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Not FDA-approved
Brain & sleep
Cerebrolysin
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.
- Reviewed by
- William Maish, MD MBA MPH, Clinical Product Lead
- Published
- April 18, 2026
- Last updated
- October 5, 2026
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.
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:
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?
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 countries4, including parts of Europe, Russia and the CIS, China, and South Korea, for stroke, dementia, and brain-injury indications.
What does the research show?
It has genuine human trials, and the pooled results are largely unfavorable. The main reviews reached these conclusions:
| Review | Finding | Certainty |
| Cochrane systematic review5 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 review6 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 analysis7 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.pub75) and vascular dementia (Chen et al., 2019, DOI: 10.1002/14651858.CD008900.pub36), an independent review (Alsulaimani and Quinn, 2021, DOI: 10.1016/j.cccb.2021.1000127), and animal studies of neuroprotection (Huang et al., 2014, DOI: 10.1016/j.kjms.2014.02.0091), apoptosis (Rockenstein et al., 2006, DOI: 10.1007/s00401-006-0166-52), and excitotoxicity (Veinbergs et al., 2000, DOI: 10.1007/978-3-7091-6781-6_293), 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.