Cerebrolysin

Summary

Cerebrolysin is a standardized mixture of small peptides and amino acids made from pig brain and sold as a neurotrophic drug in Austria, Russia, China, and dozens of other countries. Unlike most research peptides it has real randomized trials: a 1,070 patient acute stroke trial (CASTA) missed its primary endpoint, a 208 patient rehabilitation trial (CARS) found better arm function at 90 days, and Cochrane reviews rate the dementia evidence very low certainty and the stroke evidence as showing no mortality benefit with a possible increase in non-fatal serious adverse events. It has never been submitted to or approved by FDA and cannot be lawfully prescribed or compounded in the United States.

What is Cerebrolysin?

Cerebrolysin is an enzymatically digested porcine brain extract: a mixture of low molecular weight peptides (under 10 kDa) and free amino acids given by intravenous or intramuscular injection. It is also known as Cerebrolysin concentrate, Porcine brain derived peptide preparation, FPF 1070, Cerebrolysinum.

How does it work?

Cerebrolysin is proposed to mimic the effects of endogenous neurotrophic factors such as BDNF, NGF, and CNTF, supporting neuronal survival, neurite outgrowth, and neurogenesis, and reducing excitotoxicity and free radical damage after ischemia. Because it is an undefined mixture, no single active peptide has been identified and the neurotrophic hypothesis rests on cell culture and rodent models of ischemia and neurodegeneration rather than a confirmed molecular target in humans.

Cerebrolysin benefits: what the evidence shows

Multiple randomized placebo controlled trials exist, mostly industry supported and conducted in Europe and Asia. Acute ischemic stroke: CASTA (n = 1,070) found no difference on the combined primary endpoint at 90 days, with a post hoc trend in severe strokes. Post stroke rehabilitation: CARS (n = 208) found a large effect on Action Research Arm Test scores at day 90 (Mann-Whitney 0.71, 95% CI 0.63 to 0.79). The 2020 Cochrane review of 7 stroke trials (1,601 participants) found no difference in all-cause death (RR 0.90, 95% CI 0.61 to 1.32) and a possible increase in non-fatal serious adverse events (RR 2.15, 95% CI 1.01 to 4.55). Alzheimer's disease: a 2015 industry linked meta-analysis of 6 RCTs found a small cognitive benefit at 4 weeks (SMD minus 0.40) that was not significant at 6 months. Vascular dementia: the 2019 Cochrane review of 6 trials (597 participants) found small benefits rated very low certainty. Net: the grade is human RCT, but the effect is uncertain and likely small.

Human evidence

CASTA (2012): 1,070 patients with acute ischemic stroke randomized within 12 hours to 30 mL intravenous Cerebrolysin or saline daily for 10 days; the confirmatory combined endpoint (modified Rankin Scale, Barthel Index, NIHSS) at 90 days showed no significant difference, and a post hoc subgroup with NIHSS above 12 showed lower 90 day mortality (10.5% versus 20.2%). CARS (2016): 208 patients starting 24 to 72 hours after stroke, 30 mL daily for 21 days plus rehabilitation; Action Research Arm Test at day 90 favored Cerebrolysin with a Mann-Whitney estimator of 0.71. Alvarez et al. (2006): 279 patients with mild to moderate Alzheimer's disease randomized to 10, 30, or 60 mL or placebo for 12 weeks; only the 10 mL dose improved ADAS-cog at 24 weeks. Cochrane 2020 (7 trials, 1,601 participants) and Cochrane 2019 (6 trials, 597 participants) both judged the evidence to be low or very low certainty with high risk of bias and industry funding in most trials.

Animal evidence

Rodent models of focal ischemia, traumatic brain injury, and transgenic Alzheimer's disease report reduced infarct volume, less amyloid pathology, and improved behavioral recovery with Cerebrolysin, and cell culture work shows neurotrophic like effects on neuronal survival and neurite growth. These models informed the neurotrophic hypothesis but do not identify which peptides in the mixture are responsible.

Key studies

Conditions studied

Is Cerebrolysin legal in the United States?

FDA and compounding status

Cerebrolysin has never been submitted to or reviewed by FDA and is not an FDA approved drug. As an undefined biological mixture derived from animal brain it is not a bulk drug substance eligible for 503A or 503B compounding, and it has not been nominated to the 503A bulks list. It is a registered prescription drug in Austria (where it is manufactured), Russia, China, South Korea, and many other countries. Importing it for personal use in the United States is not lawful under FDA rules except in narrow circumstances that do not apply to routine use.

WADA status

Not WADA prohibited. Not named on the current prohibited list. Athletes should still confirm against the list in force for their season.

Regulatory timeline

No regulatory events recorded.

Full tracker for Cerebrolysin or the category-wide tracker.

What published studies of Cerebrolysin used

Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.

Trial regimens, all by intravenous infusion: 30 mL daily for 10 days starting within 12 hours of stroke (CASTA); 30 mL daily for 21 days starting 24 to 72 hours after stroke alongside rehabilitation (CARS); 10, 30, or 60 mL five days a week for 4 weeks then twice weekly for 8 weeks in Alzheimer's disease (Alvarez 2006). These are the regimens used in cited studies, not a recommendation, and none is approved in the United States.

Routes reported

Cerebrolysin side effects

Side effects

Interactions

Contraindications

How do people access Cerebrolysin legally?

Typical cost: Not available through licensed channels in the United States. In countries where it is approved, pharmacy prices are roughly 30 to 80 USD per 10 mL ampoule, so a 10 to 20 day course of 30 mL daily costs roughly 900 to 4,800 USD in drug alone. Prices noted on the last verified date and vary by country.

• Rules by state
• Verified provider directory

Compare Cerebrolysin

• Cerebrolysin vs Semax

What's actually offered, and what that means for you

Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. That does not make cerebrolysin lawful. Cerebrolysin is not FDA approved and not on the 503A bulks list, so a pharmacy has no lawful basis to compound it. [7] [11]

Enforcement is uneven. FDA mostly acts through warning letters to compounders and online sellers, Category 2 safety listings, and import alerts that let it detain shipments, rather than stopping every pharmacy. State pharmacy boards oversee pharmacies day to day, and their rules differ. [11] [12] [13] [14] [15]

What changes for you

• No FDA review of the product: FDA does not check a compounded drug's safety, effectiveness, or quality before it is sold. [15]
• Identity, purity, sterility, and dose accuracy can vary from batch to batch. [11]
• Insurance rarely covers it, so you usually pay cash.

What to check

These checks lower some risks, but they do not make an unlawfully compounded product lawful or safe. Check for:

• A 503A pharmacy licensed in your state (your state board of pharmacy publishes license lookups). [15]
• A real evaluation by a licensed prescriber, not just an online form.
• A certificate of analysis for the specific batch.

Frequently asked questions

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

Sources

Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.