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Cerebrolysin · Dose evidence · updated 8 October 2026

Cerebrolysin dosage: what studies actually used

The short answer

Cerebrolysin is not a single peptide but a prescription mixture of small peptides and amino acids from pig brain, so its doses are volumes of the product in mL1011. It is licensed in nine EU countries, including Austria, and in others such as Russia and China, but not in the US111213. The maker’s guide for health professionals lists 20 to 50 mL a day for 10 to 21 days after a stroke, 20 to 50 mL a day for 7 to 30 days after a brain injury, and 10 to 30 mL a day, 5 days a week for 4 weeks, 2 to 4 times a year, for Alzheimer’s disease and other cognitive problems14. The largest trial, CASTA, randomized 1,070 stroke patients to 30 mL a day or placebo for 10 days and found no significant difference on its main outcome15.

Not dosing advice. This page reports doses that studies and approved labels used, with their sources. It does not recommend a dose, and we do not give mixing, injection or unit-conversion instructions. Gray-market vials often do not contain what their label says. How we report doses.

Every dose studied in people

StudyWhoPeopleDose and routeWhat happened
CASTA (Heiss 2012), randomized, placebo-controlled Patients in Asia within 12 hours of an ischemic stroke; 529 got Cerebrolysin and 541 a saltwater placebo, all with aspirin 100 mg a day 1,070 30 mL a day
Infusion into a vein · 10 days		 No significant difference between the groups on the main combined outcome at 90 days1516. In a post hoc look at more severe strokes, deaths by day 90 were 10.5% on Cerebrolysin and 20.2% on placebo, a trend the authors said should be confirmed in another trial15.
CEREHETIS (Khasanova 2023), randomized open-label pilot with no placebo; only the radiologists reading scans were blinded Patients at 8 Russian centers given the clot-dissolving drug alteplase for an ischemic stroke; 126 also got Cerebrolysin and 215 alteplase alone 341 30 mL a day, starting together with alteplase
Infusion into a vein · 14 days		 Symptomatic bleeding into the damaged brain area was less common with Cerebrolysin (odds ratio 0.248), and stroke severity scores were lower at day 14, but disability at day 90 did not differ1. No serious adverse events were attributed to Cerebrolysin1.
Alvarez 2006, randomized, placebo-controlled, three doses People with mild to moderate Alzheimer’s disease; 69, 70 and 71 on the three doses and 69 on placebo 279 10, 30 or 60 mL per infusion
Infusion into a vein · 5 days a week for 4 weeks, then twice a week for 8 weeks		 At week 24, 10 mL improved both thinking scores (ADAS-cog, P=0.038) and the overall clinical impression, while 30 and 60 mL improved only the overall impression; the authors called this a reversed U-shaped dose response17. Adverse events were reported at similar rates in all groups17.
Guekht 2011, randomized, placebo-controlled People with vascular dementia, all also taking aspirin 242 20 mL once a day
Into a vein (IV) · 2 treatment cycles; results at 24 weeks		 At week 24, thinking scores (ADAS-cog+) improved by 10.6 points on Cerebrolysin and 4.4 on placebo, and the overall clinical impression also favored Cerebrolysin18. The authors reported that it was safe and well tolerated18.
Alvarez 2011, randomized, double-blind comparison with donepezil People with mild to moderate Alzheimer’s disease; the paper reports 64 on Cerebrolysin, 66 on donepezil (an Alzheimer’s drug taken by mouth) and 67 on both 217 10 mL per infusion, 5 days a week
Infusion into a vein · 4 weeks, repeated after a 2-month break		 At week 28, thinking, daily-living and behavior scores did not differ significantly between the groups, while the overall clinical impression favored Cerebrolysin and the combination2. The authors concluded that Cerebrolysin was as effective as donepezil2. The maker sponsored the trial, and its registry record lists 217 people enrolled and 40 infusions in all3.
