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Injury & recovery · IV drip

Cerebrolysin

Gray market

Checked · 26 sources · 14 corrections on this page · No vendors · No affiliates · No one buys a word of it

Better arm function at 90 days

Moderate Evidence · a 1,070-patient trial was neutral · CARS-1, 208 patients · Muresanu 2016

Gray market · No FDA ruling — not on any list

Sold as a research chemical. Some clinics and pharmacies still supply it; that’s their risk, not a change in the rule.

Bottom line

Positive results on rating scales in mostly manufacturer-linked trials, and, per the independent Cochrane review, probably no effect on death after stroke and more non-fatal serious adverse events (Ziganshina et al., 2023).

Also called
  • Cerebrolysin Concentrate
  • FPF-1070
  • Cere
  • porcine brain peptide hydrolysate (Ever Neuro Pharma)
Category
Peptide — Neurotrophic Brain Bioregulator
Class
Brain peptide hydrolysate
Composition
~25% peptides <10 kDa
~75% free amino acids
Source
Porcine brain (enzymatic)
Route (studied)
IM, IV (people)
Route (sold)
IV/IM ampoules (Rx ex-US; research chemical in the US)
FDA Status
Not approved (US)
EMA Status
Not approved (EU)
Ex-US Approvals
Prescription medicine in Austria and Russia
Clinical Trials
90 in PubMed (62 randomized), searched October 4, 2026
WADA Status
Not specifically named; approved as a medicine in Russia and other countries, so S0 does not apply
Cost & Access
Research-only

Also for injury & recovery

The other four questions

What does it do? It is a mixture of small peptides and amino acids from pig brain (Ziganshina et al., 2023), described in reviews as acting like the brain’s own growth factors (Brainin et al., 2018; Rejdak et al., 2023); in Alzheimer’s mice it cut amyloid and preserved synapses (Rockenstein et al., 2003).
Who uses it? Stroke and dementia clinics in Russia, Eastern Europe, China and elsewhere in Asia (Ziganshina et al., 2023; Cui et al., 2019), giving it by IV infusion or injection (EVER Pharma prescribing information).
Does the evidence hold up? Mixed. A 208-patient stroke-rehabilitation trial found better arm function at 90 days (Muresanu et al., 2016); a 1,070-patient acute-stroke trial was neutral (Heiss et al., 2012); the brain-injury trials found a small-to-medium benefit (Vester et al., 2021). The independent 2023 Cochrane review found it probably makes little or no difference to death after stroke, and noted that the manufacturer supported three of its trials (Ziganshina et al., 2023).
Bottom line? Positive results on rating scales in mostly manufacturer-linked trials, and, per the independent Cochrane review, probably no effect on death after stroke and more non-fatal serious adverse events (Ziganshina et al., 2023).

Dosing from the Literature

Published for stroke recovery: 30 mL a day by IV infusion for 10–21 days, from the major trials. Not published: any dose outside a clinic.

Cerebrolysin is a clinic-administered parenteral preparation. The following dosing summarizes the regimens used in the major trials. It is not a self-administration guide, and Cerebrolysin is not legally available from U.S. compounding pharmacies.

Indication / TrialDoseRouteDuration
Acute ischemic stroke (CASTA)30 mL/dayIV infusion, with aspirin 100 mg a day10 days, from within 12 hours of onset; 1,070 patients (Heiss et al., 2012)
Early stroke rehabilitation (CARS)30 mL/dayIV infusion, with a 21-day rehabilitation program21 days, from 24–72 hours after onset; 208 patients (Muresanu et al., 2016)
Early stroke recovery (Gharagozli)30 mL/day for 7 days, then 10 mL/dayIVTo day 30; 100 patients, from within 18 hours of onset (Gharagozli et al., 2017)
EAN/EFNR guideline, early rehabilitation after stroke30 mL/dayIVAt least 10 days (Beghi et al., 2021)
Moderate-severe TBI (CAPTAIN I/II)50 mL/day for 10 days, then 10 mL/dayIVTwo more 10-day cycles of 10 mL/day; 46 and 142 patients (Poon et al., 2020; Muresanu et al., 2020)
Vascular and Alzheimer’s dementia (manufacturer)10–30 mL/dayIVCycles of 5 days a week for 4 weeks, 2–4 cycles a year (EVER Pharma prescribing information); the Alzheimer’s trials in the meta-analysis used 30 mL/day (Gauthier et al., 2015)
Infants with perinatal brain injury0.1 mL/kgInjectionTwice a week for 5 weeks, ten injections; 158 infants with communication defects (Hassanein et al., 2016)
Subarachnoid hemorrhage (Woo pilot)30 mL/dayIV14 days; 50 patients (Woo et al., 2020)
Dosing Disclaimer

