{"slug":"cerebrolysin","seoKey":"cerebrolysin","displayName":"Cerebrolysin","codes":["FPF-1070","FPF 1070","FPE 1070"],"synonyms":["proteolytic peptide fraction from porcine brain protein","porcine brain-derived peptide preparation","swine brain hydrolysate","Cerebrolyzin","Cerebrolysine","Церебролизин"],"legalClass":"rx","identifiers":{"cas":"12656-61-0","unii":"37KZM6S21G","wikidataQid":"Q19946892"},"approvals":[{"market":"US","status":"not_approved","note":"Not approved. A fourfold negative finding with working controls on 2026-09-15: no record in the agency's approved drug database, none in the national drug code directory, no label, and no entry in the label repository. The manufacturer states on its own product page that the preparation is not registered with the agency and not approved for sale or distribution there. An orphan designation for frontotemporal dementia was granted on 2016-04-05 under number 513315, which is a development incentive and not an approval; the register itself records the substance as not approved for the orphan indication. Compounded material has drawn enforcement: two warning letters and two class II recalls. The substance is on no list of bulk substances permitted in compounding, and the agency notes it was never even nominated for one.","source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=513315"},{"market":"EU","status":"approved_rx","date":"1996-03-25","note":"Prescription-only through the NATIONAL route, not the centralised one. Austria granted authorisation 1-21380 on 1996-03-25 and renewed it on 2001-03-25; section 11 of the product information reads \"prescription-only, pharmacy-only\". There is no centralised European authorisation: the Commission register of centrally authorised human medicines, downloaded in full on 2026-09-15, returned 0 matches, with a working control query returning 2. The regulator's own full-text search answered with HTTP 401 and could not be used. The Austrian authorisation makes this a lawfully marketed prescription medicine inside the Union, so the advertising ban of Article 88(1) of Directive 2001/83/EC applies.","source":"https://medikamente.basg.gv.at/documents/1-21380__DOTC_FACH_INFO.pdf"},{"market":"DE","status":"not_approved","note":"No national authorisation could be established, and the substance is not named in the prescription-only annex either. That is not a licence to trade: the annex lists substances that are prescription-only even without an authorisation, whereas here the prescription status follows from the authorised Austrian medicine itself. Without a German authorisation, placing it on the market breaches section 21 of the medicines act; supply is conceivable only as a named-patient import against a prescription under section 73(3). CAVEAT: the national medicines information system was unreachable on 2026-09-15 (HTTP 500 and HTTP 404), so this is not a register-verified negative finding. A production site of the manufacturer group exists in Jena; a production site is not an authorisation. The annex to the anti-doping act contains no match, verified against working controls.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"not_approved","note":"No authorisation identified. CAVEAT: this is not a primary-verified negative finding. Both the regulator's product index and the medicines compendium deliver their result lists by JavaScript only; on 2026-09-15 just the empty scaffold page was retrievable and the API paths answered with HTTP 404, so no control query was possible either. The finding rests on a 2026 peer-reviewed analysis of nootropic registrations, which checked the British register and found only four of eleven substances used in Russia registered there, none of them this one. Supply would be conceivable only as an unlicensed medicine against a prescription.","source":"https://products.mhra.gov.uk/search/?search=cerebrolysin"},{"market":"AU","status":"not_approved","note":"Not scheduled and no registration identified. The Poisons Standard of June 2026 was downloaded in full (848 558 characters) and searched on 2026-09-15: 0 matches, with working controls in the same text. CAVEAT: the register of therapeutic goods was unreachable from the working environment, so the absence of a registration is not primary-verified. This is no reassurance — importing and advertising unregistered therapeutic goods remains prohibited, and an injectable medicine falls in practice under prescription control.","source":"https://www.legislation.gov.au/F2026L00633/asmade"},{"market":"CA","status":"not_approved","note":"Not approved; no entry in the national drug product database. Negative finding with a working control on 2026-09-15: the active-ingredient interface returned an empty list for this substance and two records for a comparable one, so the interface answers correctly.