Evidence brief
Cerebrolysin
Written and source-checked by Anthony Treviso, founder of The Peptide Field.
Direct answer
Cerebrolysin is not one peptide. It is a pig-brain-derived mixture of small peptides and amino acids. Human trials have studied it, but the largest stroke trial did not prove better recovery. No FDA-approved U.S. product was found.
An Austrian-authorized finished product made from a pig-brain peptide mixture, not one peptide. Human trials exist, but no FDA-approved U.S. product was identified.
- How strong is the evidence?
- Emerging
Some studies in people exist. Important questions remain about benefit, safety, who it helps, or how long the effects last. This is not an approval or recommendation. - What evidence exists?
- Investigational human outcomes
Studies measured health results in people, but the molecule is still being studied and is not approved for that use. Important questions remain. - Sports rules
- No prohibition identified
This review did not find a prohibition in the checked record. This does not clear you to compete.
Reviewed August 30, 2026. Sources and update notes are below.
No sales or dosing advice. This guide explains research. It was not independently medically reviewed, and it does not diagnose, prescribe, or recommend treatment.
Also known as Cerebrolysin Ebewe · Cerebrolyzin · FPE 1070 · FPE 1070 (IS) · FPF 1070 (IS) · Renacenz
Words used here
- peptide
- a short chain of amino acids
- amino acid
- a small building block that makes peptides and proteins
- investigational
- still being studied and not approved for that use
- outcome
- what the study measured
- molecule
- one specific chemical substance
- randomized
- assigned to study groups by chance
- placebo
- an inactive treatment used for comparison
- compounded
- made for one patient by a pharmacy, or in batches by a permitted outsourcing facility; a compounded drug is not FDA-approved
More detailProduct and study details
01 · Evidence profile
Four questions about the evidence
Randomized human studies include a large stroke trial and smaller dementia trials. The largest stroke trial found no significant difference on its main recovery measure.
Cerebrolysin is a mixture, not one defined molecule. Its product information says researchers cannot directly track the whole mixture through the body.
The stroke evidence found a possible increase in serious health problems that did not cause death. Product information also lists important warnings and adverse effects.
High for the named Austrian finished product; low for generic brain hydrolysates, compounded products, or products sold online.
02 · Identity
What it is
Cerebrolysin is not one peptide. It is a finished product made from a mixture of short peptides produced by breaking down pig-brain proteins in a controlled process. FDA's substance record lists pig brain protein as the source. It calls Cerebrolysin structurally diverse, which means it is a mixture rather than one molecule. The Austrian BASG product information describes an authorized finished product. Because it is a mixture, it has no single amino-acid sequence.
Scientific group: Pig-brain-derived peptide mixture. This group name describes the type of molecule or body signal. It does not prove a benefit, safety, or approval.
03 · Exact product
The molecule is not the finished product.
Formulation: The finished product's ingredients and physical form. Route: How the product enters the body. Indication: The approved or studied use and group of people for a product.
None identified in the United States.
- Human research after acute stroke
- Human research in vascular dementia and Alzheimer's disease
04 · Research results
What the research shows
CASTA was the largest randomized stroke trial. It enrolled 1,070 adults with a stroke caused by a blocked blood vessel. Its main recovery measure found no clear difference between Cerebrolysin and placebo. A 2023 Cochrane review covered seven studies and 1,773 people. It included one study of Cortexin, a similar product. The review found no clear drop in deaths. It found a possible rise in serious health problems that did not cause death.
A 2019 Cochrane review covered six vascular-dementia studies with 597 people. Study problems made the evidence very uncertain. Any benefit might be too small to matter. One Alzheimer's study included 192 people, but it did not settle the wider question. FDA has an identity record and an orphan drug designation for Cerebrolysin. Neither means product approval. No FDA-approved U.S. product was found. Online and related brain-peptide products are not proven equal to Cerebrolysin.
Exact product
Cerebrolysin is a specific finished product made from a pig-brain-derived peptide mixture. An FDA substance record and an Austrian authorization do not make every brain hydrolysate, compounded product, or online product equivalent to Cerebrolysin.
05 · Claim check
Claims I checked
4 claims checked for this brief.