The doses above are those of the trials, a European guideline and the manufacturer’s prescribing information, given in hospitals and clinics in countries where Cerebrolysin is approved. It is not approved in the United States. Consult a licensed healthcare provider.

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What It Is

Cerebrolysin is a parenteral preparation of low-molecular-weight peptides and free amino acids produced by controlled enzymatic breakdown (pancreatic hydrolysis) of porcine brain tissue. Roughly 25% of the final product by weight consists of biologically active peptide fragments under 10 kilodaltons in molecular weight; the remaining 75% is free amino acids. It is manufactured by Ever Neuro Pharma in Austria and has been in continuous clinical use since the 1970s.

The product is formulated as a clear, sterile, slightly amber-colored aqueous solution supplied in 1 mL, 5 mL, 10 mL, 20 mL, and 30 mL ampoules at a concentration equivalent to 215.2 mg of peptide hydrolysate per 1 mL. It is administered exclusively as an intravenous infusion (diluted in saline or Ringer's solution) or intramuscular injection. The formulation is not stable for oral delivery — gastric proteases would degrade the peptide fraction within minutes of ingestion, and oral bioavailability has never been claimed.

Cerebrolysin is a prescription medicine in Austria, where its maker, EVER Neuro Pharma, holds the marketing authorisation, and in Russia (EVER Neuro Pharma prescribing information; RLS, 2026). It is not approved by the U.S. Food and Drug Administration (EVER Neuro Pharma). The maker’s prescribing information lists cerebrovascular disorders, especially Alzheimer’s-type dementia, vascular dementia, stroke and head injury.

Cerebrolysin's clinical research base is unusually large for a non-FDA-approved compound. PubMed indexes 90 records typed as clinical trials, 62 of them randomized controlled trials (searched October 4, 2026), including several multicenter placebo-controlled studies. Independent reviewers have flagged industry support: in the 2023 Cochrane stroke review the manufacturer supported three of the multicentre trials (Ziganshina et al., 2023), and in the 2019 vascular-dementia review every trial that reported its funding was industry-supported (Cui et al., 2019).

Mechanism of Action

Cerebrolysin is a multimodal compound — its biological activity reflects the combined effects of dozens of low-molecular-weight peptide fragments engaging multiple neurotrophic and neuroprotective pathways simultaneously. There is no single receptor target. The mechanistic literature, drawn primarily from preclinical models, attributes the following effects to the peptide fraction:

  • Neurotrophic factor mimicry — The peptide fraction engages signaling pathways overlapping with nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), glial-derived neurotrophic factor (GDNF), and ciliary neurotrophic factor (CNTF). Cerebrolysin upregulates downstream effectors of these pathways including TrkA (the nerve-growth-factor receptor on neurons), TrkB (BDNF's receptor — how brain growth signals reach neurons), and PI3K-Akt, supporting neuronal survival, axon outgrowth, and synaptic remodeling. This neurotrophic mimicry is the central pharmacological claim of the compound (Brainin, 2018; Rejdak, 2023).
  • Amyloid metabolism modulation — In transgenic Alzheimer's mice, Cerebrolysin reduced amyloid-β burden (by 43% in the younger group and 27% in the older), preserved synapses, and improved water-maze performance in the younger group — providing a mechanistic basis for the Alzheimer's clinical-trial program (Rockenstein et al., 2003).
  • A mixture, not one molecule — Cerebrolysin is low-molecular-weight peptides and amino acids from enzymatically broken-down pig brain protein (Ladurner et al., 2005; Ziganshina et al., 2023), and its developers call it a multi-target drug (Brainin et al., 2018); no single active component is named in the sources read.

What the Research Shows

Cerebrolysin's clinical evidence base spans four major indications — ischemic stroke, traumatic brain injury, vascular dementia, and Alzheimer's-type dementia — plus smaller pediatric and miscellaneous trial programs. The signal is mixed: mostly positive on patient-reported and clinician-rated outcome scales, neutral in some trials; the independent 2023 Cochrane stroke review found probably no effect on all-cause death.

