powered dementia trial with modern endpoints show benefit?

9References

1Heiss WD et al. (2012). Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial (CASTA). Stroke. PubMed · DOI
2Muresanu DF et al. (2016). Cerebrolysin and recovery after stroke (CARS): a randomized, placebo-controlled, double-blind, multicenter trial. Stroke. PubMed · DOI
3Ziganshina LE et al. (2020). Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. PubMed · DOI
4Chen N et al. (2013). Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. PubMed · DOI
5Alvarez XA et al. (2006). 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. PubMed · DOI
6Poon W et al. (2020). Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I — a randomized, placebo-controlled, double-blind, Asian-Pacific trial. Neurol Sci. PubMed · DOI
7Rockenstein E et al. (2006). Effects of Cerebrolysin on neurogenesis in an APP transgenic model of Alzheimer's disease. Acta Neuropathol. PubMed · DOI
8Masliah E, Díez-Tejedor E (2012). The pharmacology of neurotrophic treatment with Cerebrolysin: brain protection and repair to counteract pathologies of acute and chronic neurological disorders. Drugs Today. PubMed · DOI

† Being confirmed by our reviewers against current sources.

10Community

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Self-reported side effects Phase 2

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11Page history

25 Oct 2026Profile published — awaiting medical review

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