Cerebrolysin
Research OnlyCerebrolysin is a porcine brain-derived peptide mixture approved in 50+ countries for stroke, dementia, and traumatic brain injury. It is NOT FDA-approved in the United States despite decades of international clinical use. Contains neurotrophic peptide fragments mimicking BDNF, GDNF, NGF, and CNTF. Mixed Phase 3 results but positive meta-analyses and widespread adoption in Europe, Asia, and Latin America.
FPF-1070 · N-PEP-12 · Renacenz
22 human studies
- Preclinical
- 31%
- Clinical
- 69%
Based on 32 cited sources
clinically demonstrated · low confidence
Demonstrated effect magnitude — not a recommendation or safety claim.
Research depth: multiple RCTs plus Cochrane systematic reviews and a 6-RCT Alzheimer's meta-analysis, but the largest stroke trial (CASTA, N=1070) missed its primary endpoint and most trials are manufacturer-sponsored. Mechanism: neurotrophic (BDNF/NGF/GDNF-mimetic), sonic-hedgehog and PI3K/Akt pathways are characterized in vivo but the active components of the mixture remain undefined. Plausibility: claimed cognitive/motor benefits follow coherently from neurotrophic and neurogenesis biology with class analogy. Global coverage: studied across 50+ countries with independent replication and multi-regulator approval. Community experience: limited niche enthusiast discussion, no notable recurring adverse signal. Effectiveness basis is clinical (quantified human estimates: CARS day-90 ARAT Mann-Whitney 0.71, AD meta-analysis OR 3.32) but magnitude is modest, mixed across endpoints, and Cochrane found no convincing stroke mortality/dependence benefit, so confidence is low.
Cerebrolysin is a porcine brain-derived peptide mixture used in 50+ countries for stroke, dementia, and traumatic brain injury — but it is not FDA-approved in the United States. For regulatory context, see our FDA approval glossary entry and regulatory tracker.
Mechanism of Action
Cerebrolysin is a complex mixture of porcine brain-derived peptide fragments and free amino acids. Its proposed mechanisms are supported by both preclinical studies and multiple Phase 3 clinical trials, though the exact active components remain to be fully characterized.
How It Works (Simplified)
Cerebrolysin contains small protein fragments that mimic natural brain growth factors (neurotrophins), providing multimodal neuroprotective and neurorestorative support:
Peptide fragments mimic BDNF, NGF, GDNF, and CNTF, activating TrkB and TrkA receptors to promote neuronal survival and synaptic plasticity.
Activates sonic hedgehog pathway, stimulating neural progenitor proliferation in hippocampus and promoting new neuron formation.
Protects neurons from glutamate excitotoxicity, ischemia, and oxidative stress through PI3K/Akt survival pathway activation.
Promotes oligodendrocyte function and white matter repair, supporting recovery of neural connectivity after stroke or injury.