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=cerebrolysin"},{"market":"CH","status":"not_approved","note":"Not approved. The published extended list of authorised human medicines was downloaded on 2026-09-15 and its full text searched: 0 matches for the substance, for the source material and for the manufacturer, with working controls in the same file returning 147 and 18 matches. Distribution and supply of an unauthorised medicine are not permitted; individual cases fall under import by healthcare professionals.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/listen_neu.html"}],"devStage":"approved","strongestEvidence":"meta_analysis","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT00868283","name":"CASTA — largest placebo-controlled acute stroke trial; confirmatory endpoint not met","phase":"Phase 4","n":1071,"status":"COMPLETED"},{"nct":"NCT03480698","name":"C-REGS2 — observational comparative effectiveness in stroke; no full-text publication found","n":1851,"status":"COMPLETED"},{"nct":"NCT02541227","name":"CREGS-S — registry study in stroke, terminated because the matching target could not be reached","n":1823,"status":"TERMINATED"},{"nct":"NCT04830943","name":"Persistent loss of smell and taste after COVID-19 (randomised but open, without placebo)","phase":"Phase 3","n":250,"status":"COMPLETED"},{"nct":"NCT00947531","name":"Registration-relevant trial in vascular dementia","phase":"Phase 4","n":242,"status":"COMPLETED"},{"nct":"NCT00911807","name":"Neurotrophic versus cholinergic treatment in Alzheimer's disease (three arms, no placebo arm)","phase":"Phase 2","n":217,"status":"COMPLETED"},{"nct":"NCT00840671","name":"CERE-LYSE-1 — combined with thrombolysis in acute hemispheric stroke","phase":"Phase 3","n":119,"status":"COMPLETED"},{"nct":"NCT06339411","name":"After reperfusion in extended-window thrombectomy","phase":"Phase 2","n":100,"status":"NOT_YET_RECRUITING"},{"nct":"NCT02116348","name":"Traumatic brain injury in children","phase":"Phase 2","n":100,"status":"UNKNOWN"},{"nct":"NCT03506841","name":"Neurodevelopment in preterm infants","phase":"Phase 1","n":60,"status":"COMPLETED"},{"nct":"NCT01606111","name":"CAPTAIN I — traumatic brain injury, terminated for poor patient recruitment","phase":"Phase 4","n":46,"status":"TERMINATED"},{"nct":"NCT01059461","name":"Infants with a history of neonatal hypoxic-ischaemic encephalopathy","phase":"Phase 2","n":40,"status":"COMPLETED"},{"nct":"NCT05755997","name":"CADASIL","phase":"Phase 2","n":30,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT04124367","name":"IMPULSE — upper limb recovery after stroke, terminated after four participants","phase":"Phase 2","n":4,"status":"TERMINATED"},{"nct":"NCT01822951","name":"Head-to-head against a cholinesterase inhibitor in dementia, withdrawn before enrolment","phase":"Phase 4","n":0,"status":"WITHDRAWN"}],"sameAs":["https://www.wikidata.org/wiki/Q19946892"],"lastVerified":"2026-09-15","version":"1.0","published":true,"locale":"en","title":"Cerebrolysin: what the trials show, status and safety","summary":"Cerebrolysin is not a single peptide. It is a mixture of amino acids and short peptides made from pig brain protein, so it has no sequence, no formula and no molecular mass. It has been a prescription-only medicine in Austria since 1996 and in South Korea since 2006, and it is licensed across the post-Soviet states. The United States, Canada and Switzerland have never approved it. Cochrane found no effect on deaths after acute stroke, and more non-fatal serious adverse events. Its largest placebo-controlled trial missed its main endpoint.","updated":"2026-09-15","url":"https://mypep.app/peptides/cerebrolysin"}