- intravenous
- intramuscular
Cerebrolysin
Cerebrolysin (FPF-1070)
Cerebrolysin at a glance
Not on either FDA listHow studies gave it
Given into a vein, or injected into a muscle
Evidence on this page
5 peer-reviewed papers, published 2011 to 2021
FDA compounding lists
It appears on neither of the two FDA compounding tables.
What it is
Not a single peptide but a standardized enzymatic digest of porcine brain tissue (manufactured by EVER Neuro Pharma, Austria) comprising approximately 75% free amino acids and 25% low-molecular-weight neuropeptides, all below 10 kDa. The peptide fraction contains fragments resembling endogenous neurotrophins (BDNF, NGF, GDNF, CNTF), enkephalins, orexin-related peptides, and the P21 fragment.
Cerebrolysin has been studied in multiple randomized controlled trials for acute ischemic stroke, traumatic brain injury, Alzheimer's disease, and vascular dementia — representing one of the most clinically tested neuropeptide preparations in existence. It is approved in approximately 50 countries (not in the US or Canada) and has been administered to thousands of patients in clinical settings.
Primary RCT endpoints have produced mixed results, with some trials showing neutral primary outcomes but significant secondary or subgroup findings.
Published research
Multiple randomized controlled trials have examined Cerebrolysin across neurological indications. The CASTA trial (2012, n=1,070) studied 30 mL/day IV for acute ischemic stroke with a neutral primary endpoint but post-hoc signals in severe patients. The CARS trial (2016, n=208) found significant motor recovery improvement when combined with rehabilitation.
A meta-analysis of 6 Alzheimer's RCTs (Gauthier et al., 2015) reported significant cognitive improvement. The CAPTAIN TBI trial series (2021) showed small-to-medium effect sizes favoring Cerebrolysin at 90 days. A vascular dementia RCT (Guekht et al., 2011, n=242) found significant ADAS-cog improvement. Most trials were industry-funded.
A 2024 research integrity controversy affected some preclinical publications, though the major RCT data remains intact.
What the terms on this page mean7 termsHide
- peptide
- A short chain of amino acids, the building blocks of proteins.
- amino acid
- A building block that links with others to form peptides and proteins.
- endogenous
- Made by the body itself, rather than given from outside.
- BDNF
- Brain-derived neurotrophic factor, a protein involved in keeping nerve cells alive and forming new connections.
- NGF
- Nerve growth factor, a protein that supports the growth and survival of nerve cells.
- randomised controlled trial
- A trial that assigns people to treatment or control by chance, which is what lets it separate an effect from luck.
- preclinical
- Laboratory and animal work done before any testing in people.
Compounding status
Not on either FDA list- FDA listing
- Cerebrolysin appears on neither FDA's category 2 table nor its table of withdrawn nominations.
- What that means
- Absence from both lists is not permission to compound. Section 503A allows a bulk drug substance only where a USP or NF monograph exists, or the substance is a component of an FDA-approved drug product, or it appears on the 503A bulks list.
Source: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, FDA. Content current as of 2026-04-22; read 2026-09-05. This describes what a compounding pharmacy may supply. It is not advice about your own use.
Also given intravenous
- EpithalonEpithalon (Epitalon / AEDG Peptide)Nomination withdrawn
- GHRP-2Growth Hormone Releasing Peptide-2 (Pralmorelin)FDA category 2
- GHRP-6Growth Hormone Releasing Peptide-6FDA category 2
- IGF-1 DESdes(1-3) Insulin-like Growth Factor-1Not on either FDA list
- IGF-1 LR3Long R3 Insulin-like Growth Factor-1Not on either FDA list
- KisspeptinKisspeptin-10 / Kisspeptin-54 (Metastin)FDA category 2
Where this came from5 referencesHide
Each one was resolved at PubMed and confirmed to be the work this page cites. Author, title, journal and year come from the PubMed record, not from the page text.
- Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial
Heiss WD, et al.. Stroke (2012). PMID 22282884.
- Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial
Muresanu DF, et al.. Stroke (2016). PMID 26564102.
- Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials
Gauthier S, et al.. Dementia and geriatric cognitive disorders (2015). PMID 25832905.
- Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial
Guekht AB, et al.. Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association (2011). PMID 20656516.
- Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series
Vester JC, et al.. Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology (2021). PMID 33620612.
About this page
Reviewed 2026-08-11. This page reports what published studies and FDA documents say. It carries no dose, cycle length or stack, and it does not tell you whether a substance is appropriate for you. Side-effect reports circulating on forums are self-reported rather than measured, so they are not republished here.
See the editorial policy for how corrections are handled.