Cerebrolysin: Benefits, Dosage and Side Effects
Cerebrolysin: a porcine brain-derived peptide mixture approved abroad for stroke and dementia. What Cochrane says, trial dosing, side effects and legal status.
The short version
Cerebrolysin is a mixture of peptide fragments and amino acids, not a single peptide, made by breaking down pig brain tissue. It is a prescription drug in dozens of countries for stroke, brain injury and vascular dementia, but has never been FDA-approved. Cochrane's review of acute stroke found no survival benefit and a probable rise in serious side effects; a separate review found a modest, weak-evidence benefit in vascular dementia.
- Cerebrolysin is a pig-brain peptide mixture, not one defined molecule, and its make-up varies by batch.
- A prescription drug in Russia, China and other markets; never FDA-approved in the US.
- Cochrane's 2023 review of acute stroke found no survival benefit and more serious side effects.
- A separate Cochrane review found a weak-evidence benefit on cognition in vascular dementia.
- Normally given by a clinician as a monitored IV infusion or muscle injection, not self-injected from a research vial.
Cerebrolysin at a glance
- What it is
- Porcine brain-derived peptide preparation (a mixture of low-molecular-weight peptides and free amino acids), not a single defined peptide
- Main use
- A prescription drug in Russia, China, several Eastern European and other markets for acute ischaemic stroke, traumatic brain injury and vascular dementia. Also sold outside those markets, including to US buyers, as an unregulated "research" or grey-market vial for self-injection, which is not how it is used where it is actually approved.
- Also called
- Cerebrolysin Injection, FPF-1070
- Evidence
- Limited human data
- US status
- Unapproved drug
- Australia
- Not on the ARTG
- Half-life
- Not established in humans
- Dose
- No consistent protocol in circulation Dosing page
Cerebrolysin is not a single peptide. Every other peptide on this site is one molecule with one known sequence. Cerebrolysin is a mixture of small peptide fragments and free amino acids, made by breaking down pig brain tissue with enzymes. Its exact contents vary from batch to batch in a way a synthesised peptide’s don’t.
It also has something almost nothing else here has: decades of use as a prescription drug in other countries and a large record of randomised human trials. Those trials are encouraging in vascular dementia and early stroke rehabilitation, but Cochrane found no survival benefit in acute stroke.
Dosing: what the published trials used.
What is Cerebrolysin?
Manufacturers describe it as a proprietary enzyme-digested extract (hydrolysate) of pig brain proteins, standardised for total peptide content rather than for any one active ingredient. It has been sold since the 1970s outside the US, mainly as an injectable neurology drug.
How Cerebrolysin works
Because it is a mixture, “how it works” is a hypothesis about many components acting together, not a single receptor story. Researchers attribute nerve-supporting (neurotrophic) and protective effects to fragments in the mix that behave like nerve growth factor and BDNF. They also propose reduced inflammation in the brain.
That idea comes from lab and animal work on the extract’s components. It is why Cerebrolysin has been tested in human trials, but it is not evidence that it works.
Cerebrolysin benefits: what the research shows
Small or uncontrolled human studies. Too little to settle the question either way. Cerebrolysin has an unusually large human randomised-trial record for a compound on this site, including two current Cochrane systematic reviews. But the results differ by condition, and the highest-quality review, for the use it is most marketed for, is negative.
This is the rare compound here with a large human trial record, and that record points in more than one direction:
- Acute ischaemic stroke, its best-known use. A 2023 Cochrane systematic review of 7 randomised trials found moderate-certainty evidence that cerebrolysin probably doesn’t prevent death and probably increases the number of people with a non-fatal serious adverse event Ziganshina 2023 - Ziganshina LE, Abakumova T, Nurkhametova D et al. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023;10(10):CD007026., in the references below. Cochrane reviews weigh all eligible trials together, which is why this result carries weight.
- Early stroke rehabilitation, a different group and timing. One randomised, placebo-controlled trial reported better motor function and overall outcome. Its authors called the result exploratory and asked for larger trials to confirm it Muresanu 2016 - Muresanu DF, Heiss WD, Hoemberg V et al. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016;47(1):151-9., in the references below.
