Cerebrolysin is an injectable mixture of short peptides and free amino acids made by controlled enzymatic digestion of pig brain protein. The Austrian company EVER Neuro Pharma markets it as a prescription drug for stroke, traumatic brain injury and dementia. It was given its current Austrian marketing authorization in 1996, and it is widely used in Russia, Eastern Europe, China and other Asian countries.
It is not a single molecule, and it is not a growth hormone or an anabolic agent. Cerebrolysin is not approved in the United States: the manufacturer itself states that it is not registered with the FDA and not approved for sale or distribution there. The evidence for benefit is contested. Manufacturer-supported trials and meta-analyses report gains in recovery, while the 2023 Cochrane review found no effect on death after stroke and a possible increase in non-fatal serious adverse events.
This page summarizes what the Austrian product information, clinical trials and systematic reviews report. It is for education only and is not medical advice.
| Property | Detail |
|---|---|
| Drug class | Peptide preparation from porcine brain protein, promoted as “neurotrophic” |
| Brand / holder | Cerebrolysin, EVER Neuro Pharma GmbH (Austria); Austrian authorization 1-21380, granted March 25, 1996 |
| Research code | FPF-1070 |
| Composition | 215.2 mg/mL of peptide concentrate in water, with sodium hydroxide |
| Route | Intravenous infusion or injection; intramuscular injection of small volumes |
| Labeled daily dose (Austria) | 10–30 mL for dementia; 20–50 mL for ischemic stroke and brain injury; 30–50 mL for hemorrhagic stroke |
| Half-life | Not measurable: the label states that direct pharmacokinetic measurement is not possible |
| US status | Not FDA approved; not named as a controlled substance |
| WADA status | Not named on the 2026 Prohibited List (see below) |
What it is
The Austrian Summary of Product Characteristics (SmPC) describes the active ingredient as a “proteolytic peptide fraction from pig brain protein,” at 215.2 mg per mL (Austrian SmPC, 2021). The only other ingredients listed are sodium hydroxide and water for injection. The Cochrane review describes it as roughly 80% low-molecular-weight peptides and 20% free amino acids (Ziganshina et al., Cochrane 2023).
The marketing claim is that Cerebrolysin acts like the brain’s own neurotrophic factors, the proteins such as BDNF (brain-derived neurotrophic factor) and NGF (nerve growth factor) that support nerve-cell survival and growth. A chemical analysis does not support the idea that it simply contains those factors:
- A Belgian lab analyzed an Internet-obtained Cerebrolysin sample by mass spectrometry and identified 638 distinct peptides (Gevaert et al., Drug Test Anal 2015).
- Most came from structural brain proteins: tubulin, actin and myelin basic protein.
- No fragments of BDNF, NGF, GDNF or CNTF were found. The authors suggested that any activity comes from as-yet-unidentified peptides.
Much of the mechanism data comes from animals and cell culture. The SmPC cites findings in animal models of stroke and dementia, such as smaller infarcts (areas of dead brain tissue) and less brain swelling. Early lab work used the code FPF-1070, for example in cultured chick-embryo neurons (Satou et al., J Neural Transm 2000). These findings do not show what the drug does in people.
Not the same as N-PEP-12. N-PEP-12 is a separate, oral, peptide-based nutritional supplement studied by some of the same research groups (Chira et al., Nutrients 2026). Results for one do not apply to the other.
Other peptides promoted for cognition, such as Semax and Selank, are single defined sequences with their own pages. Cerebrolysin is a mixture of hundreds of peptides from animal tissue.
Pharmacokinetics
Because the product is a mixture of short peptides that are “similar or identical” to those already in the body, the SmPC states that pharmacokinetic parameters cannot be measured directly. There is no labeled half-life (Austrian SmPC).
The label gives only indirect estimates, based on biological activity rather than drug levels:
| Label statement | Basis |
|---|---|
| Neurotrophic activity detectable in blood plasma up to 24 h after a single dose | Indirect: measured by effect, not drug concentration |
| Components cross the blood-brain barrier | Indirect: animal studies showed the same central effects after injection into the brain and after peripheral injection |
The product is labeled only for injection or infusion.