Key Research: CARS trial (Muresanu DF et al. 2015) demonstrated significant upper-limb motor recovery (day-90 Action Research Arm Test, Mann-Whitney 0.71) in stroke patients. PMID:26564102. Alzheimer’s meta-analysis (Gauthier S et al. 2015) showed OR 3.32 for global clinical improvement across 6 RCTs. PMID:25832905
Important Limitations
- Largest stroke trial (CASTA, N=1070) failed primary endpoint - benefit only in severe subgroup [PMID:22282884]
- Cochrane reviews conclude “no convincing evidence” for mortality/dependence reduction in stroke
- Complex mixture composition makes identifying active components difficult
- Not FDA-approved despite 50+ country approvals - no NDA filed
- Most trials manufacturer-sponsored (EVER Neuro Pharma)
- Russian and Chinese primary literature not fully accessible in English
| NCT ID | Title | Peptide | Phase | Status | Completion |
|---|---|---|---|---|---|
| NCT00833248 | Cerebrolysin and Recovery After Stroke (CARS) | Cerebrolysin | Phase 4 | Completed | - |
| NCT01822860 | Cerebrolysin and Recovery After Stroke 2 (CARS2) | Cerebrolysin | Phase 4 | Completed | - |
| NCT00715026 | Cerebrolysin Acute Stroke Treatment in Asia (CASTA) | Cerebrolysin | Phase 3 | Completed | - |
| NCT00728182 | Cerebrolysin in Vascular Dementia | Cerebrolysin | Phase 3 | Completed | - |
| NCT00216502 | Cerebrolysin in Moderate Alzheimer's Disease | Cerebrolysin | Phase 3 | Completed | - |
| NCT01819545 | E-CARS Extension Study | Cerebrolysin | Phase 4 | Completed | - |
| NCT06899464 | Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial Intracerebral Hemorrhage, Hemorrhagic Stroke, Intracerebral +2 more | Cerebrolysin | Phase 4 | Not yet recruiting | Jan 2027 |
| NCT07043686 | Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study Ischemic Stroke, Acute, Rehabilitation Outcome +1 more | Cerebrolysin | Phase N/A | Recruiting | Jul 2027 |
| NCT06897176 | Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study Stroke | Cerebrolysin | Phase 4 | Recruiting | Jun 2025 |
| NCT06489925 | Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion Basilar Artery Occlusion, Posterior Circulation Brain Infarction | Cerebrolysin | Phase 1 | Not yet recruiting | May 2025 |
| NCT06339411 | Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights Acute Ischemic Stroke | Cerebrolysin | Phase 1 | Not yet recruiting | Dec 2026 |
| NCT06677502 | Cerebrolysin in Critically Ill Patients With Delirium Cognitive Impairment | Cerebrolysin | Phase N/A | Recruiting | Jun 2025 |
| NCT05755997 | CERebrolysin In CADASIL Cadasil | Cerebrolysin | Phase 2 | Active | Mar 2026 |
| NCT06070753 | A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT) Acute Ischemic Stroke | Cerebrolysin | Phase N/A | Unknown | Jun 2024 |
| NCT06052787 | Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU Traumatic Brain Injury | Cerebrolysin | Phase 3 | Completed | May 2025 |
| NCT05821075 | Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy Bell Palsy | Cerebrolysin | Phase 1/2 | Recruiting | Jan 2026 |
| NCT04427241 | Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness Disorder of Consciousness, Hemorrhagic Stroke | Cerebrolysin | Phase 4 | Recruiting | Sep 2026 |
| NCT05864677 | Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery Neurocognitive Disorders, Surgery-Complications +3 more | Cerebrolysin | Phase N/A | Unknown | Jun 2024 |
| NCT06078215 | CERebrolysine Effect on Blood-brain Barrier in acUte Ischemic Stroke Acute Ischemic Stroke | Cerebrolysin | Phase 4 | Unknown | Jan 2025 |
| NCT06273020 | Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke Ischemic Stroke, Acute, Diabetes Mellitus, Type 2 +1 more | Cerebrolysin | Phase 4 | Unknown | Nov 2024 |
| NCT06208540 | Clinical Characteristics and Treatment of Anosmia and Ageusia Due to SARS-CoV2 Variants Post-covid-19 Persistent Smell and Taste Disorders | Cerebrolysin | Phase 4 | Completed | Apr 2024 |
| NCT04124367 | IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE Chronic Stroke, Subacute Stroke | Cerebrolysin | Phase 2 | Terminated | Mar 2022 |
| NCT04913831 | Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study Stroke | Cerebrolysin | Phase 4 | Unknown | Mar 2024 |
| NCT05124353 | Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT Stroke, Acute, Ischemic | Cerebrolysin | Phase 2/3 | Unknown | Apr 2023 |
| NCT04904341 | Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke. Stroke, Ischemic, Stroke, Acute +1 more | Cerebrolysin | Phase 3 | Unknown | Dec 2023 |
| NCT04830943 | Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia Covid19 Related Anosmia and Aguesia | Cerebrolysin | Phase 3 | Completed | Sep 2021 |
| NCT04751136 | the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome Down Syndrome | Cerebrolysin | Phase 2 | Completed | Feb 2019 |
| NCT03506841 | Cerebrolysin and Neurodevelopment in Preterm Infants Infant Development, Cerebral Palsy +1 more | Cerebrolysin | Phase 1 | Completed | Jun 2019 |
