Cerebrolysin

FPF-1070

CognitiveNot ApprovedApprovedMixedIMIV

Popular for:Neuroprotection, stroke recovery, dementia, TBI

42

Registered Trials

91

Trial Publications

624

PubMed References

Approved

Evidence Level

Overview

Cerebrolysin is a peptide preparation derived from purified porcine brain tissue, containing a mixture of neurotrophic peptides and amino acids. The short version: people usually care about it for neuroprotection, stroke recovery, dementia, tbi, but the strength of the evidence depends heavily on indication and study type.

Cerebrolysin is a peptide preparation derived from purified porcine brain tissue, containing a mixture of neurotrophic peptides and amino acids. It has been approved as a pharmaceutical in over 40 countries (primarily in Europe, Asia, and Latin America) for the treatment of stroke, traumatic brain injury, and dementia.

Developed by EBEWE Pharma (now part of EVER Pharma) in Austria, Cerebrolysin has been studied in numerous clinical trials involving thousands of patients. It is one of the few peptide-based neurotherapeutics with extensive human clinical data, though it is not FDA-approved in the United States.

Research Snapshot

What the evidence says

Approved

Cerebrolysin currently shows 42 registered trials from ClinicalTrials.gov, 91 PubMed trial publications (63 RCT-tagged), and 624 PubMed references matching the stored source query. Treat PubMed references as literature surface area, not a count of clinical trials.

Known vs uncertain

Known signals

  • 42 registered trials are tracked from ClinicalTrials.gov intervention records.
  • 91 PubMed clinical-trial publications are indexed.
  • 63 PubMed randomized controlled trial publications are indexed.
  • 624 PubMed references are tracked separately from trial counts and can include animal, in-vitro, review, mechanism, or clinical records.

Open questions

  • Evidence strength may vary by indication, route, formulation, and population.
  • Public anecdotes can highlight interest or concern but do not establish clinical efficacy.
  • Regulatory status and compounding access can change independently from the research literature.

Mechanism of Action

Cerebrolysin contains low-molecular-weight peptides that mimic the effects of naturally occurring neurotrophic factors including BDNF, GDNF, NGF, and CNTF.

Key Research Benefits

Approved in 40+ countries for stroke and TBI
Extensive human clinical trial data (thousands of patients)
Studied for Alzheimer's disease and vascular dementia
Multi-target neurotrophic action
Researched for neuroplasticity and cognitive recovery
Crosses blood-brain barrier

Clinical Evidence Summary

Research Pipeline

Preclinical
Animal
Phase I
Phase II
Phase III
Approved

International Regulatory Status

🇷🇺
RussiaApproved1970(Cerebrolysin)

Stroke, traumatic brain injury, dementia, Alzheimer's disease

Source
🇪🇺
EUApproved1975(Cerebrolysin)

Stroke, dementia, traumatic brain injury

Source
🇨🇳
ChinaApproved1997(Cerebrolysin)

Stroke, vascular dementia, traumatic brain injury

Source

42

Registered Trials

91

Trial Publications

63

RCT Publications

624

PubMed References

ClinicalTrials.govPubMed ESearchExact-name queryChecked May 3, 2026

Registered trials are ClinicalTrials.gov intervention records. Trial publications are PubMed records tagged as clinical trials or randomized controlled trials. PubMed references are broader source-query matches and can include animal studies, in-vitro work, reviews, mechanism papers, and trial publications.

42

Registered trials

91

Trial publications

63

RCT publications

624

PubMed references

95

Reviews

19

Meta-analyses

Registered trials source

Jun 1, 2026

Cerebrolysin

Uses the exact compound name as a ClinicalTrials.gov intervention query.

View source

Publication counts source

May 3, 2026

Cerebrolysin

Uses the exact display name.

View source

Approved in 40+ countries (Europe, Asia, Latin America). NOT FDA-approved in the US. Available as pharmaceutical in approved countries, research compound in US.

Key PubMed References

624 PubMed references · showing top 25 by relevance

View all on PubMed

Cerebroprotection in acute ischemic stroke: Perspectives on combining cerebrolysin with recanalization therapy.

Review

Ribó M, Staszewski J, Zeiler SR, et al. · Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2026

PMID: 41349847

Combined citicoline and Cerebrolysin for neuroprotection in traumatic brain injury: a retrospective cohort analysis.

Human Study

Schlager P, Grgac I, Herzer G, et al. · Frontiers in neurology · 2025

PMID: 41409218

C-REGS2-A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke.

Human Study

Vosko MR, Sanak D, Do Y, et al. · International journal of stroke : official journal of the International Stroke Society · 2025

PMID: 40851188

Speech Therapy Combined With Cerebrolysin in Enhancing Nonfluent Aphasia Recovery After Acute Ischemic Stroke: ESCAS Randomized Pilot Study.

Human Study

Homberg V, Jianu DC, Stan A, et al. · Stroke · 2025

PMID: 39957612

Effects of cerebrolysin on behavioral changes and the tryptophan-kynurenine pathway in the prefrontal cortex of male mice in the ketamine model of schizophrenia.

Animal Study

Mafikandi V, Hosseini L, Seyedaghamiri F, et al. · Molecular biology reports · 2025

PMID: 40668305

Anecdotes & Sentiment

Public discussion, not clinical evidence

This section summarizes what people are talking about in public sources. It can be useful for spotting questions, hype cycles, and recurring concerns, but it is separate from the evidence sections above.

No curated public-discussion themes are live for Cerebrolysin yet.

Side Effects & Safety

- Dizziness - Headache - Injection site reactions - Agitation or insomnia (uncommon) - Nausea - Must be administered IM or IV (no oral formulation)

Dizziness
Headache
Injection site reactions
Agitation or insomnia (uncommon)
Nausea
Must be administered IM or IV (no oral formulation)

Known Interactions

No curated interaction entry is live for Cerebrolysin yet.

Until the interaction table is fully populated, use the interaction checker and related peptides below to explore adjacent compounds and likely research pairings.

Comparison Pages

Comparison pages

All

No comparison page is linked yet.

Frequently Asked Questions

Research Disclaimer

This page is for research and educational purposes only. The information presented is based on published scientific literature and does not constitute medical advice, diagnosis, or treatment recommendations. Regulatory status can vary by compound, formulation, indication, and jurisdiction. Check official labeling, registry records, and qualified professional guidance before making any health-related decision. The studies referenced are linked to their original PubMed sources for verification.