Peptide Evidence Index

Cerebrolysin

Evidence last reviewed: September 2026

Quick answers

What is it?
Cerebrolysin is a mixture of low-molecular-weight peptides and free amino acids made by enzymatically breaking down pig (porcine) brain tissue, given by injection or IV infusion. It is manufactured by the Austrian company Ever Neuro Pharma and is not a single defined peptide.
Why are people interested in it?
It has by far the largest human trial record of any compound in this library, 42 registered trials across stroke, dementia, Alzheimer's disease and more, so people want to know whether that volume of research actually shows a benefit.
What has actually been studied?
Dozens of randomized, placebo-controlled trials, including a 1,070-patient acute stroke trial (CASTA) and Cochrane systematic reviews of stroke and vascular dementia evidence, plus smaller trials in Alzheimer's disease and post-stroke language recovery.
How strong is the evidence?
Mixed and contested. Independent Cochrane reviews found little or no benefit on hard outcomes like death, plus a signal for more serious side effects, while manufacturer-linked and some independent meta-analyses reported modest benefits on cognitive or functional scores.
What don't we know yet?
Whether the modestly positive pooled results replicate independently of the manufacturer's own trial network, and why over 40 registered trials across two decades have not led to FDA or EU approval.
Where can I read the original research?
Sources at the bottom of this page: Ziganshina et al., Cochrane Database of Systematic Reviews 2020; Heiss et al., Stroke 2012 (the CASTA trial).

Plain-English overview

Cerebrolysin is a mixture of low-molecular-weight peptides and free amino acids produced by enzymatically breaking down porcine (pig) brain tissue, and is given as an intravenous or intramuscular infusion. It is manufactured by the Austrian company Ever Neuro Pharma and, unlike most other entries in this library, is not a single defined synthetic peptide but a biological tissue extract. It has the largest clinical-trial footprint of any compound reviewed here, 42 trials registered on ClinicalTrials.gov spanning acute stroke, vascular dementia, Alzheimer's disease, traumatic brain injury, and a number of smaller and more unusual indications. The evidence is genuinely split: independent Cochrane systematic reviews report little or no benefit on hard outcomes such as death, alongside a signal for more serious side effects, while other meta-analyses, some linked to the manufacturer and some independent, report modest benefits on cognitive and functional measures. It is not approved by the FDA in the United States, though Cochrane describes it as widely used clinically in Russia, China, and other Eastern European and Asian countries.

What researchers are studying it for

Current evidence level

Mixed human evidence

Regulatory status: Not an approved medicine. Evidence strength and approval are scored separately; approval is a regulatory decision about a specific use, not a measure of how much research exists.

Human research

Forty-two trials of Cerebrolysin are registered on ClinicalTrials.gov, the largest number for any compound in this library, spanning acute ischemic and hemorrhagic stroke, vascular dementia, Alzheimer's disease, traumatic brain injury, cerebral palsy, Down syndrome, Bell's palsy, and post-COVID-19 smell and taste loss, among others. The largest and most rigorous is CASTA (Cerebrolysin in Asian Stroke Trial, NCT00868283), a multicenter, double-blind, placebo-controlled trial that enrolled 1,070 patients with acute ischemic stroke across sites in China, Hong Kong, and South Korea and gave 30 mL of Cerebrolysin or saline daily for 10 days; published in Stroke in 2012, its confirmatory primary endpoint, a combined measure of disability and stroke-severity scales, showed no significant difference from placebo, though a post-hoc subgroup of the most severely affected patients showed a mortality trend favoring Cerebrolysin (10.5% versus 20.2% on placebo) that was never confirmed in a follow-up trial. A 2020 Cochrane review of 7 randomized trials and 1,601 stroke patients found Cerebrolysin "probably has little or no beneficial effect" on preventing death and flagged a potential increase in non-fatal serious adverse events. A separate 2019 Cochrane review of Cerebrolysin for vascular dementia, covering 6 trials and 597 patients, called the supporting evidence "weak" and rated it "very low-quality," despite pooled results favoring Cerebrolysin on cognitive test scores. By contrast, other meta-analyses, including a 2015 analysis with authors affiliated with manufacturer-linked biometry firms, reported significant cognitive benefit in mild-to-moderate Alzheimer's disease, while an independent 2017 Chinese academic meta-analysis of overlapping stroke-trial data concluded that "routine use of cerebrolysin... could not be supported by available evidence." A 2022 umbrella review grouped Cerebrolysin with acetylcholinesterase inhibitors and Ginkgo biloba as showing benefit in Alzheimer's disease, while a larger 2025 meta-analysis covering 173 trials and over 22,000 participants across vascular cognitive impairment interventions found Cerebrolysin among several agents with "small to moderate improvements in cognition," smaller than the effect the same review found for Ginkgo biloba extract. The single most positive individual result is a 2025 pilot trial (ESCAS) of 123 patients with post-stroke language loss across two Romanian centers, where adding Cerebrolysin to speech therapy produced a statistically significant 14.8-point greater improvement on a standardized language test than speech therapy plus placebo, a genuinely positive result, but from a single pilot-scale trial not yet replicated at larger scale.

