Cerebrolysin: research

An injectable pig brain mixture with mixed stroke, brain-injury and dementia evidence.

Also called: FPF-1070, Cerebrolysin concentrate.

Nootropic peptides · Porcine brain-derived peptide and amino-acid mixture · Evidence: Approved drug.

National approvals exist, but no FDA approval. Stroke survival benefit is unproven; brain-injury trials are small, and at least 43 human studies were identified.

Studies

• CASTA: acute stroke. rct, n=1070, Ischemic stroke within 12 hours. The largest acute-stroke trial missed its primary endpoint. (source)
• CERE-LYSE-1: with alteplase. rct, n=119, Ischemic stroke receiving alteplase within 3 hours. Early neurological gains did not become a day-90 disability benefit. (source)
• Stroke: 50 mL for 21 days. rct, n=146, Acute stroke within 24 hours. Main neurological and daily-function outcomes were neutral. (source)
• Stroke dose finding: 10 or 50 mL. rct, n=36, Carotid-territory stroke within 12 hours. A tiny dose-finding study reported MRI changes. (source)
• CARS-1: rehabilitation. rct, n=208, Stroke rehabilitation starting 24–72 hours after onset. Arm recovery favored Cerebrolysin in this exploratory trial. (source)
• CARS-2: replication. rct, n=240, Stroke rehabilitation starting 24–72 hours after onset. The replication contributes to pooled evidence but has limited standalone reporting. (source)
• CARS pooled analysis. meta-analysis, n=448, Two rehabilitation RCTs; 448 randomized, 442 analyzed. Pooled arm recovery favored Cerebrolysin, with a smaller effect than CARS-1. (source)
• Subacute stroke: 30 mL. rct, n=70, Motor impairment; treatment on stroke days 8–28. The overall motor endpoint was neutral; a severe subgroup showed benefit. (source)
• Stroke: 30 mL then 10 mL. rct, n=100, Ischemic stroke within 18 hours. A small trial reported less neurological deficit after a stepped-down course. (source)
• Early physical rehabilitation. rct, n=60, Stroke within 24–48 hours. Neurological scores favored drug plus rehabilitation. (source)
• Extended stroke rehabilitation. rct, n=60, Severe arm impairment around 10 days after stroke. Arm function improved more with drug plus extended rehabilitation. (source)
• CEREHETIS: with alteplase. rct, n=341, Stroke receiving alteplase within 4.5 hours. Bleeding was less frequent, but day-90 disability did not differ. (source)
• ESCAS: speech recovery. rct, n=132, Nonfluent aphasia 3–5 days after stroke. Language recovery favored the combination in a pilot study. (source)
• C-REGS2: routine stroke care. cohort, n=1865, Moderate stroke, NIHSS 8–15; 16 countries. Better recovery was associated with use; treatment selection may explain part of it. (source)
• After thrombectomy: two courses. cohort, n=100, Selected anterior-circulation stroke with good reperfusion. Selected patients did better than historical controls; causation is uncertain. (source)
• Thrombectomy: one-year follow-up. cohort, Extension of the 2025 matched cohort. Longer follow-up remained favorable but observational. (source)
• CAPTAIN I. rct, n=46, Moderate to severe traumatic brain injury. CAPTAIN I missed its primary ITT endpoint. (source)
• CAPTAIN II. rct, n=142, Moderate to severe traumatic brain injury. CAPTAIN II found a small combined functional and cognitive benefit. (source)
• CAPTAIN pooled analysis. meta-analysis, n=185, Two moderate-to-severe TBI trials. Pooled findings favor Cerebrolysin but rest on two small trials. (source)
• Mild TBI: five days. rct, n=32, Alert adults with contusion within 24 hours. A small pilot found greater improvement on one cognitive scale. (source)
• Persistent severe TBI disability. cohort, n=129, Severe disability one month after TBI; age >16. Recovery associations came with a seizure safety signal. (source)
• Moderate TBI: 2026 cohort. cohort, n=340, Moderate TBI with nonoperative hemorrhage. Favorable cohort results need randomized confirmation. (source)
• Alzheimer dose finding: 10, 30 or 60 mL. rct, n=279, Mild to moderate Alzheimer disease. 60 mL is the highest verified repeated IV dose; it was not the best cognitive dose. (source)
• Alzheimer trial: 1994. rct, n=120, Mild to moderate Alzheimer disease. Published Alzheimer trial; some outcomes favored drug, with limited long-term evidence. (source)
• Alzheimer trial: Korea. rct, n=53, Mild to moderate Alzheimer disease. Published Alzheimer trial; some outcomes favored drug, with limited long-term evidence. (source)
• Alzheimer: repeated courses. rct, n=149, Mild to moderate Alzheimer disease. Published Alzheimer trial; some outcomes favored drug, with limited long-term evidence. (source)
• Alzheimer: 24-week follow-up. rct, n=192, Mild to moderate Alzheimer disease. Published Alzheimer trial; some outcomes favored drug, with limited long-term evidence. (source)
• Alzheimer: six-week course. cohort, Mild to moderate Alzheimer disease. Published Alzheimer trial; some outcomes favored drug, with limited long-term evidence. (source)
• Alzheimer: with donepezil. rct, n=197, Published efficacy population with Alzheimer disease. Combination did not significantly improve the cognitive endpoint. (source)
