Cerebrolysin

Cerebrolysin is a mixture of peptides derived from porcine brain tissue with neurotrophic factor-like activity. It contains peptides that can cross the blood-brain barrier. Approved in several European and Asian countries for treatment of stroke, traumatic brain injury, and dementia.

PubMed results: 621 · Human studies: 319 · Animal studies: 521

Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.

• Intramuscular — standard range 10-30 mL, Daily for 10-20 days
• Intravenous — standard range 10-50 mL, Daily for 10-20 days

Unknown (low confidence)

• Neurotrophic factor-like activity (Moderate clinical): Cerebrolysin is a porcine brain-derived peptide preparation researched for neurotrophic factor-like effects and ability of constituent peptides to engage central nervous system pathways
• Stroke recovery research outcomes (Moderate clinical): Clinical studies and use in several European and Asian countries have examined Cerebrolysin in acute ischemic stroke settings, with mixed but actively studied effects on functional recovery measures
• Traumatic brain injury research (Moderate clinical): Trials and observational research have investigated Cerebrolysin in traumatic brain injury populations for cognitive and neurological recovery endpoints
• Dementia and Alzheimer disease research (Moderate clinical): Cerebrolysin has been studied for cognitive endpoints in Alzheimer disease and related dementias in regions where it is authorized, with heterogeneous trial results across study designs

• Injection site reactions and local discomfort — Mild, Common. Parenteral administration research commonly notes local reactions at the injection or infusion site
• Headache, dizziness, or agitation — Mild, Uncommon. Clinical literature reports occasional nervous-system related events such as headache, dizziness, or restlessness in treated cohorts
• Hypersensitivity reactions — Serious, Rare. As a biological peptide mixture derived from animal tissue, rare hypersensitivity responses have been described in product and clinical literature

• Hypersensitivity to Cerebrolysin or porcine-derived proteins (Established): Porcine brain-derived composition creates a recognized risk of allergic reactions in sensitized individuals
• Severe renal impairment (per some regional labels) (Clinical): Certain regional prescribing information for authorized markets lists severe kidney impairment among restrictions based on clinical experience with parenteral peptide preparations

Lyophilized (powder): Refrigerated (2-8°C), Up to 24 months. Light sensitive: yes, store dark

Reconstituted (solution): Refrigerated (2-8°C), 4-6 weeks. Solvent: Bacteriostatic water

• NCT01822951 — Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT) (PHASE4), status: WITHDRAWN. Indications: Alzheimer Disease
• NCT05807503 — Evaluation of the Effect of Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury, status: COMPLETED. Indications: TBI (Traumatic Brain Injury)
• NCT05124353 — Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT (PHASE2 / PHASE3), status: UNKNOWN. Indications: Stroke, Acute, Ischemic
• NCT06208540 — Clinical Characteristics and Treatment of Anosmia and Ageusia Due to SARS-CoV2 Variants (PHASE4), status: COMPLETED. Indications: Post-covid-19 Persistent Smell and Taste Disorders
• NCT01556854 — Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke, status: UNKNOWN. Indications: Acute Ischemic Stroke
• NCT01996761 — Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke (PHASE4), status: COMPLETED. Indications: Cerebrolysin
• NCT06052787 — Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU (PHASE3), status: COMPLETED. Indications: Traumatic Brain Injury
• NCT06899464 — Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial (PHASE4), status: NOT_YET_RECRUITING. Indications: Intracerebral Hemorrhage, Hemorrhagic Stroke, Intracerebral, Hemorrhagic Stroke, Stroke
• NCT04124367 — IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE (PHASE2), status: TERMINATED. Indications: Chronic Stroke, Subacute Stroke
• NCT01787123 — Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin™ in Patients With Aneurysmal Subarachnoid Hemorrhage (PHASE2 / PHASE3), status: COMPLETED. Indications: Subarachnoid Hemorrhage, Intracranial Aneurysm, Delayed Cerebral Ischemia, Delayed Ischemic Neurological Deficit
• NCT05821075 — Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy (PHASE1 / PHASE2), status: RECRUITING. Indications: Bell Palsy
• NCT00868283 — The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke (PHASE4), status: COMPLETED. Indications: Ischemic Stroke
• NCT02541227 — Cerebrolysin REGistry Study in Stroke, status: TERMINATED. Indications: Ischemic Stroke
• NCT06677502 — Cerebrolysin in Critically Ill Patients With Delirium (NA), status: ENROLLING_BY_INVITATION. Indications: Cognitive Impairment
• NCT03480698 — Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness, status: COMPLETED. Indications: Acute Ischemic Stroke
• NCT06273020 — Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke (PHASE4), status: UNKNOWN. Indications: Ischemic Stroke, Acute, Diabetes Mellitus, Type 2, Blood Brain Barrier
• NCT02116348 — Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy (PHASE2), status: UNKNOWN. Indications: Cerebral Palsy Children, Children With Traumatic Brain Injury, Mental Handicap, Delayed Speech Development
• NCT04913831 — Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study (PHASE4), status: UNKNOWN. Indications: Stroke
• NCT06429943 — Cerebrolysin in SAH (Subarachnoidal Haemorrhage) - Observational Study, status: COMPLETED. Indications: SAH (Subarachnoid Hemorrhage)
• NCT06078215 — CERebrolysine Effect on Blood-brain Barrier in acUte Ischemic Stroke (PHASE4), status: UNKNOWN. Indications: Acute Ischemic Stroke