Cerebrolysin
Cerebrolysin is a porcine-brain hydrolysate mixture measured in milliliters, not one defined peptide. In stroke recovery, the 1,070-person CASTA trial was neutral while the 208-person CARS trial improved the day-90 arm-test result. A Cochrane review found no reliable overall functional benefit, and vascular-dementia evidence remains very uncertain.
porcine-brain peptide hydrolysate
- Porcine-brain protein hydrolysate
- No single sequence or molecular mass
- Stroke evidence is mixed with neutral large trials
- Current studies dose a finished mixture by volume
What exactly is Cerebrolysin?
Cerebrolysin is a finished porcine-brain protein hydrolysate containing many peptides and free amino acids. It has no single sequence, molecular formula, mass, receptor, or dose in milligrams of one active ingredient.
Composition study · fingerprints, no active moiety
Analytical in vitro study
Seidl LF, Aigner L. Journal of Medicine and Life, 2024.
The study compared chromatographic fingerprints and in vitro activity among porcine-brain hydrolysates using an originator reference. It does not identify one active peptide or show that market products are clinically interchangeable.
- Study design
- Laboratory analytical comparison
- Funding
- Originator material was supplied for comparison
EU CTIS · active academic trial and Romanian authorization
EU clinical-trial registry record
EU CTIS 2024-515591-12-00.
The public record describes an authorized 440-person academic trial and identifies Romanian national marketing authorization 4610/2004/03 for the product used. The trial registration does not yet supply a result and the national authorization does not imply US or EU-central approval.
- Participants / model
- Planned 440-person stroke-recovery population
- Treatment
- Cerebrolysin within a randomized academic trial
- Study design
- Authorized prospective clinical-trial registration
Useful for current research and one specific national authorization only.
Read the original sourceDoes Cerebrolysin improve stroke recovery?
The compound-specific Cochrane review included seven trials with 1,601 participants and found no reliable functional benefit. CASTA’s global endpoint was neutral; the smaller CARS rehabilitation trial was positive; and a small Chinese three-arm trial reported short-term benefit but excluded 24 of 84 randomized participants without explaining why.
| Source | Denominator | Functional result |
|---|---|---|
| Cochrane 2020 | 7 trials, 1,601 people | No clear clinical benefit; no poolable poor-outcome result |
| CASTA | 1,070 randomized | Confirmatory global endpoint neutral |
| CARS | 208 randomized | Positive arm-motor distribution at day 90 |
| Chinese three-arm trial | 84 randomized; 60 analyzed | Cerebrolysin better than placebo at day 21; unexplained post-randomization loss |
Cochrane 2020 · no proven clinical benefit
Systematic review of randomized trials
Ziganshina LE et al. Cochrane Database of Systematic Reviews, 2020.
Seven randomized trials with 1,601 participants did not show a clear clinical benefit. All-cause mortality risk ratio was 0.90 (95% CI 0.61 to 1.32); total serious adverse events risk ratio was 1.15 (0.81 to 1.65). Nonfatal serious adverse events were more frequent with Cerebrolysin, risk ratio 2.15 (1.01 to 4.55). The trials did not supply a poolable poor-functional-outcome result.
- Participants / model
- 1,601 participants across 7 acute ischemic stroke trials
- Treatment
- Cerebrolysin added to standard care versus placebo or no Cerebrolysin
- Study design
- Compound-specific Cochrane systematic review
The 2023 update broadened scope to similar animal-derived agents and should not be used for exact Cerebrolysin denominators.
Read the original sourceCASTA · 1,070 randomized, global endpoint neutral
Randomized double-blind trial
Heiss WD et al. Stroke, 2012.
The 1,070-person trial did not show a significant benefit on its confirmatory global endpoint. A modified Rankin score of 0 to 2 occurred in 199 of 529 Cerebrolysin recipients and 208 of 541 placebo recipients.
- Participants / model
- 1,070 people with acute ischemic stroke
- Treatment
- Cerebrolysin or placebo added to standard treatment
- Follow-up
- Acute treatment with 90-day outcome assessment
- Study design
- Large multicenter randomized double-blind placebo-controlled trial
CARS · positive smaller trial
Randomized double-blind trial
Muresanu DF et al. Stroke, 2016.
