Cerebrolysin
Mixture of low molecular weight peptides and free amino acids derived from porcine brain
Status
Approved elsewhere
Marketed and widely used for stroke and dementia in Russia, eastern Europe, China and other Asian and post-Soviet countries, but never approved by the FDA or the EMA; the exact registration authority and date differ by country and could not be verified from primary sources for this entry.
Evidence
Moderate
The human evidence base is unusually large for this kind of product, with seven randomised trials pooled in a Cochrane review, and it shows no benefit on death or function after stroke plus a probable increase in non-fatal serious adverse events.
A mixture of short peptides and amino acids made from pig brain tissue, given by infusion for stroke and dementia in parts of Europe and Asia. Randomised trials have not shown a clinical benefit.
Structure
No single sequence to draw
Cerebrolysin is not a single peptide. It is a manufactured mixture of low molecular weight peptides and free amino acids obtained by enzymatic breakdown of purified porcine brain protein, so no sequence can be given and batch composition cannot be verified by sequencing.
What it is used for
- Acute ischaemic stroke, as a marketed product in Russia, eastern Europe and parts of Asia (approved)
- Vascular dementia (studied)
- Traumatic brain injury and post-stroke cognitive impairment (studied)
- Alzheimer disease and general nootropic use (claimed, unproven)
How it works
The preparation is described by its makers as neurotrophic, meaning the peptide fragments are supposed to act like the growth factors that keep neurons alive and support repair after injury. Because the product is a mixture rather than a defined molecule, no single receptor or pathway can be assigned to it, and the neurotrophic account rests largely on laboratory models rather than on measured drug exposure in the human brain.
How strong the evidence is
Moderate
The 2023 Cochrane review of acute ischaemic stroke pooled seven randomised trials with 1,773 participants, including one trial of the related agent Cortexin. Cerebrolysin probably makes little or no difference to all-cause death (risk ratio 0.96, 95% confidence interval 0.65 to 1.41, moderate certainty), while the number of people with non-fatal serious adverse events probably increases (risk ratio 2.39, 95% confidence interval 1.10 to 5.23). None of the trials reported death or dependence at the end of follow-up. A separate Cochrane review in vascular dementia found possible cognitive effects but did not recommend routine use, citing study limitations.
Risks and side effects
- Cochrane found a probable increase in non-fatal serious adverse events, most pronounced with the higher cumulative dosing schedule studied
- No demonstrated benefit on survival or on functional recovery after stroke, so it can displace treatments that do work
- Three of the pooled multicentre trials were supported by the manufacturer, and risk of bias was unclear or high in most studies
- The product is an undefined biological mixture from animal brain tissue, so identity and batch-to-batch consistency cannot be checked by sequence
- Never reviewed by the FDA or the EMA, so no independent assessment of manufacturing quality or safety exists in those regions
Regulatory status
Status by country
| Jurisdiction | Status | Source |
|---|---|---|
| USUnited States | No authorised medicine | Source 5 |
| EUEuropean Union | Authorised in some member states | Source 6 |
| UKUnited Kingdom | No authorised medicine | Source 7 |
| AUAustralia | No authorised medicine | Source 8 |
| CACanada | No authorised medicine | Source 9 |
Sources
- 01Cerebrolysin for acute ischaemic stroke (Cochrane Database of Systematic Reviews, CD007026.pub7)(opens the source in a new tab)
- 02Cerebrolysin for vascular dementia (Cochrane Database of Systematic Reviews, CD008900)(opens the source in a new tab)
- 03Cerebrolysin for acute ischaemic stroke (previous version, CD007026.pub6)(opens the source in a new tab)
- 04Cerebrolysin for acute ischaemic stroke: plain language summary(opens the source in a new tab)
- 05Warning Letter: Tailor Made Compounding LLC (MARCS-CMS 594743), April 1, 2020(opens the source in a new tab)
- 06Cerebrolysin, parenterale Lösung: Zusammenfassung der Merkmale des Arzneimittels (Z.Nr. 1-21380)(opens the source in a new tab)
- 07MHRA Products: active substances beginning with C(opens the source in a new tab)
- 08Australian Register of Therapeutic Goods (ARTG)(opens the source in a new tab)
- 09Drug Product Database online query(opens the source in a new tab)
Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.