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Porcine brain-protein hydrolysate · no US product found
Cerebrolysin
Cerebrolysin trials used an IV solution measured in mL. Results varied across stroke and brain-injury studies. They do not set one recovery plan.
- Trial amounts are in mL, not a peptide weight in mg.
- Stroke and brain-injury studies had mixed findings.
- The findings do not establish one general recovery or brain-health schedule.
Cerebrolysin is a biological mixture made from pig (porcine) brain proteins. Controlled digestion breaks the proteins down into small peptides and amino acids. This is not one synthetic peptide with a single sequence, so no single molecular weight describes the mixture.
Human trials report this IV solution in milliliters per treatment day or infusion. The trials reviewed here give no basis for converting these amounts to milligrams of the product, total peptide or any one peptide. Findings also differ by setting.
Two acute-stroke trials found no benefit on their main functional comparisons. An exploratory trial of early stroke rehab favored treatment. In traumatic brain injury (TBI), CAPTAIN I’s primary intention-to-treat analysis found no statistically significant benefit.
CAPTAIN II favored treatment on a combined outcome. These findings do not set a schedule for general recovery or better thinking.
What matters first
- The source unit stays in mL: Trials report an IV solution in mL per day or infusion. They do not support a way to convert mL to peptide mass.
- This is a mixture: One analysis found 638 unique peptides in one sample. That supports its description as a mixture made by breaking down pig brain proteins. It does not show that all lots contain identical peptides.
- The largest acute-stroke trial found no clear benefit: CASTA found no significant difference on its main combined measure at 90 days, which was chosen in advance. Favorable findings in a severe-stroke subgroup came from an analysis chosen after the fact and still need to be confirmed.
- CAPTAIN I’s main result was negative: Its intention-to-treat analysis combined 14 outcomes and found no statistically significant benefit. A per-protocol analysis and three outcomes assessed on their own did favor treatment.
- CAPTAIN I has conflicting repeat schedules: The registry gives a 50 mL/day cycle for 10 days. It says that cycle repeated at one and two months. Repeats depended on the day-30 extended Glasgow Outcome Scale being below 7. The paper abstract instead gives 10 mL/day for 10 days later. It omits the timing and condition for those repeat cycles. The actual repeat schedule remains unresolved.
- Positive results stay tied to the groups studied: CARS studied early arm rehab after stroke. CAPTAIN II used a combined endpoint in moderate-to-severe TBI. Alzheimer’s and vascular-dementia trials enrolled people with diagnosed cognitive disease.
- Current US checks have limits: No product was found in the Drugs@FDA archive. Exact openFDA and DailyMed searches also found none. That finding says nothing about other countries.
Identity and measurement boundary
An early randomized acute-stroke trial describes an enzyme breakdown product of purified brain proteins. It contains small peptides and amino acids. A primary composition analysis describes controlled digestion of porcine brain proteins.
It found 638 unique peptides in one internet-obtained sample. One sample cannot establish the same composition in every manufactured lot.
FDA’s GSRS substance record and UNII record identify CEREBROLYSIN with UNII 37KZM6S21G. They classify it as a structurally diverse ingredient substance. FDA states that a UNII does not imply regulatory review or approval.
The amounts below are in mL, with the infusion setting stated for each study. These data do not give a way to convert the volume to mg of product, total peptide or any single peptide.
Acute ischemic stroke
CASTA: no clear benefit on the main measure
The CASTA trial randomized 1,070 people with acute ischemic hemispheric stroke. They entered within 12 hours of symptom onset. One group received cerebrolysin 30 mL/day by IV infusion for 10 days.
It also received aspirin 100 mg/day. The control group received saline infusion and the same aspirin schedule.
The main combined test at 90 days was chosen in advance and found no significant difference between groups. It used the modified Rankin Scale, Barthel Index and NIH Stroke Scale. A subgroup with baseline NIHSS above 12 was analyzed after the fact and showed favorable trends and lower death rates.
The authors said another trial was needed to check this finding. It does not prove a benefit or change the main result.
Earlier 21-day trial: no main functional improvement
The earlier acute-stroke trial randomized 146 people within 24 hours of stroke onset. It compared 50 mL/day by IV for 21 days with placebo. Both groups also received oral aspirin 250 mg/day.