In 208 people receiving standardized rehabilitation after stroke, the Cerebrolysin arm had a better Action Research Arm Test distribution at day 90. The trial was much smaller than CASTA, and registry materials distinguish the prespecified analysis from later summaries.
- Participants / model
- 208 people with severe arm motor impairment after acute ischemic stroke
- Treatment
- Cerebrolysin plus standardized rehabilitation or placebo plus rehabilitation
- Follow-up
- 21-day treatment with 90-day assessment
- Study design
- Randomized double-blind placebo-controlled trial
- Funding
- Manufacturer involvement and author network disclosed in the publication
A positive smaller trial does not erase the neutral large confirmatory study.
Read the original sourceChina RCT · 84 randomized, 60 analyzed
Randomized double-blind trial
Xue LX et al. Experimental and Therapeutic Medicine, 2016.
The report says 84 people with acute ischemic stroke were randomized, but analyzes only 60 who received study intervention, 20 each with butylphthalide, Cerebrolysin, or saline placebo. At day 21, Cerebrolysin showed better NIH Stroke Scale and Barthel Index scores than placebo at reported P<0.05. Butylphthalide produced a larger NIH Stroke Scale improvement than Cerebrolysin, while their Barthel improvement did not significantly differ. The paper does not explain the 24-person randomized-to-analyzed loss, and follow-up ended at 21 days.
- Participants / model
- 84 Chinese adults randomized within 12 hours of acute ischemic stroke; 60 analyzed, 20 per arm
- Treatment
- Ten days of intravenous butylphthalide, Cerebrolysin 30 mL daily, or saline placebo plus routine care
- Follow-up
- Ten-day treatment with assessments through day 21
- Study design
- Single-center randomized double-blind three-arm trial with unexplained post-randomization exclusion
The analyzed cohort is smaller than the randomized cohort.
Read the original sourceDoes it improve dementia?
Vascular-dementia trials show possible small score changes, but Cochrane rated the evidence very low certainty and questioned clinical importance. This is not proof of durable preservation of independence or cognition.
Cochrane dementia · very-low-certainty signals
Systematic review of randomized trials
Cui S et al. Cochrane Database of Systematic Reviews, 2019.
Six trials with 597 participants suggested small cognitive and global-response effects, but certainty was rated very low because of study limitations, inconsistency, and imprecision. The review warns that the cognitive effect may be too small to be clinically important.
- Participants / model
- 597 participants across 6 vascular-dementia trials
- Treatment
- Cerebrolysin versus placebo
- Study design
- Cochrane systematic review
Glasgow review · very-low-certainty evidence
Independent systematic review
Alsulaimani RA, Quinn TJ. Cerebral Circulation, Cognition and Behavior, 2021.
The review separated animal-derived preparations and judged the Cerebrolysin evidence very low certainty. Short-term signals were not consistently maintained, and clinically meaningful functional outcomes were uncertain.
- Study design
- Systematic review from University of Glasgow authors
What is the proposed mechanism?
Laboratory and animal studies report neurotrophic, inflammatory, neurogenesis, and recovery effects, but the mixture’s active components and human exposure-response relationship are unresolved. A chromatographic fingerprint is identity control, not proof of a single active factor.
Composition study · fingerprints, no active moiety
Analytical in vitro study
Seidl LF, Aigner L. Journal of Medicine and Life, 2024.
The study compared chromatographic fingerprints and in vitro activity among porcine-brain hydrolysates using an originator reference. It does not identify one active peptide or show that market products are clinically interchangeable.
- Study design
- Laboratory analytical comparison
- Funding
- Originator material was supplied for comparison
What does the randomized safety record show?
The 2020 Cochrane analysis did not find a clear mortality or total-serious-adverse-event difference, but it found more nonfatal serious adverse events with Cerebrolysin. Product composition, batch comparability, hypersensitivity, interactions, pregnancy, and long-term repeated exposure remain incompletely defined.
Cochrane 2020 · no proven clinical benefit
Systematic review of randomized trials
Ziganshina LE et al. Cochrane Database of Systematic Reviews, 2020.