  • Ischemic stroke — CARS-1 and CARS-2 trials — The 2016 CARS-1 trial (Muresanu et al., Stroke; PMID 26564102) randomized 208 patients to 30 mL Cerebrolysin or placebo daily for 21 days during early post-stroke rehabilitation. The combined ARAT-day-90 endpoint indicated motor superiority for Cerebrolysin (Mann-Whitney 0.62, p<0.0001 in the pooled CARS-1/CARS-2 analysis), with NIHSS improvements at days 14 and 21 and a number-needed-to-treat (NNT) of approximately 7.1 for clinically relevant change.
  • Ischemic stroke — CASTA Asian trial — The 2012 CASTA trial (Heiss, Brainin, Bornstein, Tuomilehto, Hong et al., Stroke; PMID 22282884) was the largest acute-phase Cerebrolysin stroke trial, randomizing patients within 12 hours of symptom onset across multiple Asian countries. The confirmatory endpoint was neutral, but a pre-specified subgroup (severe NIHSS >12) showed a favorable outcome trend — a result that has shaped the field's framing of Cerebrolysin as a higher-value intervention in more severe strokes.
  • Stroke meta-analysis — The 2018 Bornstein meta-analysis of nine RCTs (PMID 29248999) combined 1,879 patients and reported NIHSS-30 superiority for Cerebrolysin (Mann-Whitney 0.60, p<0.0001), with combined NNT of 7.7 for clinically relevant change.
  • Stroke Cochrane review — The 2023 update by Ziganshina et al. (Cochrane Database Syst Rev; PMID 37818733) judged moderate-certainty evidence indicating Cerebrolysin probably has no beneficial effect on preventing all-cause death after acute ischemic stroke, and a possible increase in non-fatal serious adverse events; none of the included trials reported death or dependence as an outcome. The Cochrane verdict is the most rigorously methodologically conservative independent assessment available; it differs from the sponsor-pooled meta-analyses primarily by emphasizing methodological quality and risk-of-bias judgment over effect-size pooling.
  • Traumatic brain injury — CAPTAIN I and II — The CAPTAIN I trial (Poon et al., Neurol Sci 2019; PMID 31494820) and CAPTAIN II trial (Muresanu et al., Neurol Sci 2020; PMID 31897941) evaluated Cerebrolysin in 46 and 142 patients respectively after moderate-to-severe TBI. Both used a multidimensional 13-scale outcome ensemble and reported "small-to-medium" effect sizes favoring Cerebrolysin, with statistical significance at day 90 for the multivariate ensemble (CAPTAIN II: MW 0.59, p=0.0119). The 2021 prospective meta-analysis of the two trials (PMID 33620612) confirmed small-to-medium effect at days 30 and 90.
  • Vascular dementia — Cochrane review — The 2019 Cochrane review by Cui et al. (PMID 31710397) included six RCTs (597 participants) and reported beneficial effects on cognitive function (standardized mean difference 0.36) and global outcome, but rated the evidence very low quality: heterogeneity, high risk of bias, and effects that may be too small to matter clinically. Conclusion: insufficient evidence to recommend Cerebrolysin as routine treatment for vascular dementia, although a clinically meaningful signal exists.
  • Alzheimer's disease meta-analysis — The 2015 meta-analysis (Gauthier et al., Dement Geriatr Cogn Disord; PMID 25832905) of randomized double-blind placebo-controlled trials reported Cerebrolysin superiority on cognitive function at 4 weeks (SMD −0.40; p=0.0031), global clinical change (OR 3.32 at 4 weeks; OR 4.98 at 6 months), and the combined "global benefit" endpoint at both timepoints. Effect sizes are modest but consistent.
  • Subarachnoid hemorrhage pilot — Woo et al., BMC Neurol 2020 (PMID 33143640) — a randomized placebo-controlled pilot in 50 patients with aneurysmal SAH found it safe and well tolerated, with no improvement in six-month functional outcome, cognition or delayed cerebral ischemia.
  • Aphasia adjunct — Jianu et al., J Med Life 2010 (PMID 20945821) — Cerebrolysin as adjunct in Broca's aphasia after left middle cerebral artery stroke, reporting language-recovery improvement on standardized aphasia scales.
  • Pediatric perinatal brain injury — Hassanein et al., J Clin Neurol 2016 (PMID 26365023) — randomized controlled trial in infants with communication defects from severe perinatal brain insult, reporting language-development improvement on Cerebrolysin compared with controls.
Critical Context — Sponsorship and Independent Review