| NCT02768571 | Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke Stroke | Cerebrolysin | Phase 4 | Completed | Feb 2019 |
| NCT02581371 | Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm Ischemic Stroke | Cerebrolysin | Phase 4 | Unknown | Feb 2017 |
| NCT05288465 | Hair Repigmentation During Cerebrolysin Therapy Hair Problems | Cerebrolysin | Phase N/A | Completed | Dec 2015 |
| NCT02116348 | Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy Cerebral Palsy Children, Children With Traumatic Brain Injury +2 more | Cerebrolysin | Phase 2 | Unknown | Apr 2016 |
| NCT01787123 | Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin™ in Patients With Aneurysmal Subarachnoid Hemorrhage Subarachnoid Hemorrhage, Intracranial Aneurysm +2 more | Cerebrolysin | Phase 2/3 | Completed | Jan 2019 |
| NCT01606111 | The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery Traumatic Brain Injury | Cerebrolysin | Phase 4 | Terminated | Jul 2015 |
| NCT01059461 | Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy Hypoxic-Ischemic Encephalopathy | Cerebrolysin | Phase 2 | Completed | Sep 2013 |
| NCT01996761 | Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke Cerebrolysin | Cerebrolysin | Phase 4 | Completed | Jan 2014 |
| NCT01388738 | Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke. Stroke | Cerebrolysin | Phase 3 | Completed | Oct 2011 |
| NCT02149875 | Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke Acute Cerebral Stroke Within 12 Hours for the First Time | Cerebrolysin | Phase 1/2 | Completed | May 2010 |
| NCT00947531 | A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia Vascular Dementia | Cerebrolysin | Phase 4 | Completed | - |
| NCT00868283 | The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke Ischemic Stroke | Cerebrolysin | Phase 4 | Completed | Oct 2010 |
| NCT00840671 | Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke Stroke | Cerebrolysin | Phase 3 | Completed | Mar 2008 |
| NCT00911807 | Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease Alzheimer Disease | Cerebrolysin | Phase 2 | Completed | Apr 2008 |
| NCT01822951 | Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT) Alzheimer Disease | Cerebrolysin | Phase 4 | Withdrawn | Sep 2016 |
Cerebrolysin Acute Stroke Treatment in Asia (CASTA)
Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial
Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study
Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study
Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion
Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights
Cerebrolysin in Critically Ill Patients With Delirium
A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)
Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU
Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery
CERebrolysine Effect on Blood-brain Barrier in acUte Ischemic Stroke
Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke
Clinical Characteristics and Treatment of Anosmia and Ageusia Due to SARS-CoV2 Variants
IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE
Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT
Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke.
Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia
the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome
Cerebrolysin and Neurodevelopment in Preterm Infants
Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke
Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm
Hair Repigmentation During Cerebrolysin Therapy
Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy
Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin™ in Patients With Aneurysmal Subarachnoid Hemorrhage
The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke
Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease
Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)
Based on clinical trials: Initial neurotrophic signaling begins. IV administration protocols typically show early improvements in cognitive assessments. Most trials use 10-30mL daily IV infusion.
PMID:16420392The CARS stroke trial delivered its 21-day treatment course alongside early rehabilitation. Cognitive improvements in dementia trials become measurable. Sonic hedgehog pathway activation promotes ongoing neurogenesis.
PMID:26564102Sustained neuroplasticity effects. Alzheimer's trials showed continued ADAS-cog improvement through treatment period. Motor recovery in stroke continues to progress.
PMID:25832905Effects persist 3 months post-treatment in Alzheimer's studies. Long-term follow-up suggests disease-modifying potential. Treatment courses of 4-8 weeks are common in clinical practice.
Research-based observations
This timeline reflects observations from published clinical and preclinical studies. Individual responses may vary significantly. This is not a guarantee of effects or a dosing schedule. Consult qualified healthcare providers for personalized guidance.