They also received IV pentoxifylline 300 mg/day.
Treatment showed no significant gain on the Canadian Neurological Scale, Barthel Index or Clinical Global Impressions. One test of thinking skills favored treatment, and adverse events occurred at similar rates. This small exploratory study does not establish broad benefit or safety.
These were acute hospital treatments over defined periods. Neither trial sets a general post-stroke schedule. They also do not set a long-term recovery or prevention schedule.
Early rehabilitation after stroke
The CARS randomized multicenter trial compared cerebrolysin 30 mL/day by IV with saline. Treatment was once daily for 21 days. It began 24–72 hours after stroke.
Both groups began the same standardized 21-day rehab program within 72 hours.
The official CARS results record confirms IV use in its arm description and dosage fields. It separates the 30 mL drug amount from the diluted infusion volume. The paper abstract alone does not state the route.
At day 90, the primary Action Research Arm Test favored treatment. Its Mann–Whitney effect-size estimate was 0.71 (95% CI 0.63–0.79; p<0.0001). In this analysis, 0.5 means no difference between groups, and higher values favor treatment.
A 12-scale global analysis also favored treatment. Its estimate was 0.62 (95% CI 0.58–0.65; p<0.0001). Four of 104 people in the drug group and eight of 104 in the placebo group left the study early.
Reported safety was comparable with placebo.
The study team called CARS exploratory and fairly small, and asked for a large trial to confirm its findings. The result concerns arm function during early stroke rehab, with both groups in the same rehab program. It does not show that the drug prevents stroke, helps long-term recovery or works outside that care setting.
Moderate-to-severe traumatic brain injury
CAPTAIN I: negative primary analysis and unresolved schedule conflict
The CAPTAIN I paper abstract reports 46 people with moderate-to-severe TBI. The trial added cerebrolysin or saline to local standard care. The abstract gives 50 mL/day for 10 days, then two more 10-day cycles at 10 mL/day.
It does not state when the later cycles took place or what conditions had to be met to receive them.
The planned intention-to-treat analysis compared people by their assigned group across 14 outcomes. It found no statistically significant benefit, and its confidence interval included the value for no effect. A per-protocol analysis, based on how closely people followed the study plan, favored treatment, as did three outcomes assessed on their own.
Reported safety was similar with the drug and placebo. The authors called for a larger randomized trial; the favorable analyses do not replace the negative main result.
The NCT01606111 registry record lists actual enrollment of 46 people. It says the study stopped because too few people enrolled. Its treatment text gives 50 mL/day by IV for 10 days.
The registry says that 50 mL/day cycle repeated at one and two months if the day-30 extended Glasgow Outcome Scale score was below 7.
The registry gives 50 mL repeat cycles under a stated condition, while the paper abstract gives later 10 mL cycles. Neither source shows which repeat schedule was actually given, and they cannot be combined to create one. To settle the conflict, we would need the full protocol, statistical analysis plan or final study report.
CAPTAIN II: a favorable combined result in the TBI group studied
The CAPTAIN II abstract reports a saline-controlled trial at one center. It enrolled 142 people with Glasgow Coma Scale scores of 7–12. Of these, 139 entered the formal analysis.
The paper gives 50 mL/day for 10 days. It then gives two more 10-day cycles at 10 mL/day. It does not give the interval for those later cycles.
At day 90, the combined analysis of 13 outcomes chosen in advance favored treatment. Its Mann–Whitney estimator was 0.59 (95% CI 0.52–0.66; p=0.0119). Reported safety was similar between groups.
The combined result applies to the moderate-to-severe TBI group studied; it does not mean that every outcome improved. It gives no basis for use in mild TBI, concussion or healthy people, or for general recovery from brain injury or disease.
Cognitive-disease populations
Alzheimer’s disease
A 28-week Alzheimer’s disease trial included 149 people with mild-to-moderate disease. They received 30 mL by IV infusion or placebo. Treatment was five days per week for four weeks.
They then had a two-month treatment-free interval. The same course was then repeated.