CARS (Muresanu 2016), randomized, placebo-controlled People aged 18 to 80 in Romania, Ukraine and Poland, 24 to 72 hours after an ischemic stroke, all in a 21-day rehabilitation program; 104 per group 208 30 mL a day
Infusion into a vein · 21 days		 Arm function at day 90 favored Cerebrolysin, with a Mann-Whitney estimator of 0.71: the chance that a treated patient did better than one on placebo, where 0.5 means no difference19. Serious adverse events occurred in 3 patients on Cerebrolysin and 7 on placebo, none judged related to the drug, and the authors called the maker-funded trial exploratory19.
Panisset 2002, randomized, placebo-controlled People with Alzheimer’s disease; 97 got Cerebrolysin and 95 placebo 192 30 mL, 5 days a week
Into a vein (IV) · 4 weeks		 At week 12, the overall clinical impression favored Cerebrolysin (p = 0.033), with 76% responders against 57% on placebo, though the groups differed at the start in age and other traits4. Adverse events were recorded in 64% of the Cerebrolysin group and 73% of the placebo group4.
Ruether 2001, randomized, placebo-controlled People with mild to moderate Alzheimer’s disease; 76 got Cerebrolysin and 73 placebo 149 30 mL, 5 days a week
Infusion into a vein · 4 weeks, repeated after a 2-month break		 At week 16, 63.5% responded on a global rating against 41.4% on placebo, and thinking scores (ADAS-cog) differed by 3.2 points in favor of Cerebrolysin; the gains largely held at week 285. Adverse events were recorded in 43% of the Cerebrolysin group and 38% of the placebo group5.
Ladurner 2005, randomized, placebo-controlled People within 24 hours of an acute stroke, all also given aspirin and pentoxifylline; 78 got Cerebrolysin and 68 placebo 146 50 mL a day
Into a vein (IV) · 21 days		 Cerebrolysin brought no significant gain on a neurological scale, a daily-living index or the overall clinical impression, though one cognitive test, the Syndrome Short Test, improved6. Adverse events were about as frequent in both groups6.
CAPTAIN II (Muresanu 2020), randomized, placebo-controlled, one center People with moderate to severe traumatic brain injury, on top of standard care; 142 enrolled and 139 analyzed 142 50 mL a day, then 10 mL a day
Route not stated in the abstract · 10 days, then two more 10-day cycles		 Across 13 combined outcome scales at day 90, the effect favored Cerebrolysin and was ‘small-to-medium’ (combined Mann-Whitney estimator 0.59), and safety was comparable to placebo20.
Lang 2013, randomized, placebo-controlled People within 3 hours of an ischemic stroke, all given alteplase 119 30 mL a day, starting 1 hour after alteplase
Infusion into a vein · 10 days in a row		 The trial was stopped after a third interim analysis showed no benefit on disability at day 907. On the NIH stroke scale, more patients on Cerebrolysin improved by 6 or more points, or reached a score of 0 or 1, at days 2, 5, 10 and 30, and adverse events did not differ7.
Funke 1998, randomized, placebo-controlled Healthy men 48 10, 30 or 50 mL per infusion
Infusion · 10 days		 Brain-wave (EEG) changes were seen mainly at 10 and 30 mL21. Signs of overdose appeared at the highest doses but were mild and caused no harm, and the highest dose caused a small but significant drop in blood pressure21.
CAPTAIN I (Poon 2020), randomized, placebo-controlled People with moderate to severe traumatic brain injury in Asia and the Pacific, on top of standard care; 22 got Cerebrolysin and 24 placebo 46 50 mL a day, then 10 mL a day
Infusion into a vein · 10 days, then two more 10-day cycles		 The main combined outcome just missed significance among all randomized patients (combined Mann-Whitney estimator 0.63) but reached it among those treated as planned (0.69), and safety was comparable to placebo8. The maker sponsored the trial, which stopped early because too few patients enrolled9.

Studies, animals and users: kept apart

Doses below are what studies used or what a label says. They are not advice, and gray-market products may not contain what their label says.