Good Signs (6 indicators)
Warning Signs (5 indicators)
Bad Signs (6 indicators)
For Research Evaluation Only
These quality indicators are general guidelines based on typical peptide characteristics. Professional laboratory testing (HPLC, mass spectrometry) provides definitive quality verification. This checklist is for initial visual evaluation only.
Cortexin
SynergisticBoth are brain-derived peptide preparations used in Russian neurology for similar indications. May have additive neuroprotective effects.
Semax
CompatibleBoth are neuroprotective peptides used in Russian clinical practice. Semax targets BDNF/NGF pathways similar to cerebrolysin's neurotrophic mechanisms. No known contraindications.
Selank
CompatibleSelank's anxiolytic and immunomodulatory effects complement cerebrolysin's neuroprotective actions. Both used in Russian neurological practice.
BPC-157
CompatibleBPC-157's systemic cytoprotective effects may complement cerebrolysin's CNS-specific neuroprotection. Different target tissues with no known interactions.
Dihexa
CompatibleBoth promote neuroplasticity through different mechanisms - cerebrolysin via neurotrophic factors, Dihexa via HGF/c-Met pathway. Theoretical complementary effects.
Research Note: Interaction data is based on published literature, mechanistic understanding, and theoretical considerations. Most peptide combinations lack direct clinical study. This information is for educational purposes only and does not constitute medical advice. Always consult qualified healthcare providers.
Key Studies Cited
Full reference list available on request. All citations link to PubMed for verification.
This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength ratings follow a modified GRADE approach.
For complete methodology details, see our Methodology page.
Important Disclaimer
This dossier is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.
Get Research Alerts
New dossiers and major study summaries delivered to your inbox. Evidence-graded, citation-backed research you can trust.
No spam. Unsubscribe anytime.
Compare Cerebrolysin
Related Peptides
Alixorexton
ALKS 2680 · ALKS-2680
An oral orexin receptor 2 (OX2R) agonist developed by Alkermes for narcolepsy type 1 (NT1). Phase 2 clinical trials demonstrated improvements in excessive daytime sleepiness and cataplexy with once-daily dosing. Represents a novel approach to restore orexin signaling in patients who have lost orexin-producing neurons.
Cerluten
Brain cytamin · Cerebral peptides · A-5 brain peptides
A cytamin-class peptide supplement derived from brain tissue, part of the Russian bioregulator framework. Marketed as an oral supplement for cognitive support and neuroprotection. Contains peptide complexes rather than defined sequences. No Western clinical validation.
Cortexin
Cortexinum · Polypeptide brain extract · Bovine brain cortex polypeptides
A Russian neuropeptide complex derived from porcine or bovine cerebral cortex, approved in Russia and CIS countries for neurological conditions. Contains low molecular weight polypeptides (1,000-10,000 Da) with proposed neurotrophic and neuroprotective properties. NOT approved by FDA, EMA, or other Western regulatory agencies. Evidence comes primarily from Russian studies with limited Western validation.
Dihexa
PNB-0408 · N-hexanoic-Tyr-Ile-(6) aminohexanoic amide
An angiotensin IV analog developed by Washington State University researchers, claimed to enhance cognition through HGF/c-Met signaling. Gained attention for extreme potency claims (10 million times more potent than BDNF), but evidence is limited to rodent studies from a single research group with no human clinical trials. Sold as a research chemical with unknown safety profile.
DSIP
Delta Sleep Inducing Peptide · Delta Sleep-Inducing Peptide · WAGGDASGE
A nonapeptide discovered in 1977 that was initially thought to induce delta wave sleep. Research has shown broader neuromodulatory effects including stress-protection and analgesia, though its role as an endogenous sleep factor remains controversial.
N-Acetyl Selank Amidate
NA-Selank · N-Acetyl Selank · Acetyl-Selank-Amidate +1
A modified version of Selank with N-terminal acetylation and C-terminal amidation designed to enhance stability and bioavailability. While the parent compound Selank is approved in Russia, N-Acetyl Selank Amidate has no independent clinical research and relies entirely on extrapolated claims from Selank studies.