• Mild cognitive impairment: annual courses. open-label, n=100, Older adults with amnestic mild cognitive impairment. Reported less progression; dementia prevention remains unconfirmed. (source)
• Alzheimer: IGF-I analysis. cohort, n=207, Completers from the dose-finding trial. Biomarker changes raise questions about use in active cancer. (source)
• Vascular dementia: 242 patients. rct, n=242, Mild to moderate vascular dementia. Cognitive and global scores favored Cerebrolysin. (source)
• Vascular dementia: dose pilot. cohort, n=41, Mild to moderately severe vascular dementia. The pilot does not establish an optimal dose. (source)
• Healthy volunteers: dose experiment. rct, n=48, Healthy men undergoing a hyperventilation challenge. This experiment does not establish a healthy-adult enhancement regimen. (source)
• Brain hemorrhage: 50 mL. rct, n=100, Hemorrhagic stroke. No significant functional benefit was shown. (source)
• Aneurysmal bleeding: pilot. rct, n=50, Aneurysmal subarachnoid hemorrhage. Six-month global recovery did not improve significantly. (source)
• ALS: with riluzole. rct, n=20, Definite ALS receiving riluzole. A very small trial reported functional improvement; replication is needed. (source)
• Schizophrenia: with risperidone. rct, n=109, Schizophrenia dominated by negative symptoms. It did not improve the main psychosis symptoms beyond risperidone. (source)
• Cervical myelopathy: conservative care. rct, n=192, Cervical spondylotic myelopathy. A trial reported improvement; full injection details need confirmation. (source)
• After spine surgery: 21 days. rct, n=60, Operated degenerative cervical myelopathy. Main scores were neutral despite a hand-function signal. (source)
• After spine surgery: 10 days. rct, n=90, Operated degenerative cervical myelopathy. A later small trial reported better one-year neurological scores. (source)
• Persistent smell loss after COVID. rct, n=250, Persistent smell and taste symptoms. A trial at high risk of bias reported recovery with an IM course. (source)
• Post-stroke spasticity: IM cohort. cohort, n=50, Outpatients about 4±3 months after stroke. This cohort documents 10 mL/day IM exposure with weak efficacy evidence. (source)
• Heart surgery: delirium pilot. cohort, n=55, Elective bypass surgery. Delirium findings were inconclusive. (source)
• Life-threatening allergy. case-report, n=1, 85-year-old man with subacute stroke. Severe allergy can occur even with clinical administration. (source)
• Cochrane: acute stroke. systematic-review, n=1773, Six Cerebrolysin trials plus one Cortexin trial. No survival benefit; nonfatal serious harms may rise. (source)
• Stroke safety: 12 trials. meta-analysis, n=2202, Twelve stroke RCTs. Reported benefits remain uncertain because of study design or reporting limitations. (source)
• Stroke recovery: nine trials. meta-analysis, n=1879, Early recovery in nine RCTs. Reported benefits remain uncertain because of study design or reporting limitations. (source)
• Stroke review: 14 trials. meta-analysis, n=2884, Fourteen reported RCTs. Reported benefits remain uncertain because of study design or reporting limitations. (source)
• Alzheimer review: six trials. meta-analysis, Six placebo-controlled 30 mL/day trials. Reported benefits remain uncertain because of study design or reporting limitations. (source)
• Cochrane: vascular dementia. systematic-review, n=597, Six vascular-dementia trials. Reported benefits remain uncertain because of study design or reporting limitations. (source)
• TBI review: ten studies. systematic-review, n=8749, Mixed TBI severity and designs. Reported benefits remain uncertain because of study design or reporting limitations. (source)
• Thrombectomy review: conflicting counts. meta-analysis, Three observational studies. Reported benefits remain uncertain because of study design or reporting limitations. (source)
• Chemical analysis of an online sample. in-vitro, An Internet-obtained sample; no human participants. It is a complex mixture, not a measured dose of named growth factors. (source)
• Comparing peptide mixtures. in-vitro, Laboratory comparison; no human participants. Other brain-protein mixtures cannot be assumed interchangeable. (source)
• Alzheimer: posted results. rct, n=217, Same trial as the 2011 donepezil paper. Registry results add numerical outcomes and adverse-event counts. (source)
• Vascular dementia: posted results. rct, n=242, Same 242-person vascular-dementia trial. Registry results add numerical outcomes and adverse-event counts. (source)
• Stroke comparison: posted results. rct, n=84, 84 randomized; 60 completed. Registry results add numerical outcomes and adverse-event counts. (source)
• CAPTAIN-rTMS: three-arm trial. rct, n=93, Adults with TBI; treatment beginning about one month after injury. The combined intervention did not significantly improve the primary cognitive outcome. (source)
• Stroke: comparison with NBP. rct, n=60, Acute ischemic stroke within 12 hours; published completer cohort. Small-trial findings favored both active agents; attrition limits confidence. (source)