The overwhelming majority of Cerebrolysin clinical trials and meta-analyses involve authors with disclosed financial relationships to Ever Neuro Pharma — speaker fees, grant support, advisory roles, or direct employment. The Cochrane independent reviews (Cui 2019 vascular dementia; Ziganshina 2023 stroke) are the most methodologically conservative independent assessments and consistently arrive at more cautious conclusions than the sponsor-affiliated meta-analyses. This is the single most important context for interpreting any positive Cerebrolysin headline. Real signal probably exists in early stroke recovery and TBI rehabilitation, but the magnitude is likely smaller than sponsor-pooled effect sizes suggest.

Human Data

Unlike most peptides on this site, Cerebrolysin's primary evidence base is human data. PubMed lists 90 clinical-trial records across stroke, TBI, dementia and pediatric indications (searched October 4, 2026). Selected pivotal and confirmatory studies:

  • CARS-1 (PMID 26564102) — 208 patients; 30 mL Cerebrolysin daily for 21 days during early post-stroke rehabilitation. Primary endpoint: ARAT motor function at day 90, in Cerebrolysin's favor (Mann-Whitney 0.71, p<0.0001); global status across 12 scales, Mann-Whitney 0.62. The authors call the trial exploratory and small.
  • CASTA (PMID 22282884) — 1,070 patients across Asian sites; 30 mL Cerebrolysin daily for 10 days within 12 hours of acute ischemic stroke onset. Confirmatory endpoint neutral; a post hoc analysis of the severe-stroke subgroup (NIHSS >12) showed a favorable outcome trend.
  • Bornstein 2018 nine-trial meta-analysis (PMID 29248999) — 1,879 patients pooled across nine acute and early-recovery stroke RCTs. NIHSS day 30 Mann-Whitney 0.60, p<0.0001; combined NNT 7.7 for clinically relevant change.
  • Gharagozli 2017 (PMID 29075343) — Iranian multicenter RCT, 30 mL Cerebrolysin daily for 7 days then 10 mL daily through day 30. Cerebrolysin superior on NIHSS day 30 (MW 0.66; p=0.005), modified Rankin Scale (MW 0.65; p=0.010), and Clinical Global Impression (MW 0.70; p=0.006).
  • CAPTAIN I (PMID 31494820) — 46 patients with moderate-severe TBI; multidimensional outcome ensemble. Stand-alone significance on Stroop, Color Trails 1 and 2; ITT primary multivariate ensemble missed significance at p<0.1.
  • CAPTAIN II (PMID 31897941) — 142 patients with moderate-severe TBI; multidimensional 13-scale ensemble. Statistically significant at day 90 (MW 0.59, p=0.0119).
  • CAPTAIN meta-analysis (PMID 33620612) — Combined CAPTAIN I + II (185 patients). Small-to-medium effect favoring Cerebrolysin at days 30 and 90.
  • Vascular dementia Cochrane (PMID 31710397) — Six RCTs, 597 participants. Beneficial effect on cognitive function (standardized mean difference 0.36) and global outcome; rated very low quality.
  • Mild-to-moderate Alzheimer's meta-analysis (PMID 25832905) — Cognitive function SMD −0.40 at 4 weeks; global clinical change OR 3.32 at 4 weeks, OR 4.98 at 6 months.
  • SAH pilot (PMID 33143640) — Randomized placebo-controlled pilot in aneurysmal subarachnoid hemorrhage (50 patients); safe, with no improvement in six-month outcome.

The 2023 Cochrane stroke review (PMID 37818733) is the single most rigorous independent appraisal: moderate-certainty evidence that Cerebrolysin probably has no beneficial effect on preventing all-cause death in acute ischemic stroke, and a possible increase in non-fatal serious adverse events; none of its trials reported death or dependence. The discrepancy between sponsor-pooled meta-analyses (positive small-to-medium effect on rating scales) and Cochrane mortality conclusions (no benefit) reflects different methodological priorities, not a contradiction in the underlying data.

