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Peptide mixtureHuman trialsNot FDA approved

Cerebrolysin

Cerebrolysin

Last reviewed October 27, 2026 · 23 sources · Written for general readers · Compare with another compound →

The bottom line

Cerebrolysin has been tested in more people than most peptides, and the results are disappointing for its main use. The largest stroke trial found no benefit, and the best summary of stroke trials found it probably does not change the chance of dying and may raise some serious side effects. Smaller trials in dementia, brain injury, stroke rehab and other conditions look more positive but are weaker, often open label or industry funded. It is not approved in the United States.

Where the evidence stands

What it is

Cerebrolysin is a mixture of small peptides and amino acids taken from pig brain tissue.[1] Because it is a mixture, it has no single chemical formula or sequence.

It is widely used for stroke in Russia, Eastern Europe, China and other parts of Asia.[1] In trials it was given as an IV drip, or in some studies as an injection into the muscle.[2][3][4] It is not an approved drug in the United States, and there is no US drug label for it.[5]

Name
Cerebrolysin (Cerebrolysin)
Type
Peptide mixture

What it does in the body

Cerebrolysin is not a single natural molecule. It is a pig brain extract of small peptides and amino acids, and researchers think it acts somewhat like the brain's own growth factors that protect and repair nerve cells, but the active parts are not clear.[1]

This is the biology, area by area. A change measured in the body, like a higher blood level, does not always mean a person feels a benefit. The claims check below covers that.

Brain after a stroke

Measured in people

In people, measured effects on stroke are small. A 2025 pooled analysis of 14 placebo controlled trials with 2,884 patients found stroke severity scores improved by about 1.4 points more with Cerebrolysin, but there was no clear change in the share who became independent or in deaths.[6] The largest single trial, CASTA, found no difference at 90 days.[2]

Bleeding in the brain

Measured in people

The same pooled analysis found bleeding into the stroke area about 45% less common with Cerebrolysin.[6] In an open study of 50 people treated after clot removal, brain bleeding occurred in 14% versus 40% of matched past patients.[7] These are small or nonrandomized signals.

Alzheimer's proteins

Measured in people

In a randomized trial of 110 people with Alzheimer's disease, Cerebrolysin lowered several forms of tau in tiny nerve derived particles in the blood more than donepezil, a standard Alzheimer's drug, and the two together lowered amyloid more than either alone. Two authors worked for the maker.[8]

Nerve repair

Seen in animals

In rats after a stroke, it improved movement recovery when started 1 or 2 days later, but did not shrink the damaged area.[9] It boosted the growth of new brain cells, and blocking the Sonic hedgehog repair signal erased that benefit.[10]

Nerves and muscles

Measured in people

In a placebo controlled trial of 20 people with ALS, a disease that destroys the nerves that move muscles, function scores rose about 2.3 points with Cerebrolysin over the first month and fell about 0.9 points with placebo, and the difference lasted 3 months. One author had a grant from the maker.[11]

Smell and taste

Measured in people

In a randomized trial of 250 adults with smell and taste loss lasting months after COVID-19, about 62% of the analyzed patients given Cerebrolysin injections plus smell training recovered fully. The authors reported no recovery with training alone, and there was no placebo.[4]

Developing brain

Measured in people

In a randomized trial in high risk babies born before 32 weeks, 33% of those given Cerebrolysin failed a gross motor test at 12 months of corrected age, versus 70% with early therapy alone. The trial was small and not described as placebo controlled.[12]

How it works

Researchers think it may protect nerve cells, but because it is a mixture, the active parts are not clear.[1]

  • In rats after a stroke, it boosted the growth of new brain cells through a repair signal called Sonic hedgehog.[10]
  • In rats, it improved movement recovery without shrinking the damaged brain area, which suggests it works on repair more than on protection.[9]
  • In people with Alzheimer's disease, it changed tau and amyloid levels in nerve derived particles in the blood.[8]

The repair mechanism comes from animal work. The blood marker changes in people have not been shown to predict better outcomes.

