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Home/Compounds/Cerebrolysin
CognitiveRx required

Cerebrolysin

Also known as: FPF-1070

Peptide preparation derived from porcine brain tissue; approved in ~50 countries for stroke and dementia, not FDA approved.

B
Grade B
Human observational studies
Human studies23
PubMed citations30
Routeintramuscular, intravenous
Regulatory (US)Rx required
Last verified2 days ago

Mechanism of action

Mixture of low-molecular-weight peptides (<10 kDa) produced by standardized enzymatic breakdown of purified brain proteins. Proposed neurotrophic and neuroprotective effects.

Evidence summary

23
Human studies
30
PubMed citations
25
Clinical trials
B
Evidence grade

Multiple RCTs for ischemic stroke, traumatic brain injury, vascular dementia, and Alzheimer disease. Cochrane reviews note methodological concerns.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
intramuscularintravenous

Side effects & safety

No FDA label or editorial side-effect profile is on file for this compound yet. See the clinical trials and citations sections for study-reported safety data.

Interactions

No documented drug interactions on file.

Regulatory status

United States
Not FDA approved

Not FDA approved. Approved in ~50 countries including most of Europe, Russia, and China.

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT06052787The Impact and Outcomes of Combined Cerebrolysin and Amantadine Sulfate Administration on Management of Patients With Traumatic Brain Injury in the ICUCompleted · Phase 3 · Traumatic Brain Injury · n=150NCT05821075Comparative Study Between Prednisolone, Cerebrolysin in the Treatment of Bell's PalsyRecruiting · Phase 1 · Bell Palsy · n=90NCT07043686Effect of Cerebrolysin on Early Rehabilitation After Ischemic Stroke at the Department of Vascular Neurology and Intensive Neurological Therapy (KOVNINT), University Medical Centre LjubljanaRecruiting · N/A · Ischemic Stroke, Acute · n=30NCT06899464Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral HemorrhageNot Yet Recruiting · Phase 4 · Intracerebral Hemorrhage · n=30NCT06897176Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center StudyRecruiting · Phase 4 · Stroke · n=40NCT03480698C-REGS2 - a Registry Study to Observe Clinical Practices, Safety and Efficiency of Routine Use of Cerebrolysin in the Treatment of Patients with Moderate to Severe Neurological Deficits After Acute Ischaemic StrokeCompleted · Acute Ischemic Stroke · n=1851NCT05755997A Randomized, Double-blind, Single-centre, Two-period Cross-over, Placebo-controlled Trial on Safety and Efficacy in Patients With Genetically Proven CADASILActive Not Recruiting · Phase 2 · Cadasil · n=30NCT06677502The Usefulness of Cerebrolysin in Alleviating the Severity of Delirium in Critically Ill PatientsEnrolling By Invitation · N/A · Cognitive Impairment · n=500NCT06208540Persistent Olfactory and Gustatory Dysfunctions Due to Different SARS-CoV-2 Variants: Clinical Characteristics and TreatmentCompleted · Phase 4 · Post-covid-19 Persistent Smell and Taste Disorders · n=160NCT06489925Cerebrolysin as an Add-On Therapy to Standard Treatment of Posterior Circulation Stroke Secondary to Basilar Artery OcclusionNot Yet Recruiting · Phase 1 · Basilar Artery Occlusion · n=20NCT06429943Cerebrolysin in Patients Diagnosed With SAH - an Observational Cohort Study (PILOT)Completed · SAH (Subarachnoid Hemorrhage) · n=47NCT06339411Examining the Efficacy of Cerebrolysin-Augmented Extended Time Window Thrombectomy in Acute Ischemic Stroke: An In-depth Study of Blood-brain Barrier Biomarkers and Imaging IndicatorsNot Yet Recruiting · Phase 1 · Acute Ischemic Stroke · n=100

Showing 12 of 25 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 40087248Cook AM, Michas M et al. · Update on Neuroprotection after Traumatic Brain Injury.CNS drugs (2025)HumanPMID 39957612Homberg V, Jianu DC et al. · Speech Therapy Combined With Cerebrolysin in Enhancing Nonfluent Aphasia Recovery After Acute Ischemic Stroke: ESCAS Randomized Pilot Study.Stroke (2025)HumanPMID 41198594Masserini F, Gendarini C et al. · Therapeutic strategies in vascular cognitive impairment: A systematic review and meta-analysis.Alzheimer's &amp; dementia : the journal of the Alzheimer's Association (2025)HumanPMID 40851188Vosko MR, Sanak D et al. · C-REGS2-A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke.International journal of stroke : official journal of the International Stroke Society (2025)HumanPMID 40325343Staszewski J, D&#x119;biec A et al. · 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.Translational stroke research (2025)HumanPMID 40971139Chan TYH, Ma BY et al. · Microglial Polarization and Therapeutic Strategies in Post-stroke Neuroinflammation.Neurology and therapy (2025)HumanPMID 37892776Kojder K, Jarosz K et al. · Cerebrolysin in Patients with Subarachnoid Hemorrhage: A Systematic Review and Meta-Analysis.Journal of clinical medicine (2024)HumanPMID 38585517Firstenfeld AJ, Listorti J et al. · Add-on treatment with Cerebrolysin improves clinical symptoms in patients with ALS: results from a prospective, single-center, placebo-controlled, randomized, double-blind, phase II study.Journal of medicine and life (2024)HumanPMID 38188053Boksha I, Savushkina O et al. · Late onset psychosis treatment with adjunctive medicines.Frontiers in psychiatry (2024)PMID 38737662Seidl LF, Aigner L · Comparing the biological activity and composition of Cerebrolysin with other peptide preparations.Journal of medicine and life (2024)HumanPMID 39055722Trimmel H, Tauber W et al. · Life-Threatening Anaphylaxis due to Cerebrolysin&#xae;.Case reports in neurological medicine (2024)PMID 36979317Jarosz K, Kojder K et al. · Cerebrolysin in Patients with TBI: Systematic Review and Meta-Analysis.Brain sciences (2023)PMID 37052231Rejdak K, Sienkiewicz-Jarosz H et al. · Modulation of neurotrophic factors in the treatment of dementia, stroke and TBI: Effects of Cerebrolysin.Medicinal research reviews (2023)HumanPMID 37366867Riccardi G, Niccolini GF et al. · Post-COVID-19 Anosmia and Therapies: Stay Tuned for New Drugs to Sniff Out.Diseases (Basel, Switzerland) (2023)PMID 36946392Bogolepova AN · [Cerebrolysin in the treatment of cognitive impairment].Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova (2023)PMID 34924395Fan F, Liu H et al. · The Efficacy and Safety of Alzheimer's Disease Therapies: An Updated Umbrella Review.Journal of Alzheimer's disease : JAD (2022)HumanPMID 34214867Poljakovic Z, Supe S et al. · Efficacy and safety of Cerebrolysin after futile recanalisation therapy in patients with severe stroke.Clinical neurology and neurosurgery (2022)HumanPMID 34494216Fiani B, Chacon D et al. · Neuroprotective strategies of cerebrolysin for the treatment of infants with neonatal hypoxic-ischemic encephalopathy.Acta neurologica Belgica (2022)HumanPMID 35268364Mure&#x219;anu DF, Livin&#x21b; Popa L et al. · Role and Impact of Cerebrolysin for Ischemic Stroke Care.Journal of clinical medicine (2022)PMID 33515100Fiani B, Covarrubias C et al. · Cerebrolysin for stroke, neurodegeneration, and traumatic brain injury: review of the literature and outcomes.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology (2021)Human

Showing 20 of 30 papers. View all on PubMed →