Reconstitution & Storage

Cerebrolysin is supplied as a sterile aqueous solution (no reconstitution required) in ampoules; one mL contains 215.2 mg of Cerebrolysin concentrate (EVER Pharma prescribing information).

Dose volumeCerebrolysin contentHow the manufacturer says it is givenUsed in
5 mL~1,076 mgIM or IV injection, undiluted, over 3 minutes—
10 mL~2,152 mgIV injection undiluted over 3 minutes, or IV infusion diluted to at least 100 mLGharagozli’s days 8–30; the CAPTAIN cycles
30 mL~6,456 mgIV infusion diluted to at least 100 mL, given within 15 minutesCARS, CASTA
50 mL~10,760 mgIV infusion diluted to at least 100 mL, given within 15 minutesCAPTAIN days 1–10
  • Compatibility — The manufacturer dilutes infusions with 0.9% saline, Ringer’s solution or 5% glucose, and says Cerebrolysin should not be mixed with balanced amino acid solutions, vitamins or cardiovascular medicines (EVER Pharma prescribing information).
  • Storage — Not above 25 °C, not frozen, protected from light in the carton; an ampoule is used immediately after opening (EVER Pharma prescribing information).

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Side Effects & Risks

Important

Cerebrolysin is given by IV or IM injection, and its prescribing information lists epilepsy, severe renal impairment and hypersensitivity to its components as contraindications (EVER Pharma prescribing information). It is not approved in the United States. Consult a licensed healthcare provider.

In the 2023 Cochrane review of stroke trials, serious adverse events overall were about as common on Cerebrolysin as on placebo, but non-fatal serious adverse events were more common (risk ratio 2.39; 3 trials, 1,335 people), most of all at 30 mL a day for 10 days (Ziganshina et al., 2023).

  • Adverse events overall — In the stroke trials, about as many people had an adverse event as on placebo (Ziganshina et al., 2023); in the vascular-dementia trials, only non-serious adverse events occurred, no more often than on placebo (Chen et al., 2013); in the CARS trial, safety was comparable with placebo (Muresanu et al., 2016).
  • Hypersensitivity — Hypersensitivity to one of its components is a contraindication (EVER Pharma prescribing information).
  • Seizures — Epilepsy is a contraindication (EVER Pharma prescribing information).
  • Severe renal impairment — A contraindication (EVER Pharma prescribing information).
  • Pediatric use — In a trial in 158 infants with communication defects after severe perinatal brain insult, 0.1 mL/kg was injected twice a week for 5 weeks (Hassanein et al., 2016).
  • Long-term safety — The trials and the prescribing information use courses of 7 to 30 days and dementia cycles of 4 weeks (EVER Pharma prescribing information); no long-term continuous-use study is cited here.
  • Drug interactions — The prescribing information says not to mix it with balanced amino acid solutions, vitamins or cardiovascular medicines (EVER Pharma prescribing information); no interaction study is cited here.

Bloodwork & Monitoring

No guideline-level monitoring is set out in the documents read for this page. The trials measured stroke scales and arm function (Muresanu et al., 2016; Heiss et al., 2012), a multi-scale outcome ensemble after brain injury (Vester et al., 2021) and adverse events; the prescribing information lists epilepsy and severe renal impairment as contraindications (EVER Pharma prescribing information).

Commonly Stacked With

In the trials, Cerebrolysin was given on top of standard care, not instead of it (Heiss et al., 2012; Muresanu et al., 2016; Vester et al., 2021).

Standard stroke care

In CASTA, Cerebrolysin was given with aspirin (Heiss et al., 2012); in CAPTAIN, on top of standard care for brain injury (Vester et al., 2021).

Neurorehabilitation (physical / speech / occupational therapy)

In CARS, everyone also had a standardized 21-day rehabilitation program, started within 72 hours of the stroke (Muresanu et al., 2016).

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Legal Status

Current Status — April 2026

Cerebrolysin is not approved by the U.S. FDA for any indication. It is also not centrally approved by the European Medicines Agency, although national-authority approvals exist in several EU member states.

Its maker, EVER Neuro Pharma of Austria, holds its marketing authorisation there, and it is registered in Russia as a prescription medicine (EVER Neuro Pharma prescribing information; RLS, 2026). Its maker’s websites give no list or count of the countries that approve it (searched October 11, 2026).

