One-sentence identity: Cerebrolysin (also Cerebrolysin®, FPF-1070 / FPE 1070, Renacenz) is a porcine-brain-derived proteolytic peptide-and-amino-acid mixture (a hydrolysate), not a single defined peptide sequence.

Identity below is taken only from pages that were opened. No opened registry printed a unique amino-acid sequence, a molecular formula, an InChIKey, or a complete active-peptide inventory. Do not invent a sequence, a CAS for a “main peptide,” or an “active peptide list.”

Related product (vendor listing, not evidence): Simple Research Peptides lists “Cerebrolysin (60 mg Vial)” under Brain & Mind Research, printed as “Cerebrolysin (60 mg / 3 mL Vial)” and “Also Known As: Cerebrolysin Peptide Complex,” with research-use-only language. The opened product page did not print a peptide sequence, CAS number, UNII, molecular formula, or an active-peptide list. Vendor marketing, including the page’s educational reconstitution / “dosage chart” language, is not scientific evidence and is not reproduced here as a use instruction.

What opened registries do not list

• A single peptide sequence, length, or “main active peptide.”
• A defined small-molecule structure, SMILES, InChIKey, or molecular weight for the mixture as a whole.
• A PubChem compound CID (mixture, not a discrete compound).
• Proof that a 60 mg research vial matches the Austrian licensed concentrate (215.2 mg/mL solution).
• An FDA NDA/BLA or a centralized EMA marketing authorization.

FDA UNII disclaimer (printed on the opened UNII page): UNII availability “does not imply any regulatory review or approval.”

A lab cannot treat “Cerebrolysin 60 mg” as interchangeable with a sequence-defined peptide, and cannot assume a research vial is the same article as EVER Pharma Cerebrolysin® ampoules. The manufacturer’s own FAQ (opened) states that biological products cannot be copied 100% and that a similar composition would be a biosimilar requiring its own studies.

Not Semax. Semax is a defined peptide sequence. Cerebrolysin is an enzymatic hydrolysate of porcine brain protein. They are not synonyms, not interchangeable catalog items, and not the same chemical class.

Proposed, not proven Manufacturer / review language is a claim, not a receptor proof. Cochrane reviews describe Cerebrolysin as a mixture of low-molecular-weight peptides and free amino acids derived from porcine brain, with proposed neuroprotective and neurotrophic properties “similar to naturally occurring growth factors such as nerve growth factor and brain-derived neurotrophic factor” (Ziganshina et al., 2023, PMID 37818733; Cui et al., 2019, PMID 31710397). The 2023 Cochrane stroke review also printed a traditional 80% peptide / 20% free-amino-acid split and noted that there is no clear understanding of the molecular mechanism (citing Gulyaeva 2019 in that review; that secondary citation was not opened here).

Opened composition work Gevaert et al. (2015, PMID 26017115, DOI 10.1002/dta.1817) profiled an Internet-obtained Cerebrolysin sample by HPLC–ion-trap and UHPLC–ion-mobility–QTOF MS against the UniProt pig proteome plus de novo sequencing. They identified 638 unique peptides. Main components originated from tubulin alpha- and beta-chain, actin, and myelin basic protein. No fragments of GDNF, NGF, BDNF, or CNTF were found. The authors suggested that reported activities, if real, are more likely from “hitherto unknown cryptic peptides” than from intact neurotrophic-factor fragments.

What this does not show. Gevaert analyzed one internet sample, not an SRP vial and not a documented EVER production batch. Absence of NGF/BDNF fragments in that sample does not prove the licensed drug has none, and presence of tubulin/actin/MBP peptides does not prove a clinical effect. No opened paper established a high-resolution receptor complex for “Cerebrolysin” as a single ligand. Mixture pharmacology is not the same as a defined peptide–receptor pair.

United States. Manufacturer pages state Cerebrolysin is not registered with FDA and not approved for sale or distribution in the United States (cerebrolysin.com FAQs; About). NCATS lists approval year Unknown and “Possibly Marketed Outside US.” FDA UNII 37KZM6S21G exists; the UNII page states that a UNII is not approval. No opened FDA label, NDA, or BLA was found.

European Union. No centralized EMA EPAR for Cerebrolysin was found among opened EMA pages. An opened EMA COMP minutes document (6–8 October 2020) refers to cerebrolysin as a product that “is authorised nationally in the EU” (used there as a comparator in an unrelated orphan-designation discussion). That is national authorization language, not a centralized EU-wide marketing authorization. EMA COMP minutes PDF.