Approved medical use
The Austrian SmPC approves Cerebrolysin as supportive treatment of cerebrovascular disorders in adults and older adults, in particular:
- Alzheimer-type dementia and vascular dementia;
- deficits after stroke;
- traumatic brain injury (concussion and contusion).
Use in children and adolescents under 18 is not recommended because data are insufficient.
| Condition | Labeled daily dose | Labeled duration |
|---|---|---|
| Alzheimer-type and vascular dementia | 10–30 mL | 4 weeks (5 doses a week); courses may be repeated |
| Ischemic stroke | 20–50 mL | 10–21 days |
| Hemorrhagic stroke | 30–50 mL | 10–21 days |
| Traumatic brain injury | 20–50 mL | 7–30 days |
According to the label, up to 5 mL may be given intramuscularly and up to 10 mL intravenously. Larger amounts are given as a diluted intravenous infusion over about 15–60 minutes.
Regulatory status
- United States. Cerebrolysin is not FDA approved. The manufacturer’s website states that it “is not registered with the U.S. Food and Drug Administration” and is not approved for sale or distribution in the US (cerebrolysin.com). It is not listed among the Schedule III anabolic steroids (21 CFR 1308.13).
- Austria. A prescription-only, pharmacy-only medicine, authorization 1-21380.
- Elsewhere. Cochrane describes it as widely used for stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries.
- Sport. Cerebrolysin is not named on the WADA 2026 Prohibited List. The S0 “non-approved substances” class covers only substances with no current approval by any government health authority, and Cerebrolysin is approved in Austria. Whether it could fall under another class has not been settled in any source we found.
What the research shows
Most trials were run in stroke, traumatic brain injury and dementia. We found no controlled trials of Cerebrolysin for muscle growth, athletic performance or recovery from training, so there is no evidence for those uses.
A recurring issue is funding. Cochrane reviewers noted that the manufacturer supported three of the multicenter stroke trials, by funding them or by providing the drug, placebo, randomization codes or statisticians (Ziganshina et al., Cochrane 2023). Several authors of the CARS trial worked for EVER Neuro Pharma (Muresanu et al., Stroke 2016).
Acute ischemic stroke
The largest trial, CASTA, randomized 1,070 patients in Asia within 12 hours of stroke to Cerebrolysin 30 mL/day or saline for 10 days, on top of aspirin (Heiss et al., Stroke 2012). Its primary endpoint, a combined test of disability and neurological scores at 90 days, showed no significant difference. A post hoc analysis of patients with more severe strokes showed a trend in favor of Cerebrolysin, which the authors said needed confirmation.
Systematic reviews reach different conclusions:
| Review | Trials (participants) | Main finding |
|---|---|---|
| Cochrane 2023 (Ziganshina et al.) | 7 RCTs (1,773), incl. one of the related product Cortexin | All-cause death: RR 0.96 (95% CI 0.65–1.41), no difference. Non-fatal serious adverse events: RR 2.39 (95% CI 1.10–5.23) |
| Bornstein 2018 (Neurol Sci) | 9 RCTs (1,879) | Early neurological score (NIHSS, a stroke severity scale) favored Cerebrolysin; number needed to treat 7.7 (95% CI 5.2–15.0) for a clinically relevant improvement |
| Strilciuc 2021 (Pharmaceuticals) | 12 RCTs (2,202) | No significant difference in safety outcomes vs placebo |
The Cochrane review rated the evidence on death and serious adverse events as moderate certainty. It concluded that Cerebrolysin probably does not prevent death after ischemic stroke. None of the included trials reported death or dependence at the end of follow-up, quality of life, or return to work.
Recovery and rehabilitation after stroke
The CARS trial randomized 208 patients to Cerebrolysin 30 mL/day or saline for 21 days, starting 24–72 hours after stroke, alongside a standard rehabilitation program (Muresanu et al., Stroke 2016).
| Outcome at day 90 | Result |
|---|---|
| Arm function (Action Research Arm Test) | Mann-Whitney estimator 0.71 (95% CI 0.63–0.79) in favor of Cerebrolysin |
| Global status across 12 scales | Mann-Whitney estimator 0.62 (95% CI 0.58–0.65) |
| Serious adverse events | 2.9% Cerebrolysin vs 6.7% placebo |
A Mann-Whitney estimator of 0.5 means no difference between groups. The authors called the study exploratory and said a large trial was needed to confirm the result.