In human studies

Licensed use, from the maker’s dosing guide for health professionals: stroke 20 to 50 mL a day for 10 to 21 days; brain injury 20 to 50 mL a day for 7 to 30 days; cognitive problems and Alzheimer’s disease 10 to 30 mL a day, 5 days a week for 4 weeks, repeated 2 to 4 times a year14. It is given into a vein, by injection or infusion, or up to 5 mL at a time into a muscle14. Trials: 30 mL a day into a vein for 10 days in CASTA15; 30 mL a day for 21 days in CARS19; 20 mL a day in two treatment courses in vascular dementia18; 10, 30 or 60 mL, 5 days a week for 4 weeks and then twice a week for 8 weeks, in Alzheimer’s disease, where 10 mL did best on cognition17. Healthy men received 10, 30 or 50 mL by infusion for 10 days, and mild signs of overdose occurred at the highest doses21. We found no trial of the small self-injections described online.

In animal studies

As reported, in rats only. Rats with an embolic stroke: 0.8, 2.5, 5.0 or 7.5 mL/kg a day for 10 days, starting 4 hours after the stroke; 2.5 mL/kg or more improved recovery, and 5 mL/kg reduced the damaged area23. Rats with sudden or long-term reduced blood flow to the brain: 538 or 1,614 mg/kg a day for 10 days24. These are animal research doses, not human doses, and we do not convert them.

What users report Anecdotal · not validated · not a recommendation

Buyer reviews posted in 2025 on one seller’s page describe 1 to 10 mL at a time, often daily; the seller says it is not able to recommend doses because the product is not FDA-approved22.

Half-life and how it is taken

Routes
  • Infusion into a vein (licensed; the route in the trials cited here)
  • Injection into a vein of up to 10 mL (licensed)
  • Injection into a muscle of up to 5 mL (licensed)
  • Self-injection at home, described in online buyer reviews (no trial of this use found)

Where Cerebrolysin is licensed

The European Medicines Agency’s database, with data as of 21 September 2026, lists Cerebrolysin from EVER Neuro Pharma in nine EU countries: Austria, where it is also authorized as Ambotonin and Cerebrotonin, Bulgaria, Croatia, the Czech Republic, Latvia, Lithuania, Poland, Romania and Slovakia, for use into a muscle or a vein12. Outside the EU, a 2024 case report lists China, Russia and South Korea among the countries where it is approved, and the authors of a maker-funded 2025 study wrote that it is approved in about 60 countries1325. We did not check national drug registers outside the EU. The maker says it is not registered with FDA and is not approved for sale in the US11.

The maker’s prescribing information, based on Austria’s official summary of product characteristics, lists Alzheimer-type dementia, vascular dementia, stroke and head injury as its uses, says it is prescription-only, and rules it out for people with epilepsy, severe kidney impairment or an allergy to any of its ingredients11. It adds that prescribing information may differ from country to country11.

The maker’s dosing guide for health professionals, the source of the daily volumes above, lists the start of treatment as ‘as soon as possible’ for every use14. It is not consistent on brain injury: one version of its table gives a course of 7 to 30 days and another gives 3 to 30 days14.

Why doses are volumes, not milligrams

Cerebrolysin is a mixture of low-molecular-weight peptides and amino acids from pig brain, not one molecule10. A 2015 analysis of one sample bought online found 638 different peptides in it26. The maker states that each mL of the licensed solution contains 215.2 mg of Cerebrolysin concentrate11. Labels and trials give doses as volumes of this solution, and we do not convert them into weights.

Doses outside trials: a registry study and a guideline

C-REGS2, a maker-funded, open-label study in 16 countries that was not randomized, recorded how doctors used Cerebrolysin after moderate ischemic strokes from April 2018 to April 202425. Dose and length followed local practice; the median dose was 30 mL and the median course 10 days25. The 1,021 treated patients recovered better at 90 days than 748 controls (Mann-Whitney estimator 0.6157), with no differences in safety measures25. The authors note that, because the study was observational, differences between the groups that their analysis could not remove may remain, so it supports weaker conclusions about cause and effect than randomized trials25.