Animal and preclinical research

Cerebrolysin's neurotrophic and neuroprotective claims were originally supported by animal-model studies of cerebral ischemia (stroke) rather than human data. This review's sourcing centers on the extensive human trial record rather than a distinct, separately citable animal efficacy literature.

Major findings

What has not been established

Important limitations

Regulatory status

Cerebrolysin is manufactured by the Austrian company Ever Neuro Pharma. It is not approved by the FDA in the United States. Cochrane's reviews describe it as widely used clinically in Russia, China, and other Eastern European and Asian countries, despite the absence of U.S. or EU approval.

Primary research sources

Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z, "Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial" (CASTA)
Stroke 2012;43(3):630-6; PMID 22282884
Hong Z, Moessler H, Bornstein N, Brainin M, Heiss WD, "A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with acute ischaemic stroke in Asia--CASTA"
International Journal of Stroke 2009;4(5):406-12; PMID 19765131
Ziganshina LE, et al., "Cerebrolysin for acute ischaemic stroke"
Cochrane Database of Systematic Reviews 2020; PMID 32662068, DOI 10.1002/14651858.CD007026.pub6
Cui J, et al., "Cerebrolysin for vascular dementia"
Cochrane Database of Systematic Reviews 2019; PMID 31710397, DOI 10.1002/14651858.CD008900.pub3
Gauthier S, et al., "Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials"
Dementia and Geriatric Cognitive Disorders 2015; PMID 25832905, DOI 10.1159/000377672
Zhang D, Dong Y, Li Y, Chen J, Wang J, Hou L, "Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials"
BioMed Research International 2017; PMID 28656143, DOI 10.1155/2017/4191670
Fan F, Liu H, Shi X, Ai Y, Liu Q, Cheng Y, "The Efficacy and Safety of Alzheimer's Disease Therapies: An Updated Umbrella Review"
Journal of Alzheimer's Disease 2022;85(3):1195-1204; PMID 34924395, DOI 10.3233/JAD-215423
Masserini F, Gendarini C, Baso G, Salvadori E, Pantoni L, "Therapeutic strategies in vascular cognitive impairment: A systematic review and meta-analysis"
Alzheimer's & Dementia 2025;21(11):e70840; PMID 41198594, DOI 10.1002/alz.70840
Homberg V, Jianu DC, Stan A, et al., "Speech Therapy Combined With Cerebrolysin in Enhancing Nonfluent Aphasia Recovery After Acute Ischemic Stroke: ESCAS Randomized Pilot Study"
Stroke 2025;56(4):937-947; PMID 39957612, DOI 10.1161/STROKEAHA.124.049834
Full evidence entry (complete data, registry records, dosing evidence)
Mixed human evidence
Controlled human trials exist and disagree

At a glance

Also known as
Cerebrolysin, FPF-1070, Cerebrolysine
Class
Porcine-brain-derived peptide and amino-acid mixture
Derived from
An enzymatic digest of porcine (pig) brain tissue, yielding a mixture of low-molecular-weight peptides and free amino acids — not a single defined peptide sequence
Registered human trials
42
…with published results
At least 2 of 42 confirmed to have posted results directly on ClinicalTrials.gov (not all 42 individually checked); many pivotal trials are published only in peer-reviewed journals and Cochrane reviews rather than as CT.gov results records.
Largest human trial
1,071 patients (the CASTA trial, Phase 4, 2006–2011) — a randomized, double-blind, placebo-controlled ischemic-stroke trial conducted at sites in China, Hong Kong, and South Korea; completed, no results posted on ClinicalTrials.gov.
Studied for
acute ischemic stroke, vascular dementia, Alzheimer's disease, traumatic brain injury, post-COVID smell/taste loss, cerebral palsy / neonatal brain injury, Down syndrome
Dosing evidence
Doses used in trialsMultiple randomized, placebo-controlled trials used defined intravenous Cerebrolysin regimens — commonly daily infusions for one to three weeks — in stroke, dementia, and Alzheimer's patients, but Cochrane's independent reviews found the resulting evidence on hard outcomes weak and flagged more non-fatal serious adverse events with use.
Regulatory status
Manufactured by the Austrian company Ever Neuro Pharma. Not approved by the FDA in the United States. Cochrane's own reviews describe it as widely used clinically in Russia, China, and other Eastern European and Asian countries.

What it is

Cerebrolysin is a mixture of low-molecular-weight peptides and free amino acids made by enzymatically breaking down porcine (pig) brain tissue. It is manufactured by the Austrian company Ever Neuro Pharma and given as an intravenous or intramuscular infusion. Unlike the other entries in this library, it is not a single, defined synthetic peptide sequence — it's a biological tissue extract.

