{ "checked": "2026-10-25", "page": "https://jabbitapp.com/research/cerebrolysin-brain-peptide-nootropic-stroke-dementia-evidence-teardown.html", "manufacturer_notice": { "url": "https://www.cerebrolysin.com/cerebrolysin/about-cerebrolysin", "quotes": [ "Please be advised that Cerebrolysin is not registered with the U.S. Food and Drug Administration (FDA) and is not approved for sale or distribution in the United States.", "Cerebrolysin is a prescription medication for use under the supervision of an authorized health care professional." ] }, "label_at": { "url": "https://www.everpharma.com/aut/wp-content/uploads/sites/5/2023/01/Cere-SPC_v_ev1_AT_5.1_clean-1.pdf", "version": "März 2021", "quotes_de": [ "proteolytischen Peptidfraktion aus Schweinehirnprotein", "Status epilepticus.", "Schwere Nierenfunktionsstörungen.", "da hierbei eine Steigerung der Anfallfrequenz auftreten kann", "Einzelne Grand mal Anfälle und ein Fall von Konvulsion", "Eine direkte Messung pharmakokinetischer Parameter kann daher nicht durchgeführt werden.", "EVER Neuro Pharma GmbH, A-4866 Unterach", "Datum der Erteilung der Zulassung: 25.03.1996", "Rp, apothekenpflichtig", "Eine Anwendung bei Kindern und Jugendlichen unter 18 Jahren wird aufgrund unzureichender Datenlage nicht empfohlen", "Zur unterstützenden Behandlung von cerebrovaskulären Störungen", "senile Demenz vom Alzheimertyp und vaskuläre Demenz", "postapoplektische Ausfallserscheinungen", "Schädel-Hirntraumata (Commotio und Contusio)" ] }, "fda": { "warning_letter_2020": { "id": "594743", "date": "2020-04-01", "quotes": [ "are not the subject of an applicable USP or NF monograph, are not a component of an FDA-approved human drug", "Cerebrolysin, DSIP, Epitalon", "have not been nominated for inclusion on the 503A bulks list" ] }, "drugsfda": "no match", "ndc": "no match", "cats503a_2026_05_14": "not listed", "safety_risks_page": "not listed", "faers_reports": 80, "faers_last_updated": "2026-07-30" }, "wada_2026": "not named", "registry": { "clinicaltrials_gov_records": 43, "status_counts": { "ENROLLING_BY_INVITATION": 1, "UNKNOWN": 11, "RECRUITING": 4, "COMPLETED": 19, "NOT_YET_RECRUITING": 3, "TERMINATED": 3, "ACTIVE_NOT_RECRUITING": 1, "WITHDRAWN": 1 }, "lead_sponsor_ever_neuro_pharma": 10, "open_or_planned": 9 }, "pubmed": { "query": "cerebrolysin", "count": 676 }, "key_trials": [ { "trial": "CASTA 2012, acute stroke", "n": 1070, "result": "Main goal: no difference", "pmid": "22282884" }, { "trial": "CEREHETIS 2023, stroke (open-label)", "n": 341, "result": "Fewer bleeds; no 90-day difference", "pmid": "36973684" }, { "trial": "CAPTAIN II 2020, brain injury", "n": 142, "result": "Small-to-medium combined benefit", "pmid": "31897941" }, { "trial": "ESCAS 2025, post-stroke aphasia", "n": 132, "result": "Better language scores", "pmid": "39957612" }, { "trial": "Iran 2017, early stroke recovery", "n": 100, "result": "Better day-30 stroke scores", "pmid": "29075343" }, { "trial": "Korea 2000, Alzheimer's disease", "n": 53, "result": "Better at 4 weeks; daily life same", "pmid": "11129744" }, { "trial": "Healthy men 1998, EEG study", "n": 48, "result": "EEG changes; memory only a trend", "pmid": "9700674" }, { "trial": "CAPTAIN I 2020, brain injury", "n": 46, "result": "Main goal just missed", "pmid": "31494820" } ], "key_trials_total_n": 1932, "abstract_quotes": { "37818733": { "title": "Cerebrolysin for acute ischaemic stroke", "journal": "Cochrane Database Syst Rev", "year": "2023", "quotes": [ "mixture of low-molecular-weight peptides and amino acids derived from porcine brain", "widely used in the treatment of acute ischaemic stroke in Russia, Eastern Europe, China, and other Asian and post-Soviet countries", "Seven RCTs (1773 participants)", "The manufacturer of Cerebrolysin supported three multicentre studies", "(risk ratio (RR) 0.96, 95% confidence interval (CI) 0.65 to 1.41; 6 trials, 1689 participants; moderate-certainty evidence)", "None of the included studies reported on poor functional outcome", "(RR 2.39, 95% CI 1.10 to 5.23; 3 trials, 1335 participants; moderate-certainty evidence)", "probably have no beneficial effect on preventing all-cause death in acute ischaemic stroke", "Moderate-certainty evidence also indicates a potential increase in non-fatal serious adverse events with Cerebrolysin use." ] }, "22282884": { "title": "Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial", "journal": "Stroke", "year": "2012", "quotes": [ "A total of 1070 patients were enrolled", "The confirmatory end point showed no significant difference between the treatment groups.", "This observation should be confirmed by a further clinical trial." ] }, "26564102": { "title": "Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial", "journal": "Stroke", "year": "2016", "quotes": [ "indicated a large superiority of Cerebrolysin compared with the placebo (Mann-Whitney estimator, 0.71", "Because this study was exploratory and had a relatively small sample size, the results should be confirmed in a large-scale, randomized clinical trial." ] }, "29075343": { "title": "Efficacy and safety of Cerebrolysin treatment in early recovery after acute ischemic stroke: a randomized, placebo-controlled, double-blinded, multicenter clinical trial", "journal": "J Med Life", "year": "2017", "quotes": [ "enrolled a total of 100 patients", "indicated a medium to large superiority of cerebrolysin compared to placebo" ] }, "28458521": { "title": "Cerebrolysin for functional