Seven randomized trials with 1,601 participants did not show a clear clinical benefit. All-cause mortality risk ratio was 0.90 (95% CI 0.61 to 1.32); total serious adverse events risk ratio was 1.15 (0.81 to 1.65). Nonfatal serious adverse events were more frequent with Cerebrolysin, risk ratio 2.15 (1.01 to 4.55). The trials did not supply a poolable poor-functional-outcome result.
- Participants / model
- 1,601 participants across 7 acute ischemic stroke trials
- Treatment
- Cerebrolysin added to standard care versus placebo or no Cerebrolysin
- Study design
- Compound-specific Cochrane systematic review
The 2023 update broadened scope to similar animal-derived agents and should not be used for exact Cerebrolysin denominators.
Read the original sourceComposition study · fingerprints, no active moiety
Analytical in vitro study
Seidl LF, Aigner L. Journal of Medicine and Life, 2024.
The study compared chromatographic fingerprints and in vitro activity among porcine-brain hydrolysates using an originator reference. It does not identify one active peptide or show that market products are clinically interchangeable.
- Study design
- Laboratory analytical comparison
- Funding
- Originator material was supplied for comparison
Where is Cerebrolysin authorized?
A CTIS record identifies a Romanian national marketing authorization and an active academic trial. The cited U.S. FDA records list no approved-drug application for Cerebrolysin. A national authorization should not be generalized into approval everywhere.
EU CTIS · active academic trial and Romanian authorization
EU clinical-trial registry record
EU CTIS 2024-515591-12-00.
The public record describes an authorized 440-person academic trial and identifies Romanian national marketing authorization 4610/2004/03 for the product used. The trial registration does not yet supply a result and the national authorization does not imply US or EU-central approval.
- Participants / model
- Planned 440-person stroke-recovery population
- Treatment
- Cerebrolysin within a randomized academic trial
- Study design
- Authorized prospective clinical-trial registration
Useful for current research and one specific national authorization only.
Read the original sourceDrugs@FDA/openFDA · no U.S. record
Regulatory database record set
Drugs@FDA and openFDA records.
Drugs@FDA and openFDA contained no exact-name U.S. approved-drug application. This does not negate national authorization in Romania or other jurisdictions.
- Study design
- Exact-name U.S. approval coverage
Studies and sources
Cochrane 2020 · no proven clinical benefit
Systematic review of randomized trials
Ziganshina LE et al. Cochrane Database of Systematic Reviews, 2020.
Seven randomized trials with 1,601 participants did not show a clear clinical benefit. All-cause mortality risk ratio was 0.90 (95% CI 0.61 to 1.32); total serious adverse events risk ratio was 1.15 (0.81 to 1.65). Nonfatal serious adverse events were more frequent with Cerebrolysin, risk ratio 2.15 (1.01 to 4.55). The trials did not supply a poolable poor-functional-outcome result.
- Participants / model
- 1,601 participants across 7 acute ischemic stroke trials
- Treatment
- Cerebrolysin added to standard care versus placebo or no Cerebrolysin
- Study design
- Compound-specific Cochrane systematic review
The 2023 update broadened scope to similar animal-derived agents and should not be used for exact Cerebrolysin denominators.
Read the original sourceCASTA · 1,070 randomized, global endpoint neutral
Randomized double-blind trial
Heiss WD et al. Stroke, 2012.
The 1,070-person trial did not show a significant benefit on its confirmatory global endpoint. A modified Rankin score of 0 to 2 occurred in 199 of 529 Cerebrolysin recipients and 208 of 541 placebo recipients.
- Participants / model
- 1,070 people with acute ischemic stroke
- Treatment
- Cerebrolysin or placebo added to standard treatment
- Follow-up
- Acute treatment with 90-day outcome assessment
- Study design
- Large multicenter randomized double-blind placebo-controlled trial
CARS · positive smaller trial
Randomized double-blind trial
Muresanu DF et al. Stroke, 2016.