“Cerebrolysin has been studied in randomized human trials.”
Yes. CASTA and other randomized studies tested the named product in defined groups and settings. The existence of these studies does not prove a benefit for every outcome or product.
- Evidence used
- Randomized human outcomes. This answer uses a study that assigned people to groups by chance and measured a health outcome.
- Limits of this answer
- The exact Cerebrolysin product, study group, comparison, outcome, and follow-up period in each randomized trial. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
“The largest randomized stroke trial proved that Cerebrolysin improves recovery.”
CASTA enrolled 1,070 adults, but its main combined recovery measure showed no significant difference between Cerebrolysin and placebo. A subgroup finding was not the main planned result and does not prove a general recovery benefit.
- Evidence used
- Randomized human outcomes. This answer uses a study that assigned people to groups by chance and measured a health outcome.
- Limits of this answer
- CASTA: adults with acute ischemic stroke studied for up to 90 days. The result applies to its planned primary measure and study population. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
“Cerebrolysin is FDA-approved in the United States.”
No FDA-approved U.S. Cerebrolysin product was identified in the reviewed approval database. An FDA substance record or orphan designation does not mean that FDA approved a product.
- Evidence used
- Regulatory or product record. This answer uses an official regulator record or a specific product label.
- Limits of this answer
- United States regulatory status as reviewed August 30, 2026. Austrian authorization is a separate country status. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
Show 1 more claim checks
“Every pig-brain peptide product is equivalent to Cerebrolysin.”
Cerebrolysin is a specific finished product and mixture. One 2015 sample contained 638 unique peptides. A 2024 study found different contents and activity in related products. A shared pig-brain source does not prove the same identity, contents, quality, or human evidence.
- Evidence used
- Regulatory or product record. This answer uses an official regulator record or a specific product label.
- Limits of this answer
- The named Austrian product and the exact product, process, composition, and quality record of any other preparation. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
06 · Questions
Questions people ask about Cerebrolysin
Authorized in Austria; no FDA-approved Cerebrolysin product was identified in the United States as reviewed August 30, 2026. No approved product is identified in the United States.
No prohibition identified. Cerebrolysin is not named in the reviewed 2026 WADA Prohibited List. The product is authorized in Austria, so it is not automatically in WADA's S0 group for substances with no government approval. This is not personal clearance. Athletes must check the current list and the rules that apply to their sport. This status is not personal clearance to compete.
CASTA was the largest randomized stroke trial. It enrolled 1,070 adults with a stroke caused by a blocked blood vessel. Its main recovery measure found no clear difference between Cerebrolysin and placebo. A 2023 Cochrane review covered seven studies and 1,773 people. It included one study of Cortexin, a similar product. The review found no clear drop in deaths. It found a possible rise in serious health problems that did not cause death.
A 2019 Cochrane review covered six vascular-dementia studies with 597 people. Study problems made the evidence very uncertain. Any benefit might be too small to matter. One Alzheimer's study included 192 people, but it did not settle the wider question. FDA has an identity record and an orphan drug designation for Cerebrolysin. Neither means product approval. No FDA-approved U.S. product was found. Online and related brain-peptide products are not proven equal to Cerebrolysin.
07 · Safety
Safety limits for this record
The available evidence does not define the full safety profile of every Cerebrolysin product or related mixture. The 2023 stroke review found a possible increase in serious health problems that did not cause death. This guide does not diagnose, treat, recommend, or provide product-use or sourcing instructions.
Cerebrolysin is not named in the reviewed 2026 WADA Prohibited List. The product is authorized in Austria, so it is not automatically in WADA's S0 group for substances with no government approval. This is not personal clearance. Athletes must check the current list and the rules that apply to their sport.
This review did not find a prohibition in the checked record. This does not clear you to compete.
Reviewed .Check current rules for tested sport ↗Open the governing record ↗08 · Sources
Read the sources
09 · Review history
Review history
Initial brief reviewed FDA identity and orphan-designation records, Austrian product information, randomized human trials, composition studies, and the 2026 World Anti-Doping Agency list.
Written and source-checked by Anthony Treviso, founder of The Peptide Field.
Not independently medically reviewed. This page is not a dosing, sourcing, or treatment guide.