A 2021 guideline of the European Academy of Neurology and the European Federation of Neurorehabilitation Societies recommends Cerebrolysin, 30 mL a day by IV for at least 10 days, for early neurorehabilitation after acute ischemic stroke (Beghi et al., 2021; PMID 34152062). The 2023 Cochrane stroke review (PMID 37818733) concluded with moderate certainty that Cerebrolysin probably has no effect on all-cause death after acute ischemic stroke, and may increase non-fatal serious adverse events — the most rigorous independent counter-position.

Cerebrolysin is not named on the WADA Prohibited List; because it is approved as a medicine in Russia and other countries, the S0 rule for non-approved substances does not apply to it (WADA Prohibited List 2026).

Cerebrolysin is not on the FDA Category 2 Bulk Drug Substances list, and it was not among the 12 peptides FDA removed from that list in April 2026 (FDA 503A categories list, April 22, 2026). As a porcine-brain enzymatic hydrolysate (a complex biological extract), it would likely require formal NDA / BLA review for any U.S. regulatory pathway, not the bulk-substance compounding framework that applies to defined-structure peptides like BPC-157 or GHK-Cu.

Cost & Access

Cerebrolysin is not approved for human use in the United States. It is available through research suppliers for laboratory research purposes only.

Where it is approved, it is available only on prescription and in pharmacies (EVER Neuro Pharma prescribing information). Its maker says it is not registered with the FDA and not approved for sale or distribution in the United States (EVER Neuro Pharma), and it is on none of FDA’s 503A bulk-substance lists (FDA 503A categories list, May 14, 2026).

Cerebrolysin was not among the 12 peptides FDA removed from Category 2 in April 2026 (FDA 503A categories list, April 22, 2026). Absent a sponsor advancing Cerebrolysin through the U.S. NDA / BLA pathway (highly unlikely given the compound's age, off-patent status, and complexity of regulatory characterization for a multi-component biological extract), it will remain unavailable through legitimate U.S. clinical channels for the foreseeable future.

Estimated pricing as of April 2026. Actual costs vary by provider, location, and prescription status. Kalios does not sell compounds.

