Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.
FDA status
Not approved
Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.
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Evidence tier
Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 3/5. 1,250 PubMed citations indexed.
Standardized peptide mixture derived from porcine brain protein hydrolysis; contains neurotrophic factors including BDNF/NGF-like fractions that promote neuroplasticity and neuroprotection.
What the literature studies
Neuroprotection & Cognitive Recovery
Evidence tier
Human RCT
Compounding record
Status not verified
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source not verified; no checked date is assigned.
animal-derived source raises potential prion concern requiring rigorous testing.
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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.
Cerebrolysin is a porcine-brain-derived peptide mixture used in some countries for stroke and cognition research; it is not FDA-approved in the United States, and a large Asian acute ischemic stroke RCT (CASTA) did not meet its primary endpoint.
A mixture of low-molecular-weight peptides and amino acids derived from purified porcine brain protein, marketed outside the US for neurological indications by Ever Neuro Pharma and studied mainly in stroke and dementia settings [R1].
Not FDA-approved for any US indication. Importation or compounding for unapproved uses remains a US regulatory risk; peptidex.ai does not advise on sourcing. Presence on research catalogs does not create an FDA approval.
Neurotrophic and neuroprotective claims are based largely on preclinical models; animal data are not clinical proof.
As a biologic peptide mixture, batch composition and immunogenicity are product-dependent. Allergic reactions and other adverse events are reported in clinical literature. Unregulated US "research" vials are not the EU-licensed product.
No US FDA approval pathway identified in this check. Readers should not confuse Cerebrolysin with FDA-approved stroke therapies.
Last checked 2026-10-27
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