What the research shows

We keep animal and human evidence apart. A result in animals is a reason to study something in people, not proof that it works in people.

Animal and lab studies

Recovery signals in rat stroke models

  • In rats, it improved movement recovery when started 1 or 2 days after a stroke, but not at 3 days.[9]
  • It did not shrink the damaged brain area in that study.[9]
  • It boosted new brain cell growth, and blocking the Sonic hedgehog signal erased its recovery benefit in rats.[10]

Limit: Rat stroke models have a poor record of predicting results in people.

Human studies

Many trials, but no proven benefit for stroke survival

  • A 2023 Cochrane review, a highly trusted type of trial summary, pooled 7 randomized trials with 1,773 people who had an acute stroke. With moderate certainty, it found no change in the chance of dying, and nonfatal serious side effects were about 2.4 times as common with Cerebrolysin.[1]
  • In CASTA, 1,070 people in Asia got an IV drip of Cerebrolysin or saline for 10 days, starting within 12 hours of stroke. At 90 days the main combined recovery score did not differ. A possible benefit in the most severe strokes needed confirmation.[2]
  • A 2025 pooled analysis of 14 placebo controlled stroke trials with 2,884 patients found a small gain in stroke severity scores, no clear change in independence or deaths, similar serious side effects, and less bleeding into the stroke area.[6]
  • In CARS, people got an IV drip or saline for 21 days along with rehab. Arm function was better at 90 days, but the authors called the trial small and exploratory.[3]
  • A 2021 review of 12 placebo controlled trials with about 2,200 stroke patients found no difference in serious side effects compared with placebo.[13]
  • In the ESCAS pilot, 123 people with speech loss after stroke got Cerebrolysin or placebo along with speech therapy. Language scores rose about 15 points more with Cerebrolysin by day 90.[14]
  • After clot removal for a major stroke, an open single center study of 50 people found 68% were largely independent at 90 days, versus 44% of 50 matched past patients. This was not a randomized comparison.[7]
  • In two pooled trials of 185 people with moderate to severe traumatic brain injury, IV Cerebrolysin gave a small to moderate edge on recovery scores at 30 and 90 days, with similar safety.[15] A 2023 review of 10 mostly observational brain injury studies with 8,749 patients found better coma and recovery scores but no change in deaths or hospital stay.[16]
  • A 2023 review of studies in bleeding around the brain from a burst blood vessel reported fewer deaths with Cerebrolysin, but the authors called for larger randomized trials.[17]
  • A 2019 Cochrane review of 6 trials with 597 people with vascular dementia, memory loss from blood vessel damage, found small gains but called the evidence very low quality.[18] A review of 6 trials in mild to moderate Alzheimer's disease found thinking scores better at 4 weeks but not significantly at 6 months.[19]
  • In a Russian study of 100 older adults with mild memory loss, randomly split into two groups and followed for 3 years, fewer of those given Cerebrolysin by IV drip progressed to dementia. The design was open, with no placebo.[20]
  • Smaller trials outside the brain injury field reported benefits in 20 people with ALS (placebo controlled), in 250 adults with lasting smell loss after COVID-19 (randomized, no placebo), and in high risk preterm babies (not placebo controlled).[11][4][12]

Limit: Many trials had an unclear risk of bias, many newer positive studies are small, open label or observational, and the maker supported several of the larger trials.[1]

Claims check

The most common claims about this compound, and what studies actually found. Verdicts rate the evidence, not whether you should use it.