- Vascular dementia. Cochrane’s 2019 review of 6 randomised trials and 597 participants reported a benefit on cognition and function, but rated the evidence weak and at high risk of bias Cui 2019 - Cui S, Chen N, Yang M et al. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019;2019(11)., in the references below.
Cerebrolysin dosage
No dose is set for self-administered use, and grey-market guides disagree on route, dose and unit. Published trials gave it as an IV infusion run by a clinician, commonly 10-50 mL a day depending on the condition, over a 10-21 day course. Full sourcing and the trial-by-trial breakdown: Cerebrolysin dosage.
Cerebrolysin side effects
Apart from that signal, trials in other conditions and in its approved markets generally describe it as reasonably well tolerated at clinical doses. As an extract from animal tissue, it carries allergy and injection-site risks that a synthesised peptide of known purity doesn’t.
Get emergency care for signs of a severe allergic reaction (swelling of the face, lips, tongue or throat, or difficulty breathing) or any severe or rapidly worsening symptom after an injection.
Is Cerebrolysin legal?
US legal status - Unapproved drug
Not approved by the FDA for any use. Marketing it for human use in the US is unlawful, regardless of how it is labelled.
AU legal status - Not on the ARTG
Not on the Australian Register of Therapeutic Goods, so the TGA has not assessed it for safety, quality or effectiveness. Goods that are not on the ARTG cannot lawfully be supplied or advertised in Australia except through a specific pathway - the Special Access Scheme, an Authorised Prescriber, a clinical trial, or personal importation.
Regulators reach their own conclusions on their own timelines. Where these two disagree, the difference is the point - not an error.
- Not FDA-approved for anything in the US. A DailyMed search for “cerebrolysin” returns no results, so there is no US drug label.
- A prescription drug elsewhere. It is approved and used in Russia, China and a number of other markets for stroke, traumatic brain injury and vascular dementia. That approval doesn’t make it approved, or legal to import for personal use, in the US.
- Not on Australia’s register. It isn’t on the Therapeutic Goods Administration’s Australian Register of Therapeutic Goods. Unapproved access there runs only through the TGA’s Special Access Scheme or Authorised Prescriber pathways.
- Grey-market vials. Outside its approved markets it is sold by research-chemical and grey-market vendors as a self-injection vial, without the manufacturing oversight it has as a clinician-given drug.
Related reading
How Cerebrolysin compares
Brain, mood and sleep. Doses for unapproved compounds are common practice, not trial-established. All brain, mood and sleep peptides →
| Compound | Main use | Evidence | Usual dose | US status |
|---|---|---|---|---|
| Semax | Sold as a nootropic for focus, memory and mood. Used clinically within Russian medicine. | Limited human data | 100-600 mcg, once daily for a fixed telehealth-prescribed protocol, up to twice daily in a wider clinic-published range | Research use only |
| Selank | Sold as a nootropic for focus, memory and mood. Used clinically within Russian medicine. | Limited human data | 250-900 mcg, 1-3 times daily, spaced through waking hours; the published Russian GAD clinical-trial protocol used a fixed 3 times daily schedule (900 mcg per dose, 2.7 mg/day total) for a 14-day course | Research use only |
| Adamax | Sold as a nootropic, marketed as a longer-acting, more potent successor to Semax, aimed at the same cognitive-enhancement buyers. | No meaningful evidence | No consistent protocol | Unapproved drug |
| Cerebrolysin | A prescription drug in Russia, China, several Eastern European and other markets for acute ischaemic stroke, traumatic brain injury and vascular dementia. Also sold outside those markets, including to US buyers, as an unregulated "research" or grey-market vial for self-injection, which is not how it is used where it is actually approved. | Limited human data | No consistent protocol | Unapproved drug |
| PE-22-28 | Studied only in mice as a candidate fast-acting antidepressant. Never tested in a single published human trial, and sold to consumers as an unregulated research-chemical mood/depression product. | Animal / lab only | No consistent protocol | Unapproved drug |
| Dihexa | Sold online as a research chemical for cognition and memory. FDA has not identified any human exposure data on drug products containing dihexa acetate by any route. | Animal / lab only | 10-100 mg, 1 to 3 times a week, not daily; sources describe starting around 10-20 mg and titrating up to 50-100 mg as tolerated | Research use only |
| DSIP | Sold for sleep. Named in the 1970s after a proposed role in promoting delta-wave sleep. | Limited human data | 100-500 mcg, once nightly, 30-60 minutes before intended sleep onset; anywhere from 5-14 nights a month to nightly use depending on the protocol | Research use only |
Where to buy Cerebrolysin for research
Each vendor is checked against my vendor checklist.
