Cerebrolysin
Neuropeptide preparation (porcine brain)
Also Cerebrolysine, FPF 1070, FPF-1070, Porcine brain peptides
- Evidence
- BSome human evidence
- FDA status
- Not approvedas of 2026-10-26
- Route
- Intravenous
- Studies cited
- 9 human3 animal or cell
It is an injection promoted for stroke recovery, memory and brain injury. Trials point both ways, and the biggest review found no fewer deaths and more serious side effects.
Sold for
Cerebrolysin is promoted in nootropic and longevity circles as a brain-repair injection that speeds stroke recovery, sharpens cognition and treats dementia.
Studies say
Randomized trials exist, which earns a B, but the largest independent synthesis found no effect on death or dependence after stroke and a rise in serious adverse events, while smaller manufacturer-backed trials found small functional gains.
Why grade B. For the stroke-recovery use there are randomized placebo-controlled trials, but they point in different directions. A Cochrane review pooled six RCTs with 1,501 participants and found no reduction in deaths and more non-fatal serious adverse events; the CARS trial (208 patients) and the two CAPTAIN trials in brain injury (185 patients pooled) reported modest functional benefits. Several trials were manufacturer-supported and had high risk of bias, so the grade stops at B. 362
FDA. Cerebrolysin is not approved by the FDA for any use. It is a licensed medicine in more than 50 other countries, mainly in Eastern Europe, Russia and Asia, for stroke, dementia and brain injury. 13
Written from 9 cited sources. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Recovery after stroke or brain injury, and memory
- Can a US doctor prescribe it?
- No. It is not approved in the US; it is licensed in over 50 other countries.
- Properly tested in people?
- Partly: some human trials, with gaps. Trials are small and many were paid for by the maker.
Evidence checklist
- Randomised controlled trial Cochrane review of 6 RCTs; CARS, CAPTAIN trialsyes
- Human study over 100 people Cochrane pooled 1,501 participantsyes
- More than one research group Many trials manufacturer-supported, high bias riskno
- Clinical outcomes, not surrogate markers Death and dependence after stroke assessedyes
- Human safety data beyond case reports Pooled data: 2.5x more serious non-fatal eventsyes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Cerebrolysin is a mixture of low-molecular-weight peptides and free amino acids extracted from pig brain tissue. It is made by one company, EVER Neuro Pharma of Austria, and given by injection or infusion in courses lasting days to weeks. 31
Because it is a biological extract and not a single defined molecule, the exact active components are not characterized, which is one reason regulators in the United States and Western Europe have not approved it. It is not a peptide you can buy as a defined research chemical in the way BPC-157 or TB-500 are sold; products labelled Cerebrolysin online are imported pharmaceutical vials. 3
How it works
The proposed mechanism is that the peptide fraction mimics neurotrophic factors, the proteins that keep neurons alive and encourage them to form new connections. Laboratory studies describe anti-apoptotic effects (reducing programmed cell death), protection against excitotoxicity (damage from excess glutamate signalling) and support of nerve-cell sprouting. These are cell and animal findings, and a 2021 review notes that the clinical results they predict have been inconsistent. 7891
What human research shows
The 2017 Cochrane review of Cerebrolysin for acute ischaemic stroke identified six randomized trials with 1,501 participants. Deaths were 46 of 714 on Cerebrolysin against 47 of 703 on placebo, no difference. Non-fatal serious adverse events were more common with Cerebrolysin (20 of 667 versus 8 of 668). Risk of bias was judged high for attrition in five trials and for selective reporting in four, and the manufacturer supported three of the trials. The review has since been updated. 34
The CARS trial randomized 208 stroke patients to Cerebrolysin or placebo alongside rehabilitation and reported better upper-limb function on the Action Research Arm Test at 90 days. It was manufacturer-funded. 6