Speeds recovery after stroke

Mixed results

The largest trial, CASTA, gave 1,070 people in Asia an IV drip or placebo for 10 days after stroke and found no difference at 90 days.[2] A smaller trial paired with rehab, CARS, reported better arm function at 90 days, though its authors called it exploratory.[3] A 2023 Cochrane review of 7 trials found no change in deaths, and a 2025 analysis of 14 trials found only a small gain in severity scores.[1][6]

Improves memory in dementia

Mixed results

A 2019 Cochrane review of 6 trials with 597 people with vascular dementia found small gains in thinking scores, but called the evidence very low quality.[18] A review of 6 Alzheimer's trials found thinking scores better after 4 weeks but not significantly better at 6 months.[19] An earlier review found overall impressions improved but judged the evidence on thinking and daily living insufficient.[21]

Prevents dementia in people with mild memory loss

Mixed results

One open Russian study of 100 older adults followed for 3 years reported fewer conversions to dementia with Cerebrolysin, but it had no placebo and gave no numbers in its summary.[20] No blinded trial has confirmed this.

Helps recovery after brain injury

Mixed results

Two placebo controlled trials in 185 people with moderate to severe traumatic brain injury, pooled together, found a small to moderate benefit on combined recovery scores at 30 and 90 days, with similar safety to placebo.[15] A 2023 review of mostly observational studies found better coma and recovery scores but no change in deaths.[16] No large independent trial has confirmed this.

Helps speech come back after stroke

Mixed results

In a pilot of 123 people with speech loss after stroke, those given Cerebrolysin plus speech therapy gained about 36 points on a language test by day 90, compared with about 21 points on placebo plus speech therapy.[14] This is one small trial that needs repeating.

Boosts focus and memory in healthy people

Not tested

Every trial we found enrolled people with stroke, dementia, brain injury or other illness.[1][18][15] No study has tested it as a brain booster in healthy people.

Protects and regrows brain cells

Only in animals

In rats after a stroke, it helped movement recovery and boosted new brain cell growth, but it did not shrink the damaged area.[9][10] Human trials have not shown this translates into better survival.[1]

Known risks and side effects

  • Possible serious side effects. The Cochrane review found nonfatal serious adverse events about 2.4 times as often in people given Cerebrolysin, with moderate certainty.[1] Other pooled analyses found serious side effects similar to placebo, so the true risk is uncertain.[13][6]
  • No proven benefit for survival. For stroke, the best evidence shows no effect on survival, so people take on risk without a clear payoff.[1]
  • Unregulated imports. With no US approval or label, any product bought online has not been checked by FDA for quality or authenticity.[5]
  • Research funding bias. The maker supported several large trials, and most studies had an unclear risk of bias.[1] Three of the six vascular dementia trials were industry funded.[18] Maker staff or grants also appear in some newer positive studies.[8][11]

Regulatory status

Today: Cerebrolysin is not approved by FDA, and no US drug label exists.[5] It is used as a medicine in other countries, including Russia and China.[1] The 2026 and 2027 WADA lists do not name it.[22][23]