References

  1. Muresanu DF, Heiss WD, Hoemberg V, Bajenaru O, Popescu CD, Vester JC, Rahlfs VW, Doppler E, Meier D, Moessler H, Guekht A. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016;47(1):151-159. PMID: 26564102.
  2. Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z; Cerebrolysin Acute Stroke Treatment in Asia (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. Bornstein NM, Guekht A, Vester J, Heiss WD, Gusev E, Hömberg V, Rahlfs VW, Bajenaru O, Popescu BO, Muresanu D. 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. PMID: 29248999.
  4. Gharagozli K, Harandi AA, Houshmand S, Akbari N, Muresanu DF, Vester J, Winter S, Moessler H. Efficacy and safety of Cerebrolysin treatment in early recovery after acute ischemic stroke: a randomized, placebo-controlled, double-blinded, multicenter clinical trial. J Med Life. 2017;10(3):153-160. PMID: 29075343.
  5. Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023;10(10):CD007026. PMID: 37818733. (The 2023 Cochrane independent appraisal — the most methodologically conservative review available; concluded probable no effect on all-cause mortality or functional independence.)
  6. Cui S, Chen N, Yang M, Guo J, Zhou M, Zhu C, He L. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019;(11):CD008900. PMID: 31710397. (Six-RCT review; beneficial cognitive and global signal; rated low-certainty.)
  7. Chen N, Yang M, Guo J, Zhou M, Zhu C, He L. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2013;(1):CD008900. PMID: 23440834. (Original 2013 Cochrane vascular-dementia review.)
  8. 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.
  9. Poon W, Vos P, Muresanu D, Vester J, von Wild K, Hömberg V, et al. Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I — a randomized, placebo-controlled, double-blind, Asian-Pacific trial. Neurol Sci. 2020;41(2):281-293. PMID: 31494820.
  10. Muresanu DF, Florian S, Hömberg V, Matula C, von Steinbüchel N, Vos PE, von Wild K, Birle C, Muresanu I, Slavoaca D, Rosu OV, Strilciuc S, Vester J. 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. PMID: 31897941.
  11. Vester JC, Buzoianu AD, Florian SI, Hömberg V, Kim SH, Lee TMC, Matula C, Poon WS, von Steinbüchel N, Strilciuc S, von Wild K, Muresanu D. Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series. Neurol Sci. 2021;42(2):589-598. PMID: 33620612.
  12. Brainin M. Cerebrolysin: a multi-target drug for recovery after stroke. Expert Rev Neurother. 2018;18(8):681-687. PMID: 30004268.
  13. Rejdak K, Sienkiewicz-Jarosz H, Bienkowski P, Alvarez A. Modulation of neurotrophic factors in the treatment of dementia, stroke and TBI: Effects of Cerebrolysin. Med Res Rev. 2023;43(5):1668-1700. PMID: 37052231.
  14. Woo PYM, Ho JWK, Ko NMW, Li RPT, Jian L, Chu ACH, Kwan MCL, Chan Y, Wong AKS, Wong HT, Chan KY, Kwok JCK. Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage. BMC Neurol. 2020;20(1):401. PMID: 33143640.
  15. Hassanein SM, Deifalla SM, El-Houssinie M, Mokbel SA. Safety and Efficacy of Cerebrolysin in Infants with Communication Defects due to Severe Perinatal Brain Insult: A Randomized Controlled Clinical Trial. J Clin Neurol. 2016;12(1):79-84. PMID: 26365023.
  16. Jianu DC, Muresanu DF, Bajenaru O, Popescu BO, Deme SM, Moessler H, Meinzingen SZ, Petrica L. Cerebrolysin adjuvant treatment in Broca's aphasics following first acute ischemic stroke of the left middle cerebral artery. J Med Life. 2010;3(3):297-307. PMID: 20945821.
  17. Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z. A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with acute ischaemic stroke in Asia — CASTA. Int J Stroke. 2010;5(4):310-313. PMID: 19765131.
  18. Ladurner G, Kalvach P, Moessler H; Cerebrolysin Study Group. Neuroprotective treatment with cerebrolysin in patients with acute stroke: a randomised controlled trial. J Neural Transm (Vienna). 2005;112(3):415-428. PMID: 15583955.
  19. Onose G, Mureşanu DF, Ciurea AV, Daia Chendreanu C, et al. Neuroprotective and consequent neurorehabilitative clinical outcomes in patients treated with the pleiotropic drug cerebrolysin. J Med Life. 2009;2(4):350-360. PMID: 20108748.
  20. Rockenstein E, Adame A, Mante M, Moessler H, Windisch M, Masliah E. The neuroprotective effects of Cerebrolysin in a transgenic model of Alzheimer's disease are associated with improved behavioral performance. J Neural Transm (Vienna). 2003;110(11):1313-1327. PMID: 14628195.
  21. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (503A categories list), versions updated April 15, April 22 and May 14, 2026. fda.gov/media/94155/download. Read October 3, 2026. (Notice that 12 peptides would leave Category 2 because their nominations were withdrawn; their removal; GHK-Cu, except injectable, back in Category 1.)
  22. World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S0, Non-approved substances. wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf. Read October 3, 2026.
  23. Beghi E, Binder H, Birle C, et al. European Academy of Neurology and European Federation of Neurorehabilitation Societies guideline on pharmacological support in early motor rehabilitation after acute ischaemic stroke. Eur J Neurol. 2021;28(9):2831-2845. PMID: 34152062.
  24. EVER Neuro Pharma. Cerebrolysin dosage recommendation, with abbreviated prescribing information (CERE/INT/12/2018/19). cerebrolysin.com. Read October 4, 2026.
  25. EVER Neuro Pharma. Cerebrolysin website: product information “based on the Austrian Summary of Product Characteristics”, and Notice to U.S. Visitors (“not registered with the U.S. Food and Drug Administration (FDA) and is not approved for sale or distribution in the United States”). cerebrolysin.com. Read October 11, 2026.
  26. RLS (Register of Medicinal Products of Russia). Церебролизин® (Cerebrolysin®), solution for injection: registration holder EVER Neuro Pharma GmbH, Austria; dispensed on prescription. rlsnet.ru/drugs/cerebrolizin-3362. Description agreed May 21, 2026; read October 11, 2026.

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Checked 11 Oct 2026