Gaps: No FDA or centralized EMA label found. National schedules are described separately and do not count as FDA/EMA label protocols. HumanStudies is a lower bound of distinct primary datasets mapped here, not PubMed hits or a complete worldwide census. PubMed returned 675 records, 348 human-indexed records and 91 trial-indexed reports, including duplicates, secondary analyses and other agents. The 43 ClinicalTrials.gov matches include planned and related studies. Three had posted results; the registry inventory is in notes.md. Several older, non-English reports and safety tables were accessible only as abstracts. Missing doses, group values and rates were not invented. CARS-2 lacks an independently verified standalone primary report; its dosing and counts come from the pooled publication. CASTA, C-REGS2, the donepezil trial and the NBP comparison have publication-versus-registry count differences. Denominators remain separate. Cochrane and favorable rehabilitation reviews use different trial sets and endpoints. Short-term score gains do not establish survival benefit. The 2025 14-trial and 2026 thrombectomy reviews contain conflicting counts or interpretations; uncertain numerical findings were omitted. CAPTAIN trials are small and use complex combined outcomes. Durable daily-function benefit and rare harms need independent replication. No convincing long-term healthy-adult enhancement, addiction-recovery or dementia-prevention regimen was established. Human intranasal or subcutaneous dose-finding and bioavailability were not verified. Neither route has an established studied dose ceiling. Community frequency labels describe recurrence in this search, not population rates; proposals and completed use are distinguished. A single-site 10 mL muscle injection conflicts with Austrian instructions, even though one cohort used 10 mL/day IM. Milligram-labeled powders cannot inherit the licensed mixture’s trial evidence or a volume-to-dose conversion. The active-cancer block is a precaution based on reported IGF-I changes, not an established cancer signal or label contraindication. Pregnancy, nursing and preconception safety remain unresolved. Pediatric reports do not establish adult-app eligibility. No validated home laboratory schedule, transferred-spray shelf life or community-powder stability was established. No Cerebrolysin-specific PCAC decision or current nomination docket verified. Do not infer compounding eligibility from seller claims. UK negative-search confidence is limited. Australian authorization and broader scheduling coverage remain unresolved. Cerebrolysin is not named in WADA 2026. National approval argues against automatic S0 classification; S2 scope needs an authoritative ruling. No verified controlled human combinations with Semax, Selank, growth hormone, BPC-157 or TB-500 were found. Analytical comparisons do not establish that an online vial is authentic, equivalent, sterile or safe. One actual 20 mL/day IM report exceeds the highest verified 10 mL/day IM human exposure. Broader unpublished exposure cannot be excluded. CAPTAIN I registry and publication differ on repeat-course volume. Published doses are retained; exact repeat dates remain unverified. The step-down stroke trial uses five weekly post-acute doses in its full methods; the abstract oversimplifies this as daily through day 30.

Related to Cerebrolysin

• Semax: A Russian nasal peptide with limited human evidence for brain and nerve effects.
• Selank: A Russian nasal anxiety peptide with uncertain long-term benefit and safety.
• PE-22-28: An experimental mood peptide studied in mice, with no human trials found.
• Dihexa: An experimental memory compound with disputed animal research and no established human dose.
• P21: An experimental memory peptide with animal research and no established human dose or safety profile.
• BPC-157: An experimental repair peptide with mostly animal evidence and a few small human reports.

Cerebrolysin: the short version

Sources

• 21 CFR 216.23 — Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act., Office of the Federal Register · eCFR · 2026
• 503B Bulk Drug Substances List, FDA · FDA · 2026
• Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2026
• Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
• MHRA Products | Home, MHRA · MHRA · 2026
• TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response, Therapeutic Goods Administration · TGA · 2026
• The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
• Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
• Using intramuscular injections in people on oral anticoagulants, NHS Specialist Pharmacy Service · NHS Specialist Pharmacy Service · 2023
• European Academy of Neurology and European Federation of Neurorehabilitation Societies guideline on pharmacological support in early motor rehabilitation after acute ischaemic stroke., Beghi E et al. · European journal of neurology · 2021
• Tailor Made Compounding LLC - 594743 - 04/01/2020, FDA · FDA · 2020
• Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, FDA · FDA · 2000
• CEREBROLYSIN, BASG
• Drug Product Database online query, Health Canada
• PHARMACY & POISONS BOARD OF HONG KONG | 香港藥劑業及毒藥管理局, Hong Kong Department of Health

Sources checked: 2026-10-18.

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