Sources

  1. Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023;10(10):CD007026. PMID 37818733
  2. Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z; CASTA Investigators. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial. Stroke. 2012;43(3):630-636. PMID 22282884
  3. Muresanu DF, Heiss WD, Hoemberg V, Bajenaru O, Popescu CD, Vester JC, et al. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016;47(1):151-159. PMID 26564102
  4. Hamed SA, Ahmed MAA. The effectiveness of cerebrolysin, a multi-modal neurotrophic factor, for treatment of post-covid-19 persistent olfactory, gustatory and trigeminal chemosensory dysfunctions: a randomized clinical trial. Expert Rev Clin Pharmacol. 2023;16(12):1261-1276. PMID 37950370
  5. DailyMed. Search results for cerebrolysin. U.S. National Library of Medicine. Searched October 2026; 0 results. DailyMed
  6. Patel PN, Mangal D, Patel K. Safety and Efficacy of Cerebrolysin for Neurorecovery After Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of 14 Randomized Controlled Trials. Cureus. 2025;17(8):e91054. PMID 41018475
  7. Staszewski J, Dębiec A, Strilciuc S, Gniadek-Olejniczak K, Piusinska-Macoch R, Balo D, et al. Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion in Anterior Circulation: Results of a 3-Month Follow-up of a Prospective, Open Label, Single-Center Study. Transl Stroke Res. 2025;16(6):1931-1946. PMID 40325343
  8. Alvarez XA, Winston CN, Barlow JW, Sarsoza FM, Alvarez I, Aleixandre M, et al. Modulation of Amyloid-β and Tau in Alzheimer's Disease Plasma Neuronal-Derived Extracellular Vesicles by Cerebrolysin® and Donepezil. J Alzheimers Dis. 2022;90(2):705-717. PMID 36155516
  9. Ren J, Sietsma D, Qiu S, Moessler H, Finklestein SP. Cerebrolysin enhances functional recovery following focal cerebral infarction in rats. Restor Neurol Neurosci. 2007;25(1):25-31. PMID 17473393
  10. Zhang L, Chopp M, Meier DH, et al. Sonic hedgehog signaling pathway mediates cerebrolysin-improved neurological function after stroke. Stroke. 2013;44(7):1965-1972. PMID 23696546
  11. Firstenfeld AJ, Listorti J, Jalaff N, Loaiza Orozco CP, Navarrete Gosdenovich F, Schurr T, et al. Add-on treatment with Cerebrolysin improves clinical symptoms in patients with ALS: results from a prospective, single-center, placebo-controlled, randomized, double-blind, phase II study. J Med Life. 2023;16(12):1750-1755. PMID 38585517
  12. Samir A, Nasef N, Fathy K, El-Gilany AH, Yahia S. Effect of cerebrolysin on neurodevelopmental outcome of high risk preterm infants: A randomized controlled trial. J Neonatal Perinatal Med. 2022;15(1):37-45. PMID 33935111
  13. Strilciuc S, Vécsei L, Boering D, Pražnikar A, Kaut O, Riederer P, Battistin L. 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. PMID 34959697
  14. Homberg V, Jianu DC, Stan A, Strilciuc Ș, Chelaru VF, Karliński M, et al. Speech Therapy Combined With Cerebrolysin in Enhancing Nonfluent Aphasia Recovery After Acute Ischemic Stroke: ESCAS Randomized Pilot Study. Stroke. 2025;56(4):937-947. PMID 39957612
  15. Vester JC, Buzoianu AD, Florian SI, Hömberg V, Kim SH, Lee TMC, 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. PMID 33620612
  16. Jarosz K, Kojder K, Andrzejewska A, Solek-Pastuszka J, Jurczak A. Cerebrolysin in Patients with TBI: Systematic Review and Meta-Analysis. Brain Sci. 2023;13(3):507. PMID 36979317
  17. Kojder K, Jarosz K, Bosiacki M, Andrzejewska A, Zacha S, Solek-Pastuszka J, et al. Cerebrolysin in Patients with Subarachnoid Hemorrhage: A Systematic Review and Meta-Analysis. J Clin Med. 2023;12(20):6638. PMID 37892776
  18. Cui S, Chen N, Yang M, Guo J, Zhou M, Zhu C, He L. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019;2019(11):CD008900. PMID 31710397
  19. Gauthier S, Proaño JV, Jia J, Froelich L, Vester JC, Doppler E. 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. PMID 25832905
  20. Ponomareva EV, Androsova LV, Krynskiy SA, Gavrilova SI. [Cerebrolysin in the preventive therapy of dementia in elderly patients with mild cognitive impairment: a three-year prospective comparative study]. Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(9):51-59. PMID 39435777
  21. Wei ZH, He QB, Wang H, Su BH, Chen HZ. Meta-analysis: the efficacy of nootropic agent Cerebrolysin in the treatment of Alzheimer's disease. J Neural Transm (Vienna). 2007;114(5):629-634. PMID 17318304
  22. World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2026. In force January 1, 2026. WADA 2026 List
  23. World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2027. Approved September 10, 2026; in force January 1, 2027. WADA 2027 List
Medical disclaimer

This page is educational information only. It is not medical advice and does not replace care from a licensed medical provider. Do not use this page to decide whether to take any substance. Talk to a licensed medical provider first.

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