Brain & sleep Neuropeptide preparation (porcine brain)
Cerebrolysin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Cerebrolysin is a preparation of small peptides and amino acids derived from pig brain, used in some countries for stroke and dementia and sold elsewhere for cognition. It has been tested in many human trials, but systematic reviews found no clear benefit on survival or function after stroke and only a weak, low-quality signal in vascular dementia. As of 2026 it is not FDA-approved in the United States.
At a glance
- FDA status
- Non-FDA-approved peptide preparation; approved in some other countries
- What it is
- Mixture of neuropeptides and amino acids from porcine brain, not a single defined peptide
- Research
- Substantial human trials, but reviews show no clear stroke benefit and only a weak dementia signal
- How it's taken
- By injection in the countries where it is used medically
- Evidence strength
- Low research
Summary
Cerebrolysin is a pig-brain peptide mixture used for stroke and dementia in some countries. See what trials show and why it is not FDA-approved.
What is cerebrolysin?
Cerebrolysin is a preparation of low-molecular-weight peptides and free amino acids produced from pig brain tissue. Cerebrolysin is also known as Cere and FPF-1070. It is not a single peptide but a mixture, and its exact composition is not fully defined. It is approved and used as an injectable in several countries for conditions such as stroke, dementia, and traumatic brain injury, and it is marketed more broadly for cognition. It is not approved in the United States.
How does it work?
Cerebrolysin is proposed to act like the brain's own neurotrophic factors, the signals that support the survival and function of nerve cells. In laboratory and animal models it has shown these effects:
- Neuroprotective
- Anti-apoptotic
- Anti-excitotoxic
Because the preparation is a complex mixture, its precise active components and mechanism are not fully characterized. This describes the proposed mechanism, separate from whether it improves outcomes in people.
Is it FDA-approved?
Safety note
Status: Non-FDA-approved peptide preparation; approved in some other countries
Category: Wellness and performance · Primary body area: Brain & sleep
No, not in the United States. Cerebrolysin is not approved by the FDA and is not an FDA-recognized compounding substance. It is used clinically in more than 50 countries, including parts of Europe, Russia and the CIS, China, and South Korea, for stroke, dementia, and brain-injury indications.
What does the research show?
Editor’s note
Evidence strength: Low research
Although it has many human trials and systematic reviews, those show no clear benefit on stroke survival or function and only a weak, low-quality, possibly non-meaningful signal in vascular dementia.
It has genuine human trials, and the pooled results are largely unfavorable. The main reviews reached these conclusions:
| Review | Finding | Certainty |
|---|---|---|
| Cochrane systematic review of acute ischemic stroke, according to PubMed | No beneficial effect on death, with a possible increase in non-fatal serious adverse events; many trials were manufacturer-supported | Moderate-certainty evidence |
| Separate Cochrane review in vascular dementia | A cognition and global-function signal, but any effect may be too small to be clinically meaningful | Very low quality evidence |
| Independent analysis of brain-derived nootropics | Similar modest conclusions | Low certainty |
So despite extensive testing, the human evidence does not establish a clear benefit.
Sources: Cochrane systematic reviews of cerebrolysin in acute ischemic stroke (Ziganshina et al., 2023, DOI: 10.1002/14651858.CD007026.pub7) and vascular dementia (Chen et al., 2019, DOI: 10.1002/14651858.CD008900.pub3), an independent review (Alsulaimani and Quinn, 2021, DOI: 10.1016/j.cccb.2021.100012), and animal studies of neuroprotection (Huang et al., 2014, DOI: 10.1016/j.kjms.2014.02.009), apoptosis (Rockenstein et al., 2006, DOI: 10.1007/s00401-006-0166-5), and excitotoxicity (Veinbergs et al., 2000, DOI: 10.1007/978-3-7091-6781-6_29), all indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
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- [10]
- [11]
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