At week 16, Clinical Global Impression responder rates were 63.5% with treatment. The placebo rate was 41.4%. The ADAS-cog scale measures cognitive symptoms; its full name is the Alzheimer’s Disease Assessment Scale-cognitive subpart.
The treatment difference was 3.2 points. Adverse events were reported in 43% with treatment and 38% with placebo. These findings concern people with diagnosed Alzheimer’s disease.
They do not show that the drug improves thinking in healthy people.
Vascular dementia
A vascular-dementia trial included 242 people. It compared cerebrolysin 20 mL by IV once daily with placebo. Both were added to aspirin over two treatment cycles.
At week 24, cognition and the clinician-rated global outcome favored treatment. ADAS-cog+ is the extended cognitive scale. Its least squares treatment difference was −6.17 points.
The abstract says the treatment was well tolerated but does not state how many days either cycle lasted. That gap cannot be filled with a schedule from a stroke, TBI or Alzheimer’s trial. These findings in people with disease do not show that the drug improves thinking in healthy people.
Current research and US regulatory checks
The current ClinicalTrials.gov intervention query returned 42 records. Of these, 19 were completed. Another 11 had unknown status.
Four were recruiting, three terminated and two not yet recruiting. One each was withdrawn, enrolling by invitation, and active but not recruiting. A registry entry describes a study that is planned or recorded.
It is not a result or an approval decision.
FDA describes Drugs@FDA as its approved-product database. Its September 4, 2026 data page and 12-table archive contain no case-insensitive match for cerebrolysin. They also contain none for cerebroprotein hydrolysate or porcine brain.
The exact openFDA ingredient query returned HTTP 404 “No matches found.” The exact DailyMed search returned zero records.
The US sources reviewed showed no product, and a GSRS or UNII identity record is not proof of approval. This finding applies only to those US databases; it says nothing about whether the drug is approved or sold in other countries.
Reader questions
Is cerebrolysin one peptide?
No. Primary sources describe a mixture made by breaking down pig brain proteins. It contains many small peptides and amino acids.
One analysis found 638 unique peptides in one sample. That does not show the same mix in every lot.
How many milligrams are in a studied cerebrolysin dose?
The trials report the IV solution in mL per treatment day or infusion. They do not provide a supported conversion to mg of the product, total peptide or any single peptide.
Did cerebrolysin improve acute-stroke outcomes?
Not on the main comparisons in the two acute-stroke trials reviewed. CASTA found no clear benefit on its planned combined measure at 90 days. The earlier trial found no significant gain on its three measures of neurologic status, function and global status.
CARS later found a benefit for arm function when it compared the drug with saline during the same early rehab program. That trial used a different care setting, so these results answer different questions.
What did the traumatic-brain-injury trials find?
CAPTAIN I’s primary intention-to-treat analysis combined 14 outcomes. It did not reach statistical significance. Per-protocol and individual analyses did favor treatment.
CAPTAIN II combined 13 outcomes at day 90. It reported a significant result in a larger moderate-to-severe TBI group. A favorable combined result does not mean every outcome improved.
Nor does it establish a general recovery use.
What was the CAPTAIN I repeat-cycle schedule?
The reviewed sources conflict. The registry gives a 50 mL/day cycle for 10 days. It repeats at one and two months under a condition.
The day-30 extended Glasgow Outcome Scale had to be below 7. The paper abstract instead gives two later 10-day cycles at 10 mL/day. It omits their timing and condition.
Neither account establishes the actual repeat schedule without fuller trial records.
Do the Alzheimer’s and vascular-dementia trials show a nootropic effect?
No. Those trials measured effects in people with diagnosed Alzheimer’s disease or vascular dementia. They do not show that the drug improves thinking in healthy people or set a schedule to prevent disease in that group.
Is cerebrolysin approved in the United States?
No product was found in the current Drugs@FDA archive. Exact openFDA and DailyMed searches also found none. FDA substance and UNII records identify an ingredient.
They do not establish product approval. This finding covers only the current US sources checked.
Can these trial amounts be used as a personal schedule?
No. These IV schedules were studied in acute hospital care, rehab, traumatic brain injury or diagnosed diseases that affect thinking. They do not set a schedule for recovery or better thinking to use on your own.