Manufacturer Austrian SPC text (opened About page). Prescription-only solution for injection. Printed indications on that page: cerebrovascular disorders, especially senile dementia of Alzheimer’s type, vascular dementia, stroke, and craniocerebral trauma. Contraindications printed there: hypersensitivity, epilepsy, severe renal impairment. This is Austrian prescribing information for the licensed product, not a US label and not a description of a 60 mg research vial. Printed concentrate: 215.2 mg of Cerebrolysin® concentrate per mL in aqueous solution. Excipients: sodium hydroxide and water for injection. MAH: EVER Neuro Pharma GmbH, Unterach, Austria.

Use geography in Cochrane. The 2023 Cochrane stroke review states Cerebrolysin is widely used for acute ischaemic stroke in Russia, Eastern Europe, China, and other Asian and post-Soviet countries, and notes listing on some national essential-medicine lists (Russia, Slovakia, Romania, Vietnam, Uganda, Syrian Arab Republic) as printed in that review.

National approval abroad is not FDA approval and is not evidence that a research-catalog vial is that licensed medicine.

Opened work falls into four layers. None of it is a substitute for controlled laboratory characterization of a specific vial. Historical clinical regimens below are study conditions only. They are not use instructions. This page does not give human doses.

Headline results that must stay visible: CASTA n=1,070 PRIMARY NEUTRAL; CERE-LYSE-1 STOPPED; CARS exploratory; Cochrane 2023 no death benefit + more non-fatal SAEs. Vascular-dementia Cochrane: very-low-quality. AD Gauthier: 6-month cognition ns. TBI CAPTAIN: terminated, n=46 ITT missed.

The largest confirmatory stroke trial that was opened is CASTA. It did not win its primary endpoint. A later alteplase-combination trial was stopped. Cochrane 2023 judged little to no effect on all-cause death and a potential increase in non-fatal serious adverse events. Smaller motor-recovery studies are exploratory and manufacturer-linked.

Opened dementia evidence is smaller, older, and graded very low quality for vascular dementia. The opened Alzheimer’s meta-analysis lost its cognition signal by 6 months. None of this is a treatment recommendation, and none of it describes a 60 mg research vial.

The opened dedicated RCT is small and terminated. Broader TBI meta-analyses are heterogeneous and cohort-heavy. Cochrane VaD (2019) summarized an earlier TBI review as suggesting possible benefit “weakened by imprecision and methodological flaws.”

Opened papers leave the following unresolved. This list is not a residual “maybe it still works” sales hedge. It is the gap list from the sources that were actually opened.

Claims below appear on the opened SRP product page or manufacturer site, or are common in secondary marketing. The right-hand column is what opened papers and registries actually show. Vendor educational reconstitution / “dosage chart” language is not reproduced as a use instruction.

Treat Cerebrolysin as an undefined mixture. Do not assume a sequence. If a COA is used, read it as batch-specific peptide/amino-acid profile data, not as proof of equivalence to Cerebrolysin®. Orthogonal methods (LC–MS peptide mapping, amino-acid analysis, residual-protein/endotoxin/bioburden as applicable) are the identity tools—not a catalog name.

Opened registries assign UNII 37KZM6S21G and CAS 12656-61-0 to the mixture name. A given vial is only as good as independent identity and purity data. Gevaert 2015 (PMID 26017115) is an analytical case study of one internet sample, not a certificate for an SRP lot.

This page summarizes published laboratory, animal, and investigational or licensed-abroad clinical research on the branded porcine-brain hydrolysate studied as Cerebrolysin® (EVER Neuro Pharma / Ebewe). It does not recommend use in people. Historical clinical regimens are study conditions only.

Answers below are research-use-only facts from opened pages. They are not medical advice and not a use protocol.

Only sources that were opened. Do not add PMIDs, DOIs, or NCT numbers that are not on the Allowed lists.

Allowed PMID list used on this page: 37818733, 31710397, 22282884, 23009193, 26564102, 28707130, 26934986, 20656516, 25832905, 26017115, 31494820, 27539610, 30643411. Allowed NCT list (full pages): NCT00868283, NCT00840671, NCT01606111, NCT01996761, NCT00947531. CAS 12656-61-0. UNII 37KZM6S21G. EudraCT 2007-000870-21 as printed on the opened CARS abstract. No other PMIDs or NCTs were added.

Product links are research materials, not treatment recommendations. The opened SRP page lists Cerebrolysin (60 mg / 3 mL Vial) under Brain & Mind Research as a “Cerebrolysin Peptide Complex.” Footer language on that page is research-use-only. A 60 mg research vial is not claimed identical to EVER Pharma 215.2 mg/mL Cerebrolysin®.