recovery in patients with acute ischemic stroke: a meta-analysis of randomized controlled trials", "journal": "Drug Des Devel Ther", "year": "2017", "quotes": [ "A total of 1,649 patients", "Cerebrolysin had no significant effect on functional recovery at Day 90", "routine administration of cerebrolysin to patients with AIS cannot be supported by the available evidence from RCTs." ] }, "29248999": { "title": "Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials", "journal": "Neurol Sci", "year": "2018", "quotes": [ "N = 1879", "Safety aspects were comparable to placebo." ] }, "34152062": { "title": "European Academy of Neurology and European Federation of Neurorehabilitation Societies guideline on pharmacological support in early motor rehabilitation after acute ischaemic stroke", "journal": "Eur J Neurol", "year": "2021", "quotes": [ "are recommended for clinical use for early neurorehabilitation after acute ischaemic stroke" ] }, "41018475": { "title": "Safety and Efficacy of Cerebrolysin for Neurorecovery After Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of 14 Randomized Controlled Trials", "journal": "Cureus", "year": "2025", "quotes": [ "Fourteen randomized controlled trials (N = 2,884 patients)", "Further high-quality trials are warranted" ] }, "39957612": { "title": "Speech Therapy Combined With Cerebrolysin in Enhancing Nonfluent Aphasia Recovery After Acute Ischemic Stroke: ESCAS Randomized Pilot Study", "journal": "Stroke", "year": "2025", "quotes": [ "14.805 (95% CI, 9.521-20.089) points (P<0.001)", "Further research with larger cohorts is needed" ] }, "36973684": { "title": "Cerebrolysin as an Early Add-on to Reperfusion Therapy: Risk of Hemorrhagic Transformation after Ischemic Stroke (CEREHETIS), a prospective, randomized, multicenter pilot study", "journal": "BMC Neurol", "year": "2023", "quotes": [ "no difference in the mRS score was observed on day 90" ] }, "31494820": { "title": "Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial", "journal": "Neurol Sci", "year": "2020", "quotes": [ "In 46 enrolled TBI patients (Cerebrolysin 22, placebo 24)", "statistical significance was just missed in the intention-to-treat population" ] }, "31897941": { "title": "Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial", "journal": "Neurol Sci", "year": "2020", "quotes": [ "The study enrolled 142 patients", "indicated a \"small-to-medium\"-sized effect in favor of Cerebrolysin" ] }, "33620612": { "title": "Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series", "journal": "Neurol Sci", "year": "2021", "quotes": [ "A total 185 patients" ] }, "36979317": { "title": "Cerebrolysin in Patients with TBI: Systematic Review and Meta-Analysis", "journal": "Brain Sci", "year": "2023", "quotes": [ "Mortality of any cause and the length of stay was not affected by the treatment." ] }, "31710397": { "title": "Cerebrolysin for vascular dementia", "journal": "Cochrane Database Syst Rev", "year": "2019", "quotes": [ "all studies were supported by the pharmaceutical industry", "very low-quality evidence", "However, these data are not definitive." ] }, "23440834": { "title": "Cerebrolysin for vascular dementia", "journal": "Cochrane Database Syst Rev", "year": "2013", "quotes": [ "there is still insufficient evidence to recommend Cerebrolysin as a routine treatment for vascular dementia" ] }, "25832905": { "title": "Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials", "journal": "Dement Geriatr Cogn Disord", "year": "2015", "quotes": [ "There were 6 eligible randomized controlled trials comparing Cerebrolysin with placebo." ] }, "11129744": { "title": "A double-blind, placebo-controlled, multicenter study of Cerebrolysin for Alzheimer's disease", "journal": "J Am Geriatr Soc", "year": "2000", "quotes": [ "Fifty-three men and women at least 50 years of age", "over 4 weeks in patients with probable Alzheimer's disease (AD)" ] }, "9700674": { "title": "Dose-dependent effects of Cerebrolysin on EEG and short-term memory of healthy volunteers during control and hyperventilation induced cerebral ischemia", "journal": "J Neural Transm Suppl", "year": "1998", "quotes": [ "Cerebrolysin, a peptidergic nootropic drug", "48 healthy males were enrolled", "there is a trend towards less effective word recall for the baseline situation during the first 4 hours for the placebo" ] }, "41880098": { "title": "Efficacy and Safety of Cerebrolysin as an Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Observational Studies", "journal": "Brain Behav", "year": "2026", "quotes": [ "three observational studies involving a total of 294 patients" ] }, "34959697": { "title": "Safety of Cerebrolysin for Neurorecovery after Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Twelve Randomized-Controlled Trials", "journal": "Pharmaceuticals (Basel)", "year": "2021", "quotes": [ "The meta-analysis pooled 2202 patients from twelve randomized clinical trials, registering non-statistically significant (p > 0.05) differences between Cerebrolysin and placebo" ] } }, "analysis": { "note": "Jabbit analysis. Cerebrolysin is a licensed injectable pig-brain peptide mixture in parts of Europe and Asia, not approved in the US. The largest stroke trial was neutral, the Cochrane review found no effect on death and a possible rise in non-fatal serious adverse events, and positive results come mostly from smaller, often manufacturer-linked trials. There is no trial of cognitive enhancement in healthy people." } }