In moderate to severe traumatic brain injury, a prospective meta-analysis of the two CAPTAIN trials (185 patients) found a small-to-medium effect in favour of Cerebrolysin on a composite of functional and neuropsychological scales at 30 and 90 days, with similar safety in both arms. 2
A separate Cochrane review covers Cerebrolysin in vascular dementia. The 2021 narrative review that counted use in over 50 countries also noted that several clinical studies found minor clinical relevance and no significant advantage over placebo. 51
| Study | Model | Finding |
|---|---|---|
| Cochrane review, acute ischaemic stroke | Humans, 6 RCTs, n=1,501, systematic review and meta-analysis | No difference in deaths; non-fatal serious adverse events more common with Cerebrolysin. 3 |
| CARS trial | Humans, n=208, randomized placebo-controlled, stroke rehabilitation | Better arm function on the Action Research Arm Test at day 90. 6 |
| CAPTAIN I and II meta-analysis | Humans, n=185, two randomized placebo-controlled trials in traumatic brain injury | Small-to-medium composite benefit at days 30 and 90, similar safety. 2 |
| Narrative review, 2021 | Literature review across stroke, neurodegeneration and brain injury | Used in over 50 countries; clinical results inconsistent, some trials no better than placebo. 1 |
Safety
In the pooled stroke trials, the total number of people with any adverse event was the same in both arms (308 of 667 versus 307 of 668), but non-fatal serious adverse events were about 2.5 times more frequent with Cerebrolysin. The CAPTAIN trials reported comparable tolerability. Reported effects include agitation, dizziness, headache and injection-site reactions. 32
The unknowns are the ones that come with an undefined animal-tissue extract: batch-to-batch consistency, immunogenicity with repeated courses, and the provenance of vials bought outside a regulated pharmacy. None of the cited trials address these. 3
Questions for your clinician
- Why did the pooled stroke trials find no effect on death or dependence?
- What does the higher rate of serious adverse events mean for someone like me?
- Is the product I would receive made to a consistent standard?
Questions people ask
Does Cerebrolysin have US regulatory approval?
No. It has never been approved in the United States for any indication. It is licensed in more than 50 other countries. 13
Can a US doctor prescribe it?
Not as an approved drug. There is no FDA-approved Cerebrolysin product, so there is nothing for a US pharmacy to dispense. Vials sold online are imported pharmaceutical product of uncertain handling. 1
What were the Cochrane review's conclusions on stroke patients?
In six randomized trials with 1,501 stroke patients, Cerebrolysin did not reduce deaths and was associated with more non-fatal serious adverse events. Reviewers rated the risk of bias high in several trials, three of which were manufacturer-supported. 3
Why is it approved in so many countries if the evidence is uncertain?
It was licensed decades ago in markets with different evidence standards at the time, and it has stayed on those markets while the controlled-trial record accumulated. The trials that show benefit are small and mostly company-backed; the independent synthesis is neutral to negative. 13
How is Cerebrolysin different from a peptide supplement?
It is a prescription pharmaceutical extract of pig brain containing many undefined peptides and amino acids, given by injection in a clinical setting abroad. It is not a single synthetic peptide and is not sold as a research chemical. 3
Citations
- 2021, Neurol Sci: Cerebrolysin for stroke, neurodegeneration and TBI, review pubmed.ncbi.nlm.nih.gov
- 2021, Neurol Sci: prospective meta-analysis of the CAPTAIN trials in TBI pubmed.ncbi.nlm.nih.gov
- Ziganshina 2017, Cochrane: Cerebrolysin for acute ischaemic stroke pubmed.ncbi.nlm.nih.gov
- Cochrane CD007026, latest update: Cerebrolysin for acute ischaemic stroke doi.org
- Cochrane CD008900: Cerebrolysin for vascular dementia doi.org
- Muresanu 2016, Stroke: Cerebrolysin and recovery after stroke (CARS) pmc.ncbi.nlm.nih.gov
- 2014, Kaohsiung J Med Sci: neuroprotective properties of Cerebrolysin doi.org
- 2006, Acta Neuropathol: anti-apoptotic effects of Cerebrolysin in experimental models doi.org
- Springer chapter: Cerebrolysin and excitotoxic neuronal damage doi.org