Traumatic brain injury
The CAPTAIN II trial randomized 142 patients with moderate to severe brain injury, at a single center, to Cerebrolysin or placebo in addition to standard care (Muresanu et al., Neurol Sci 2020). The regimen was 50 mL/day for 10 days, followed by two cycles of 10 mL/day for 10 days. A combined endpoint of 13 outcome scales showed a “small-to-medium” effect at day 90 (Mann-Whitney 0.59, 95% CI 0.52–0.66).
A planned meta-analysis of the CAPTAIN trials (185 patients) reported a similar small-to-medium effect at days 30 and 90 (Mann-Whitney 0.60 at both) (Vester et al., Neurol Sci 2021). These are small trials that used composite, multi-scale endpoints. Neither reports a single clinical outcome such as death or independent living.
Dementia
Vascular dementia. A 2019 Cochrane review found 6 trials with 597 participants (Cui et al., Cochrane 2019):
| Outcome | Effect | Certainty |
|---|---|---|
| Cognition (MMSE or ADAS-cog+, 3 trials, 420 people) | SMD 0.36 (95% CI 0.13–0.58) | Very low |
| Global function response (2 trials, 379 people) | RR 2.69 (95% CI 1.82–3.98) | Very low |
| Adverse events (2 trials, 379 people) | RR 0.91 (95% CI 0.29–2.85) | Very low |
The reviewers said the included studies had a high risk of bias. Any benefit “may be too small to be clinically meaningful.”
Alzheimer’s disease. A meta-analysis of 6 placebo-controlled trials of 30 mL/day in mild to moderate Alzheimer’s disease reported better cognition at 4 weeks (SMD −0.40, 95% CI −0.66 to −0.13) but not at 6 months (Gauthier et al., Dement Geriatr Cogn Disord 2015). Global clinical change favored Cerebrolysin at both time points.
In a 24-week dose-finding trial, 279 patients received 10, 30 or 60 mL or placebo, given 5 days a week for 4 weeks and then twice weekly for 8 weeks (Alvarez et al., Eur J Neurol 2006). Only the 10 mL dose significantly improved cognition. The 30 and 60 mL doses improved only the global rating, and the authors described an inverted-U dose response.
Side effects and risks
Labeled adverse effects
The Austrian SmPC lists the following, all as rare or very rare:
| Frequency | Reported effects |
|---|---|
| Rare | Loss of appetite; agitation (aggression, confusion, insomnia); dizziness with too-rapid administration; feeling hot or sweating, mainly with rapid injection; itching |
| Very rare (under 1 in 10,000) | Allergic reactions, including fever, chills, shortness of breath and a shock-like state; isolated grand mal seizures; palpitations or arrhythmia with too-rapid administration; nausea, vomiting, diarrhea or constipation; redness, itching or burning at the injection site |
Serious adverse events in stroke trials
The 2023 Cochrane review found no difference in the total number of people with serious adverse events (RR 1.16, 95% CI 0.81–1.66). Within that total, non-fatal serious adverse events were more common with Cerebrolysin (RR 2.39, 95% CI 1.10–5.23; 3 trials, 1,335 participants). The increase was larger with 30 mL/day for 10 days (RR 2.87, 95% CI 1.24–6.69). A separate meta-analysis of 12 trials found no significant safety difference (Strilciuc et al., 2021). The two reviews used different sets of trials.
Seizures and other contraindications
The label lists these contraindications:
- hypersensitivity to any component;
- status epilepticus (a prolonged, continuous seizure);
- severe kidney impairment.
The label also advises caution in people with allergies or epilepsy, because seizure frequency may increase. It should not be used in pregnancy unless the woman’s condition requires it.
Interactions
- Antidepressants and MAO inhibitors: the label warns of additive effects and suggests a lower antidepressant dose. Cerebrolysin at 30–40 mL with high doses of MAO inhibitors may raise blood pressure.
