What the human research shows
Widely used, extensively trialled, and the best-quality summaries of those trials are unconvincing. The stroke evidence is the most important thing on this page: moderate-certainty evidence of no benefit and of more serious adverse events.
Evidence profile0–5
- Metabolic & weight—0.0
- Cardiovascular—0.0
- Muscle & growth—0.0
- Healing & repair—0.0
- Neuro & sleepA0.7
- Immune & inflammation—0.0
- Sexual & hormonal—0.0
- Skin & appearance—0.0
- Ageing & longevity—0.0
| Outcome | Grade | Effect size | Human studies | Where the evidence comes from |
|---|---|---|---|---|
| Survival after acute ischaemic stroke | AEstablished | Not measurable | Cochrane review: 6 RCTs, 1,689 participants | Moderate-certainty evidence of no effect on death. None of the trials reported the outcome that matters most — death or dependence — at all.1 |
| Cognition in vascular dementia | CWeak | Small | Cochrane review: 6 RCTs, 597 participants | A small pooled benefit on cognitive scores, from trials the reviewers rated at high risk of bias and very low quality, with no new trials in a decade. Their own conclusion: if there are benefits, they may be too small to be clinically meaningful.2 |
| Alzheimer's disease | CWeak | Small | Several small RCTs | Small trials report modest short-term improvements on cognitive scales; no large or long trial, no regulatory approval in a major market for this use.3 |
| Traumatic brain injury recovery | CWeak | Small | Small RCTs and cohort studies | A mix of small randomised and observational studies from the countries where it is used; not independently confirmed at scale.3 |
| Serious adverse events (stroke)adverse | AEstablished | Moderate | Cochrane review: 3 RCTs, 1,335 participants | Non-fatal serious adverse events were more than twice as common on Cerebrolysin, and more so at the higher cumulative dose — moderate-certainty evidence.1 |
Literature searched to 10 September 2026. Human studies only; animal and cell work informs the mechanism section and nothing else.
Registered trials
ClinicalTrials.gov lists 37 interventional studies naming Cerebrolysin as an intervention — 16 completed, 3 recruiting, and 3 with results posted to the registry.
A registration is not a result. Anyone can register a study, and many never report — so this list shows what has been attempted, not what has been shown. The graded evidence above is the answer to whether something works.
29 further studies are registered. Participant counts marked * are the sponsor's estimate, not a final enrolment. Source: ClinicalTrials.gov, read directly from the registry and refreshed weekly.
What it is
Cerebrolysin has been made by the same Austrian company since the 1950s: purified pig-brain tissue, enzymatically broken into free amino acids and peptides under 10 kDa. Because it is a mixture, its composition is defined by the process rather than by a formula, and it has no single active ingredient.
It is a registered medicine in Austria and some other countries, and widely used in Russia, China and much of Eastern Europe and Asia, given as 10- to 30-day courses of intravenous infusion. It is not approved by the FDA or MHRA and has no EU-wide authorisation.
How it is thought to work
It is described as neurotrophic — mimicking the effects of nerve growth factors — on the basis of cell and animal work. Which components do what is not established, and whether peptides in the mixture cross the blood-brain barrier is unresolved.
What is still unknown
- Whether any component reaches the brain in an active form.
- Why the largest and best-conducted trials have been the least positive; the reviewers note manufacturer involvement in the main studies.
- Long-term safety of repeated infusion courses.
The molecule and how long it lasts
An undefined mixture of porcine brain peptides — no molecular identity
- Route
- Intravenous or intramuscular as used clinically
- Half-life
- No pharmacokinetic data — an undefined peptide mixture has no single half-life
No pharmacokinetic study in people.
Regulatory status
No central (EU-wide) authorisation. Where authorised, prescription-only and given by infusion.
Not FDA-approved; imported products are unapproved drugs.
No MHRA licence.
Not on the ARTG.
No Drug Identification Number.
Not named on the Prohibited List.
Questions people actually ask
Does Cerebrolysin work for stroke?
Does Cerebrolysin help dementia?
Why is it approved in some countries and not others?
One page per claimed effect
- ADoes Cerebrolysin help with survival after acute ischaemic stroke?Cochrane review: 6 RCTs, 1,689 participants
- CDoes Cerebrolysin help with cognition in vascular dementia?Cochrane review: 6 RCTs, 597 participants
- CDoes Cerebrolysin help with alzheimer's disease?Several small RCTs
- CDoes Cerebrolysin help with traumatic brain injury recovery?Small RCTs and cohort studies
- AHow common is serious adverse events with Cerebrolysin?Cochrane review: 3 RCTs, 1,335 participants
References
- 1Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke.Cochrane Database Syst Rev, 2023;10:CD007026Seven RCTs, 1,773 participants.
- 2Cui S, Chen N, Yang M, et al. Cerebrolysin for vascular dementia.Cochrane Database Syst Rev, 2019;11:CD008900Six RCTs, 597 participants; very low-quality evidence.
- 3Cerebrolysin randomised trials in Alzheimer's disease and traumatic brain injury.PubMed searchSmall trials, largely from countries where the product is established.
Change log
- 2026-09-10Initial publication. Stroke survival graded A (no effect) on moderate-certainty Cochrane evidence; dementia C.