What the studies actually found

Cerebrolysin has the largest and most contested clinical-trial record of any compound in this library. Cochrane — the independent international body that produces systematic reviews of medical evidence — has published reviews on Cerebrolysin for both acute ischemic stroke and vascular dementia. The 2020 stroke review, covering 7 randomized trials and 1,601 patients, found Cerebrolysin "probably has little or no beneficial effect" on preventing death after stroke, and flagged a "potential increase in non-fatal serious adverse events" among Cerebrolysin-treated patients. The vascular-dementia review, covering 6 trials and 597 patients, called the supporting evidence "weak" and rated it "very low-quality."

Separately, other meta-analyses — some with authors affiliated with or contracted to the manufacturer, Ever Neuro Pharma — have reported significant benefit: for stroke-related motor recovery, for cognitive scores in mild-to-moderate Alzheimer's disease, and for traumatic brain injury outcomes. Meanwhile, independent academic meta-analyses run by groups in China, using overlapping published stroke-trial data, concluded the opposite — that "routine use of cerebrolysin... could not be supported by available evidence."

This is not a case of no evidence. It's a case of real, randomized trials whose pooled conclusions differ depending, in part, on who ran the analysis.

What exists in humans

42 trials are registered on ClinicalTrials.gov — far more than any other compound in this library. They span acute stroke, vascular dementia, Alzheimer's disease, traumatic brain injury, cerebral palsy, neonatal brain injury, Down syndrome, Bell's palsy, post-COVID smell and taste loss, and even hair repigmentation. The largest is a 1,071-patient double-blind ischemic-stroke trial (CASTA) that ran across dozens of hospitals in China, Hong Kong, and South Korea; it is completed but has not posted results on ClinicalTrials.gov. Two other large, completed Ever Neuro Pharma-sponsored trials — a 242-patient vascular-dementia study in Russia and a 217-patient Alzheimer's combination-therapy study in Spain — have posted results directly on the registry. Across the 42 registered trials, sponsors and sites span Russia, China, Poland, South Korea, Egypt, Mexico, Taiwan, Slovenia, Croatia, Israel, and Austria (where the manufacturer is based); none in this dataset is sponsored by, or appears to run at, a U.S. site.

What doses have been studied in humans

Cerebrolysin is the exception in this library: it has real efficacy trials with clearly reported intravenous dosing regimens, not just safety studies.

The pivotal ischemic-stroke trials gave Cerebrolysin (or a saline placebo) once daily by intravenous infusion for roughly 10 to 21 days, started within 72 hours of stroke onset, most commonly at 30 mL per day (some trials used up to 50 mL per day). The vascular-dementia trials generally used repeated 4-week infusion courses at 20–30 mL per day. The Alzheimer's combination-therapy trial gave 10 mL per day, alongside or against the cholinesterase-inhibitor drug donepezil.

These are real, repeated regimens tested against placebo in randomized, blinded trials — not internet-forum extrapolations. But an administered amount is not the same as a proven effective one: Cochrane's independent reviews of much of this same trial evidence found little or no benefit on hard outcomes like death, alongside a signal for more non-fatal serious adverse events at higher cumulative doses. So while the dosing itself is well documented, what it reliably accomplishes remains disputed. All of this dosing evidence comes from intravenous or intramuscular administration in hospital settings — none of it describes how Cerebrolysin-branded products might be used outside a clinical setting.

What remains unknown

  • Whether Cerebrolysin has a real effect on hard outcomes (death, long-term disability) beyond softer cognitive or rating-scale measures
  • Why manufacturer-linked and independent analyses of overlapping trial data reach different conclusions
  • Whether the signal for more non-fatal serious adverse events in the Cochrane stroke review reflects a real risk
  • Why, despite more than 40 registered trials over two decades, no U.S. or EU regulatory approval has followed

Registry and study records

Cerebrolysin for acute ischaemic stroke
PubMed / Cochrane · Ziganshina et al., Cochrane Database Syst Rev, 2020. 7 RCTs, 1,601 patients. 'Probably... little to no difference in all-cause death'; flagged a potential increase in non-fatal serious adverse events. DOI: 10.1002/14651858.CD007026.pub6
Cerebrolysin for vascular dementia
PubMed / Cochrane · Cui et al., Cochrane Database Syst Rev, 2019. 6 RCTs, 597 patients. Called supporting evidence 'weak' and rated it 'very low-quality.' DOI: 10.1002/14651858.CD008900.pub3
Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials
PubMed · Gauthier et al., 2015. Reported significant cognitive/global benefit; co-authors are affiliated with manufacturer-linked biometry firms. DOI: 10.1159/000377672
Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials
PubMed · Zhang et al., 2017 (independent, Chinese academic group). 'Routine use of cerebrolysin... could not be supported by available evidence.' DOI: 10.1155/2017/4191670
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke (CASTA)
ClinicalTrials.gov NCT00868283 · n=1,071, completed 2011, sites in China/Hong Kong/South Korea, no results posted on the registry

Articles on Cerebrolysin

What has Cerebrolysin actually been tested for in clinical trials, andCerebrolysin: What Has Actually Been Trialled?
See the full Evidence Index →

Topic hubs

TopicBrain & Cognitive Health

Evidence last reviewed: September 2026. Peptide Proof reports what studies found. We do not give medical advice, dosing guidance, or treatment recommendations.