In 208 people receiving standardized rehabilitation after stroke, the Cerebrolysin arm had a better Action Research Arm Test distribution at day 90. The trial was much smaller than CASTA, and registry materials distinguish the prespecified analysis from later summaries.
- Participants / model
- 208 people with severe arm motor impairment after acute ischemic stroke
- Treatment
- Cerebrolysin plus standardized rehabilitation or placebo plus rehabilitation
- Follow-up
- 21-day treatment with 90-day assessment
- Study design
- Randomized double-blind placebo-controlled trial
- Funding
- Manufacturer involvement and author network disclosed in the publication
A positive smaller trial does not erase the neutral large confirmatory study.
Read the original sourceChina RCT · 84 randomized, 60 analyzed
Randomized double-blind trial
Xue LX et al. Experimental and Therapeutic Medicine, 2016.
The report says 84 people with acute ischemic stroke were randomized, but analyzes only 60 who received study intervention, 20 each with butylphthalide, Cerebrolysin, or saline placebo. At day 21, Cerebrolysin showed better NIH Stroke Scale and Barthel Index scores than placebo at reported P<0.05. Butylphthalide produced a larger NIH Stroke Scale improvement than Cerebrolysin, while their Barthel improvement did not significantly differ. The paper does not explain the 24-person randomized-to-analyzed loss, and follow-up ended at 21 days.
- Participants / model
- 84 Chinese adults randomized within 12 hours of acute ischemic stroke; 60 analyzed, 20 per arm
- Treatment
- Ten days of intravenous butylphthalide, Cerebrolysin 30 mL daily, or saline placebo plus routine care
- Follow-up
- Ten-day treatment with assessments through day 21
- Study design
- Single-center randomized double-blind three-arm trial with unexplained post-randomization exclusion
The analyzed cohort is smaller than the randomized cohort.
Read the original sourceCochrane dementia · very-low-certainty signals
Systematic review of randomized trials
Cui S et al. Cochrane Database of Systematic Reviews, 2019.
Six trials with 597 participants suggested small cognitive and global-response effects, but certainty was rated very low because of study limitations, inconsistency, and imprecision. The review warns that the cognitive effect may be too small to be clinically important.
- Participants / model
- 597 participants across 6 vascular-dementia trials
- Treatment
- Cerebrolysin versus placebo
- Study design
- Cochrane systematic review
Glasgow review · very-low-certainty evidence
Independent systematic review
Alsulaimani RA, Quinn TJ. Cerebral Circulation, Cognition and Behavior, 2021.
The review separated animal-derived preparations and judged the Cerebrolysin evidence very low certainty. Short-term signals were not consistently maintained, and clinically meaningful functional outcomes were uncertain.
- Study design
- Systematic review from University of Glasgow authors
Composition study · fingerprints, no active moiety
Analytical in vitro study
Seidl LF, Aigner L. Journal of Medicine and Life, 2024.
The study compared chromatographic fingerprints and in vitro activity among porcine-brain hydrolysates using an originator reference. It does not identify one active peptide or show that market products are clinically interchangeable.
- Study design
- Laboratory analytical comparison
- Funding
- Originator material was supplied for comparison
EU CTIS · active academic trial and Romanian authorization
EU clinical-trial registry record
EU CTIS 2024-515591-12-00.
The public record describes an authorized 440-person academic trial and identifies Romanian national marketing authorization 4610/2004/03 for the product used. The trial registration does not yet supply a result and the national authorization does not imply US or EU-central approval.
- Participants / model
- Planned 440-person stroke-recovery population
- Treatment
- Cerebrolysin within a randomized academic trial
- Study design
- Authorized prospective clinical-trial registration
Useful for current research and one specific national authorization only.
Read the original sourceDrugs@FDA/openFDA · no U.S. record
Regulatory database record set
Drugs@FDA and openFDA records.
Drugs@FDA and openFDA contained no exact-name U.S. approved-drug application. This does not negate national authorization in Romania or other jurisdictions.
- Study design
- Exact-name U.S. approval coverage
Why is Cerebrolysin in D tier?
D reflects inconsistent clinical results, uncertain active components, and weak certainty on patient-important outcomes. Romania has a nationally authorized product, but no US approval record was found.