- Amino acid solutions: it should not be given in the same infusion as balanced amino acid solutions.
Products from outside the regulated supply
In the US, any Cerebrolysin is sold outside the FDA-regulated drug supply. The 2015 mass-spectrometry study analyzed a sample bought on the Internet, which shows that the product circulates online (Gevaert et al., 2015). It is a parenteral product made from animal tissue, and its composition cannot be checked by the buyer.
Key takeaways
- A pig-brain peptide mixture, not a single drug. It contains hundreds of short peptides and amino acids. Mass spectrometry found no fragments of known neurotrophic factors.
- Approved in Austria and elsewhere, not in the US. The manufacturer states it is not FDA registered or approved for US sale.
- No measurable half-life. The label says conventional pharmacokinetics cannot be measured for this mixture.
- Contested evidence in stroke. CASTA, the largest trial, missed its primary endpoint, and Cochrane found no effect on death. Smaller, largely manufacturer-supported trials report better recovery scores.
- Low-certainty evidence in dementia and brain injury. Effects are small, the trials are at high risk of bias, and the benefit may not be clinically meaningful.
- No evidence for muscle or performance. No controlled trials have tested it for training recovery or athletic use.
Sources
- EVER Neuro Pharma GmbH. Cerebrolysin – parenterale Lösung: Zusammenfassung der Merkmale des Arzneimittels (Austrian SmPC), authorization 1-21380, March 2021. EVER Pharma.
- EVER Neuro Pharma GmbH. Cerebrolysin: notice to U.S. visitors. cerebrolysin.com.
- Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023;10(10):CD007026. PubMed.
- Gevaert B, D’Hondt M, Bracke N, et al. Peptide profiling of Internet-obtained Cerebrolysin using high performance liquid chromatography - electrospray ionization ion trap and ultra high performance liquid chromatography - ion mobility - quadrupole time of flight mass spectrometry. Drug Test Anal. 2015;7(9):835–842. PubMed.
- Satou T, Itoh T, Tamai Y, et al. Neurotrophic effects of FPF-1070 (Cerebrolysin) on cultured neurons from chicken embryo dorsal root ganglia, ciliary ganglia, and sympathetic trunks. J Neural Transm (Vienna). 2000;107(11):1253–1262. PubMed.
- Chira D, Jemna N, Verișezan-Roșu O, et al. Impact of N-PEP-12 supplementation on attentional performance and mental wellbeing in healthy adults with subjective cognitive complaints: a randomized, placebo-controlled trial. Nutrients. 2026;18(16):2739. PubMed.
- Heiss WD, Brainin M, Bornstein NM, et al. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial. Stroke. 2012;43(3):630–636. PubMed.
- 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):151–159. PubMed.
- Bornstein NM, Guekht A, Vester J, et al. Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials. Neurol Sci. 2018;39(4):629–640. PubMed.
- Strilciuc S, Vécsei L, Boering D, et al. Safety of Cerebrolysin for neurorecovery after acute ischemic stroke: a systematic review and meta-analysis of twelve randomized-controlled trials. Pharmaceuticals (Basel). 2021;14(12):1297. PubMed.
- Muresanu DF, Florian S, Hömberg V, et al. Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial. Neurol Sci. 2020;41(5):1171–1181. PubMed.
- Vester JC, Buzoianu AD, Florian SI, et al. Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series. Neurol Sci. 2021;42(11):4531–4541. PubMed.
- Cui S, Chen N, Yang M, et al. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019;2019(11):CD008900. PubMed.
- Gauthier S, Proaño JV, Jia J, et al. Cerebrolysin in mild-to-moderate Alzheimer’s disease: a meta-analysis of randomized controlled clinical trials. Dement Geriatr Cogn Disord. 2015;39(5-6):332–347. PubMed.
- Alvarez XA, Cacabelos R, Laredo M, et al. A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer’s disease. Eur J Neurol. 2006;13(1):43–54. PubMed.
- World Anti-Doping Agency. The 2026 Prohibited List. WADA 2026 Prohibited List.
- US Code of Federal Regulations. 21 CFR 1308.13, Schedule III. 21 CFR 1308.13.