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%
- Human research
- 69%
Based on 32 cited sources
Numeric assessment unreviewed
A historical numeric score is recorded but has not passed a current, compound-specific assessment review. No numeric score is displayed.
This is a limitation of the numeric assessment, not a measured absence of benefit. It does not re-review the separately recorded catalogue classification or establish efficacy or safety.
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 (date type unverified) |
| NCT07043686 | Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study Ischemic Stroke, Acute, Rehabilitation Outcome +1 more | Cerebrolysin | Phase N/A | Recruiting | Jul 2027 (date type unverified) |
| 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 (date type unverified) |
| 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 (date type unverified) |
| 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 (date type unverified) |
| NCT06677502 | Cerebrolysin in Critically Ill Patients With Delirium Cognitive Impairment | Cerebrolysin | Phase N/A | Recruiting | Jun 2025 (date type unverified) |
| NCT05755997 | CERebrolysin In CADASIL Cadasil | Cerebrolysin | Phase 2 | Active | Mar 2026 (date type unverified) |
| 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 (date type unverified) |
| 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 (date type unverified) |
| NCT05821075 | Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy Bell Palsy | Cerebrolysin | Phase 1/2 | Recruiting | Jan 2026 (date type unverified) |
| NCT04427241 | Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness Disorder of Consciousness, Hemorrhagic Stroke | Cerebrolysin | Phase 4 | Recruiting | Sep 2026 (date type unverified) |
| NCT05864677 | Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery Neurocognitive Disorders, Surgery-Complications +3 more | Cerebrolysin | Phase N/A | Unknown | Jun 2024 (date type unverified) |
| NCT06078215 | CERebrolysine Effect on Blood-brain Barrier in acUte Ischemic Stroke Acute Ischemic Stroke | Cerebrolysin | Phase 4 | Unknown | Jan 2025 (date type unverified) |
| 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 (date type unverified) |
| 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 (date type unverified) |
| NCT04124367 | IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE Chronic Stroke, Subacute Stroke | Cerebrolysin | Phase 2 | Terminated | Mar 2022 (date type unverified) |
| 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 (date type unverified) |
| 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 (date type unverified) |
| 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 (date type unverified) |
| NCT04830943 | Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia Covid19 Related Anosmia and Aguesia | Cerebrolysin | Phase 3 | Completed | Sep 2021 (date type unverified) |
| NCT04751136 | the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome Down Syndrome | Cerebrolysin | Phase 2 | Completed | Feb 2019 (date type unverified) |
| NCT03506841 | Cerebrolysin and Neurodevelopment in Preterm Infants Infant Development, Cerebral Palsy +1 more | Cerebrolysin | Phase 1 | Completed | Jun 2019 (date type unverified) |
| NCT02768571 | Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke Stroke | Cerebrolysin | Phase 4 | Completed | Feb 2019 (date type unverified) |
| NCT02581371 | Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm Ischemic Stroke | Cerebrolysin | Phase 4 | Unknown | Feb 2017 (date type unverified) |
| NCT05288465 | Hair Repigmentation During Cerebrolysin Therapy Hair Problems | Cerebrolysin | Phase N/A | Completed | Dec 2015 (date type unverified) |
| 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 (date type unverified) |
| 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 (date type unverified) |
| NCT01606111 | The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery Traumatic Brain Injury | Cerebrolysin | Phase 4 | Terminated | Jul 2015 (date type unverified) |
| NCT01059461 | Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy Hypoxic-Ischemic Encephalopathy | Cerebrolysin | Phase 2 | Completed | Sep 2013 (date type unverified) |
| NCT01996761 | Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke Cerebrolysin | Cerebrolysin | Phase 4 | Completed | Jan 2014 (date type unverified) |
| NCT01388738 | Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke. Stroke | Cerebrolysin | Phase 3 | Completed | Oct 2011 (date type unverified) |
| 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 (date type unverified) |
| 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 (date type unverified) |
| NCT00840671 | Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke Stroke | Cerebrolysin | Phase 3 | Completed | Mar 2008 (date type unverified) |
| 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 (date type unverified) |
| 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 (date type unverified) |
Cerebrolysin and Recovery After Stroke (CARS)
Cerebrolysin and Recovery After Stroke 2 (CARS2)
Cerebrolysin Acute Stroke Treatment in Asia (CASTA)
Cerebrolysin in Moderate Alzheimer's Disease
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
CERebrolysin In CADASIL
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.
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
Use the source links in the research discussion above to inspect the referenced records.
This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength labels summarize the cited material for this entry and should be read alongside its population, model, and study limitations.
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.
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Compared With
4 comparisonsConditions Studied
4 entries- Cerebrolysin for Stroke Cerebrolysin is approved in 50+ countries for stroke treatment. The CARS trial demonstrated significant upper-limb motor recovery…
- Cerebrolysin for Alzheimer's Disease Multiple Phase 3 trials and meta-analyses support cerebrolysin for mild-moderate Alzheimer's disease. A meta-analysis of 6 RCTs sh…
- Cerebrolysin for Vascular Dementia Cerebrolysin has shown benefit in vascular dementia trials. A study of 242 patients demonstrated significant improvement in both A…
- Cerebrolysin for Traumatic Brain Injury Cerebrolysin is used for traumatic brain injury in multiple countries. Preclinical stroke models show enhanced neurogenesis, oligo…