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CognitiveLimited human evidence

Cerebrolysin

Mixture of low-molecular-weight peptides and free amino acids derived from porcine brain tissue (NOT a single defined peptide — a complex bioactive mixture). Approved in many European, Asian, and Latin American countries for stroke recovery, traumatic brain injury, and Alzheimer's disease. NOT FDA-approved in the US.

Educational only — not medical advice. SmartPeptide does not prescribe, diagnose, or treat. Always consult a licensed healthcare provider before using any peptide, supplement, medication, or protocol.

What the research shows

Multiple RCTs in stroke and TBI populations show modest functional improvements; Cochrane reviews have been mixed (some positive, some inconclusive). Approved use in Europe / Asia / Latin America. Alzheimer's data shows small symptom benefits at best.

What's still experimental

Use outside approved indications. Optimal dosing protocols, treatment duration, and combination with standard rehabilitation are still being refined. US clinical access is essentially zero.

Anecdotal / community reports

Nootropic communities import Cerebrolysin for general cognitive enhancement. These uses are not supported by RCT data in healthy adults and add the risk of unverified product quality.

Anecdotal reports are NOT scientific evidence. They reflect personal experience and may not generalize.

FDA approval status

Source: openFDA + DailyMed (NIH/NLM)
No FDA-approved drug label exists for “Cerebrolysin”. This peptide is not currently approved by the FDA as a finished pharmaceutical product. Any commercial product claiming FDA approval should be treated with suspicion.

Doses studied in research

No established dose range

What published trials tested or FDA-approved labels specify. Reporting research facts — not a SmartPeptide recommendation.

No FDA-approved or established trial dose range for this peptide. Anecdotal ranges discussed in community forums exist but are not supported by published clinical trials, and SmartPeptide will not publish unverified doses.

This is the honest answer for peptides like BPC-157, IGF-1 LR3, MOTS-c, Epitalon and similar research compounds — robust human dose- ranging studies have not been published. Always work with a licensed clinician familiar with experimental peptides if you are considering any use.

FDA enforcement & recalls

Live · openFDA Drug Enforcement API
Total actions
2
recalls + withdrawals
Ongoing
2
not yet completed
Class I (serious)
0
health hazard / death risk
  • Class IIOngoing· Voluntary: Firm initiated
    FDA record

    Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

    Reason: Lack of Assurance of Sterility

    Jul 30, 2025·GenoGenix LLC
  • Class IIOngoing· Voluntary: Firm initiated
    FDA record

    CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

    Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

    Nov 30, 2020·Advanced Nutriceuticals, LLC
FDA classifications: Class I = reasonable probability of serious adverse health consequences or death. Class II = temporary or medically reversible adverse consequences. Class III = unlikely to cause adverse health consequences.

Mechanism & targets

ChEMBL · UniProt · Open Targets
No mechanism data indexed in ChEMBL, UniProt, or Open Targets for “Cerebrolysin”. This is common for unscheduled research peptides that haven't been studied in structured target-binding assays.

Live research

PubMed · ClinicalTrials.gov · Europe PMC · OpenAlex
PubMed papers
665
total
Human studies
0
MeSH: humans
Clinical trials
0
published
Active trials
4
42 total registered

Clinical trials (ClinicalTrials.gov)

All trials for "cerebrolysin"

Europe PMC — 1,169 additional records

Includes EU/UK studies and PubMed Central full-text articles. Often surfaces research weeks before PubMed indexes it.

Research volume (OpenAlex topic graph)

Total works
2,915
all years
Last 5 years
1,242
recent activity
Open access
2,019
freely readable
OA share
69%
of all works

Human clinical evidence

Semantic Scholar · AI TLDRs · influence-ranked
Semantic Scholar API is currently rate-limited.

Human-study summaries for “cerebrolysin” are available on Semantic Scholar but the shared free-tier API quota is exhausted right now. Try refreshing in a few minutes, or check the PubMed and Europe PMC panels above for the same literature.

Research funding & verification

NIH RePORTER · CrossRef DOI registry

NIH-funded research

U.S. National Institutes of Health
Funded projects
3
all years
Top award sum
$503K
aggregate USD
Years covered
11
research span
Largest active / recent grants

Publication landscape

CrossRef · DOI registry
Indexed works (CrossRef)
575
all DOIs registered
Retracted papers
0
no retractions on record
Top funders of indexed research
  • University Grants Commission12 works
  • U.S. Air Force12 works
  • Medicinska Forskningsrådet12 works
  • European Office of Aerospace Research and Development12 works
  • Air Force Office of Scientific Research12 works
  • Air Force Materiel Command12 works

Funder diversity is a credibility signal. Research concentrated in a single drug company's funding warrants more scrutiny than research funded across NIH, charities, and academic grants.

Preprints — cutting edge

bioRxiv · medRxiv · via Europe PMC

Preprints have NOT been peer-reviewed. They are early research shared by authors before formal validation. Treat findings as preliminary.

Showing 6 of 13 preprints indexed by Europe PMC.

Known risks

Generally well-tolerated in approved use. Hypersensitivity reactions possible (porcine source). Theoretical prion-transmission concerns historically discussed but no documented cases. Quality / sourcing of grey-market product is a serious concern.

Reported side effects

Injection-site reactions, occasional flushing, headache, nausea. Acute hypersensitivity rare but documented.

FDA adverse event reports (FAERS)

Updated quarterly by FDA
Reports filed
78
FAERS, all years
Serious reports
73
94% of reports
Top reporting countries
  • EG21
  • RO10
  • PL7
  • AT5

Most-reported reactions

  • Drug Ineffective
    12
  • Tremor
    8
  • Cognitive Disorder
    7
  • Depression
    7
  • Pyrexia
    7
  • Diarrhoea
    6
  • Dyspnoea
    6
  • Multiple Sclerosis Relapse
    6
  • Pain In Extremity
    6
  • Urinary Incontinence
    6

Counts from FDA Adverse Event Reporting System (FAERS). Voluntary reports — they show what was reported, not whether the drug caused the event. Many reports lack confirmation. FAERS docs

What requires medical supervision

Approved indications require prescriber-supervised administration. Outside approved indications, work with a clinician familiar with the literature.

Questions for your clinician

  • Do I have an indication (post-stroke, TBI, vascular dementia) where Cerebrolysin has demonstrated benefit?
  • What does our local rehabilitation protocol look like vs. adding Cerebrolysin?
  • What's the sourcing concern with imported product?

Editorially curated references

Discussions about Cerebrolysin

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