A 2021 guideline from the European Academy of Neurology and the European Federation of Neurorehabilitation Societies recommends Cerebrolysin at 30 mL a day into a vein for at least 10 days to support early rehabilitation after ischemic stroke27.

What reviews found about dose and harm

The table lists the largest published randomized trials we found, not all of them: Cochrane’s 2023 stroke review counted 7 trials with 1,773 people, including one of Cortexin, a similar product from cattle brain, and Cochrane’s 2019 vascular dementia review counted 6 trials with 597 people1028. Earlier studies used 10 to 50 mL a day for 10 to 30 days, the authors of the CARS stroke trial wrote19.

The stroke review found moderate-certainty evidence of an increase in non-fatal serious adverse events with Cerebrolysin (a risk ratio of 2.39, where 1 means no difference), and a larger increase in the 2 trials that gave 30 mL a day for 10 days, a cumulative 300 mL (risk ratio 2.87)10. It also notes that the maker supported three multicenter studies in the review, either fully or by supplying the drug and placebo, randomization codes, grants or statisticians10.

Questions people ask

How much Cerebrolysin should I take?

The maker’s guide for health professionals lists 20 to 50 mL a day after a stroke or brain injury and 10 to 30 mL a day for Alzheimer’s disease and other cognitive problems, and the largest stroke trial used 30 mL a day for 10 days1415. Cerebrolysin is prescription-only where it is licensed and is not approved in the US, and by our reading US pharmacies may not compound it11293031.

How many mL of Cerebrolysin is used for stroke?

The maker’s guide lists 20 to 50 mL a day for 10 to 21 days14. Trials used 30 mL a day for 10, 14 or 21 days, or 50 mL a day for 21 days, and a 2021 European guideline recommends 30 mL a day for at least 10 days in early rehabilitation16151927.

How long is a course of Cerebrolysin?

In the maker’s guide, a course lasts 10 to 21 days after a stroke and 7 to 30 days after a brain injury; for Alzheimer’s disease and other cognitive problems, one cycle is 5 days a week for 4 weeks, with 2 to 4 cycles a year14. CASTA treated for 10 days and CARS for 21, while three Alzheimer’s trials gave 4-week courses, two of them repeated after a 2-month break3451519.

Is a higher dose of Cerebrolysin better?

Not in a 24-week Alzheimer’s trial that compared three doses: all three improved the overall clinical impression, but only 10 mL improved thinking scores17. In healthy men given up to 50 mL, mild signs of overdose appeared at the highest doses21.