1.Next Level PharmFeatured
60 mg vial
- No FDA warning letter found
- Names its testing lab
- Batch COAs published
- Takes card payment
2.BioEdge Research Labs
30 mg vial
- No FDA warning letter found
- Names its testing lab
- Batch COAs published
Common questions
What is the usual Cerebrolysin dose?
No regulator has set a dose for self-administered use, and grey-market guides disagree on route, dose and even the unit. Published trials gave it as an IV infusion run by a clinician, most often 10-50 mL a day depending on the condition, over 10-21 days. See the dosing page for trial-by-trial detail.
What are the side effects of Cerebrolysin?
Cochrane's 2023 review of acute stroke, covering 7 randomised trials, found that cerebrolysin probably increases the number of people with a non-fatal serious adverse event, without reducing deaths. Full detail is on the dosing and guide pages.
Is Cerebrolysin available in the US?
Not as an approved medicine. It is not FDA-approved, and DailyMed has no US label for it. US buyers find it through research-chemical and grey-market vendors as a self-injection vial, without the manufacturing oversight it has where it is approved and given by clinicians.
Why is Cerebrolysin not FDA approved?
I found no FDA statement giving a reason. What I can confirm is that DailyMed lists no US label, so no product under this name has been approved here. The evidence is also mixed: no survival benefit and more serious side effects in acute stroke, only a weak-evidence benefit in vascular dementia, and a make-up that varies by batch. Approval in other countries doesn't carry over to the US.
Is Semax the same as Cerebrolysin?
No. Semax is a single synthetic peptide with one defined sequence, derived from a fragment of ACTH. Cerebrolysin is a mixture made from pig brain tissue, and its make-up varies by batch. Both are used clinically in Russia and marketed for cognition elsewhere, and neither is FDA-approved. [Semax](/semax/) has its own page.
What are the risks of Cerebrolysin?
Cochrane's acute-stroke review found it probably increases non-fatal serious adverse events without reducing deaths. As an animal-tissue extract it carries allergy and injection-site risks, and its make-up varies by batch. No regulator checks that a grey-market vial matches its label or is sterile. Where it is approved, a clinician gives it as a monitored IV infusion or muscle injection.
What well-known people have said about Cerebrolysin
Public statements, shown because people search for them. Each is one person's account, in their words or a faithful summary, with where and when they said it. None of it is evidence that Cerebrolysin works or is safe; that is what the rest of this page is for.
Bryan Johnsonentrepreneur, founder of BlueprintSaid they tried it
In the same post Johnson named Cerebrolysin among the peptides he had experimented with. He added that research on many peptides is limited.
Post on X (@bryan_johnson), 1 April 2025. Source: X (@bryan_johnson)
Photo: M Robertson, CC BY 4.0, via Wikimedia Commons
References (4 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.Ziganshina LE, Abakumova T, Nurkhametova D et al. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023;10(10):CD007026.Systematic reviewPMID 37818733full text
- 2.Muresanu DF, Heiss WD, Hoemberg V et al. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016;47(1):151-9.Randomised trialPMID 26564102full text
- 3.Cui S, Chen N, Yang M et al. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019;2019(11).Meta-analysisPMID 31710397full text
- 4.DailyMed search for "cerebrolysin" - zero results, confirming no FDA-approved US drug label exists.- DailyMed, US National Library of Medicinedatabase