Cerebrolysin

FPF-1070

Rank#999
CognitiveNot ApprovedApprovedMixedIMIV

Popular for:Neuroprotection, stroke recovery, dementia, TBI

621

Total Studies

321

Human Studies

Approved

Evidence Level

Not Approved

FDA Status

Overview

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.

Mechanism of Action

Cerebrolysin contains low-molecular-weight peptides that mimic the effects of naturally occurring neurotrophic factors including BDNF, GDNF, NGF, and CNTF. These peptides cross the blood-brain barrier and support neuronal survival, synaptogenesis, neuroplasticity, and neurogenesis. The multi-target mechanism addresses multiple aspects of neurodegeneration simultaneously.

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

621

Total Studies

321

Human Studies

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 Studies / PubMed References

621 studies found on PubMed · showing top 25 by relevance

View all on PubMed

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

Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion in Anterior Circulation: Results of a 3-Month Follow-up of a Prospective, Open Label, Single-Center Study.

Human Study

Staszewski J, Dębiec A, Strilciuc S, et al. · Translational stroke research · 2025

PMID: 40325343

Is Cerebrolysin Useful in Psychiatry Disorders?

Review

Florek S, Główczyński P, Badura-Brzoza K, et al. · Biomedicines · 2025

PMID: 40722733

Cost-effectiveness of Cerebrolysin as an add-on treatment for neurorecovery after traumatic brain injury.

Human Study

Strilciuc S, Grad DA, Vlădescu C, et al. · Journal of medicine and life · 2025

PMID: 40405935

Current neuroprotective agents in stroke.

Review

Yanık T, Yanık B · Turkish journal of physical medicine and rehabilitation · 2024

PMID: 38948647

Side Effects & Safety

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.

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. Cerebrolysin is not approved by the FDA for human therapeutic use. Always consult a qualified healthcare professional before making any health-related decisions. The studies referenced are linked to their original PubMed sources for verification.