Go deeper

Sources

  1. 1Cerebrolysin as an Early Add-on to Reperfusion Therapy: Risk of Hemorrhagic Transformation after Ischemic Stroke (CEREHETIS), a prospective, randomized, multicenter pilot study BMC Neurology, 27 Mar 2023. pubmed.ncbi.nlm.nih.gov
  2. 2Combination treatment in Alzheimer’s disease: results of a randomized, controlled trial with cerebrolysin and donepezil Current Alzheimer Research, Aug 2011. pubmed.ncbi.nlm.nih.gov
  3. 3A Randomized, Double-Blind, Clinical Trial to Compare the Safety and Efficacy of Cerebrolysin and Aricept (Donepezil) and a Combination Therapy in Patients With Probable Alzheimer’s Disease (NCT00911807) ClinicalTrials.gov, accessed 7 Oct 2026. clinicaltrials.gov
  4. 4Cerebrolysin in Alzheimer’s disease: a randomized, double-blind, placebo-controlled trial with a neurotrophic agent Journal of Neural Transmission, Jul 2002. pubmed.ncbi.nlm.nih.gov
  5. 5A 28-week, double-blind, placebo-controlled study with Cerebrolysin in patients with mild to moderate Alzheimer’s disease International Clinical Psychopharmacology, Sep 2001. pubmed.ncbi.nlm.nih.gov
  6. 6Neuroprotective treatment with cerebrolysin in patients with acute stroke: a randomised controlled trial Journal of Neural Transmission, Mar 2005. pubmed.ncbi.nlm.nih.gov
  7. 7A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke International Journal of Stroke, Feb 2013. pubmed.ncbi.nlm.nih.gov
  8. 8Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial Neurological Sciences, Feb 2020. pubmed.ncbi.nlm.nih.gov
  9. 9The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery (NCT01606111) ClinicalTrials.gov, accessed 7 Oct 2026. clinicaltrials.gov
  10. 10Cerebrolysin for acute ischaemic stroke Cochrane Database of Systematic Reviews, 11 Oct 2023. pubmed.ncbi.nlm.nih.gov
  11. 11About Cerebrolysin (product page with prescribing information and notice to U.S. visitors) EVER Neuro Pharma GmbH (maker of Cerebrolysin), 25 Jan 2024. cerebrolysin.com
  12. 12Article 57 product data (EMA/518502/2018, Rev.89; data as present in the Article 57 database on 21 September 2026) European Medicines Agency, 21 Sep 2026. ema.europa.eu
  13. 13Life-Threatening Anaphylaxis due to Cerebrolysin® Case Reports in Neurological Medicine, 2024. pmc.ncbi.nlm.nih.gov
  14. 14How to use Cerebrolysin: step-by-step guide (for health professionals) EVER Neuro Pharma GmbH (maker of Cerebrolysin), 4 Sep 2024. cerebrolysin.com
  15. 15Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial Stroke, Mar 2012. pubmed.ncbi.nlm.nih.gov
  16. 16Cerebrolysin in Patients With Acute Ischemic Stroke in Asia (CASTA), NCT00868283 ClinicalTrials.gov, U.S. National Library of Medicine, accessed 7 Oct 2026. clinicaltrials.gov
  17. 17A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer’s disease European Journal of Neurology, Jan 2006. pubmed.ncbi.nlm.nih.gov
  18. 18Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial Journal of Stroke and Cerebrovascular Diseases, Jul 2011. pubmed.ncbi.nlm.nih.gov
  19. 19Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial Stroke, Jan 2016. pmc.ncbi.nlm.nih.gov
  20. 20Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial Neurological Sciences, May 2020. pubmed.ncbi.nlm.nih.gov
  21. 21Dose-dependent effects of Cerebrolysin on EEG and short-term memory of healthy volunteers during control and hyperventilation induced cerebral ischemia Journal of Neural Transmission. Supplementum, 1998. pubmed.ncbi.nlm.nih.gov
  22. 22Cerebroprotein Hydrolysate (product page, which carries the seller’s earlier Cerebrolysin reviews) CosmicNootropic (vendor), 6 Oct 2026. cosmicnootropic.com (seller page, deliberately not linked)
  23. 23Cerebrolysin dose-dependently improves neurological outcome in rats after acute stroke: A prospective, randomized, blinded, and placebo-controlled study International Journal of Stroke, Apr 2016. pubmed.ncbi.nlm.nih.gov
  24. 24Neuroprotective action of Cortexin, Cerebrolysin and Actovegin in acute or chronic brain ischemia in rats PLoS One, 2021. pubmed.ncbi.nlm.nih.gov
  25. 25C-REGS2-A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke International Journal of Stroke, Oct 2025. pmc.ncbi.nlm.nih.gov
  26. 26Peptide 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 Testing and Analysis, Sep 2015. pubmed.ncbi.nlm.nih.gov
  27. 27European Academy of Neurology and European Federation of Neurorehabilitation Societies guideline on pharmacological support in early motor rehabilitation after acute ischaemic stroke European Journal of Neurology, Sep 2021. pubmed.ncbi.nlm.nih.gov
  28. 28Cerebrolysin for vascular dementia Cochrane Database of Systematic Reviews, 11 Nov 2019. pubmed.ncbi.nlm.nih.gov
  29. 29Warning letter to Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine (MARCS-CMS 615908) U.S. Food and Drug Administration, 10 Nov 2021. fda.gov
  30. 30Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 14 May 2026. fda.gov
  31. 31Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 21 Mar 2025. fda.gov

Not medical advice. Talk to a licensed clinician before using any drug. Report an error.