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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 porcine brain proteins. The proteins undergo controlled digestion. The mixture contains small peptides and amino acids.
It is not one synthetic peptide with a single sequence. Nor can it be assigned one defensible molecular weight.
Human trials report this IV solution in milliliters. The amount is per treatment day or infusion. No supported conversion to milligrams of “cerebrolysin” exists.
None is supported for total peptide either. The same applies to any single 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. CAPTAIN I missed its primary intention-to-treat analysis in TBI.
CAPTAIN II favored treatment on a combined TBI outcome. These findings do not combine into a general recovery or nootropic schedule.
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 identity as broken-down porcine protein. It does not show that all lots contain identical peptides.
- The largest acute-stroke trial was neutral: CASTA set its main global endpoint at 90 days in advance. It found no significant difference. Favorable findings in a severe-stroke subgroup came from a post hoc analysis. They still need confirmation.
- CAPTAIN I’s primary result was negative: Its intention-to-treat analysis combined 14 outcomes. That result did not reach statistical significance. A per-protocol analysis and three individual outcomes 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 stay in mL. Each keeps its infusion setting. The studies do not support a conversion to mg of product.
They also do not support mg of total peptide or any single peptide. A mass equivalent cannot be derived from those data.
Acute ischemic stroke
CASTA: neutral prespecified outcome
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 prespecified 90-day global test found no significant treatment difference. It combined the modified Rankin Scale, Barthel Index and NIH Stroke Scale. A post hoc subgroup had baseline NIHSS above 12.
That subgroup had favorable trends and lower observed mortality. The authors said another trial was needed to check this finding. The main endpoint was neutral.
That finding governs the conclusion. The subgroup does not establish a benefit.
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 did not significantly improve the Canadian Neurological Scale. It also did not significantly improve the Barthel Index or Clinical Global Impressions. One cognitive test favored treatment.
Adverse events occurred at similar rates. This was a small exploratory study. It 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 estimator was 0.71 (95% CI 0.63–0.79; p<0.0001). A 12-scale global analysis also favored treatment.
Its estimate was 0.62 (95% CI 0.58–0.65; p<0.0001). Stopping early was 3.8%. Reported safety was comparable with placebo.
The study team called CARS exploratory and fairly small. They called for a large trial to confirm the finding. The finding concerns arm function during early stroke rehab.
Both groups had the same rehab program. It does not establish stroke prevention or chronic recovery. Nor does it establish use 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. Cerebrolysin was added to local standard care. Saline served as control.
The abstract gives 50 mL/day for 10 days. It then gives two more 10-day cycles at 10 mL/day. It does not state when the later cycles occurred.
Nor does it say whether they depended on a condition.
The prespecified intention-to-treat analysis combined 14 outcomes. It did not reach statistical significance. Its confidence interval crossed the null.
A per-protocol analysis and three individual outcomes favored treatment. Reported safety was comparable with placebo. The authors called for a larger randomized trial.
The favorable analyses do not replace the negative primary intention-to-treat result.
The directly fetched NCT01606111 registry record lists 46 actual people. It says the study stopped because too few people enrolled. Its treatment text gives 50 mL/day by IV for 10 days.
That 50 mL cycle repeated at one and two months under a condition. The day-30 extended Glasgow Outcome Scale had to be below 7.
The registry gives conditional 50 mL repeat cycles. The paper abstract gives later 10 mL cycles. The reviewed sources do not establish which amount was actually given.
Both accounts must remain visible and the schedule unresolved. Resolution needs the full protocol, statistical analysis plan or final study report. Neither account can be chosen as the actual schedule yet.
They also cannot be averaged or used to construct a schedule.
CAPTAIN II: favorable multivariate endpoint in a specific TBI cohort
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 prespecified combined analysis of 13 outcomes favored treatment. Its Mann–Whitney estimator was 0.59 (95% CI 0.52–0.66; p=0.0119). Reported safety was comparable between groups.
This combined result concerns a defined moderate-to-severe TBI group. It does not mean that every component outcome improved. It also does not establish use in mild TBI or concussion.
Nor does it establish use in healthy people or general neurologic recovery.
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 treatment difference was 3.2 points.
Adverse events were reported in 43% with treatment and 38% with placebo. These findings concern people diagnosed with Alzheimer’s disease. They do not show cognitive enhancement 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. The ADAS-cog+ least squares treatment difference was −6.17 points.
The abstract reports favorable tolerability. It does not state how many days either cycle lasted. That duration remains unavailable.
It cannot be borrowed from a stroke, TBI or Alzheimer’s protocol. This disease-specific finding does not establish nootropic use 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.
No product was found in the current US sources checked. GSRS and UNII identity records do not establish approval. This finding concerns only the US databases checked.
It says nothing about approval or marketing in other countries.
Reader questions
Is cerebrolysin one peptide?
No. Primary sources describe a hydrolysate made from porcine brain proteins. It contains many small peptides.
It also contains 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 support mg of product or total peptide. Nor do they support mg of any single peptide.
The amounts stay in mL without an invented mass equivalent.
Did cerebrolysin improve acute-stroke outcomes?
Not on the main comparisons in the two acute-stroke trials reviewed. CASTA’s prespecified 90-day global endpoint was neutral. The earlier trial found no significant gain on three named measures.
Those measures covered neurologic status, function and global status. CARS later favored treatment on an arm-function endpoint. It paired early rehab with a standardized rehab program.
That was a different setting. 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 enrolled people with diagnosed Alzheimer’s disease or vascular dementia. They measured disease-specific outcomes.
They do not establish cognitive enhancement in healthy people. Nor do they set a preventive schedule for healthy people.
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 come from research in acute hospital care. Others come from rehab.
Others concern TBI or a diagnosed disease that affects thinking. They do not set a recovery or nootropic schedule to use on your own.