Cerebrolysin
An injectable pig brain mixture with mixed stroke, brain-injury and dementia evidence.
Also called: FPF-1070, Cerebrolysin concentrate.
Nootropic peptides · Porcine brain-derived peptide and amino-acid mixture · Evidence: Approved drug.
What Cerebrolysin does
Cerebrolysin is an injectable mix of pig brain peptides and amino acids, with mixed recovery results and uncertain healthy-person benefits and long-term safety. Cochrane found no survival benefit after acute stroke and a possible rise in serious nonfatal harms. Some stroke and brain-injury trials report gains. National approvals exist in parts of Europe and Asia, but no FDA approval.
- In Austria, doctors use it for patients after a stroke or head injury and for some kinds of dementia; it is not FDA approved. (Studied in a trial)
- In stroke rehab trials, people's arm recovery was better with it, though the gain was smaller when trials were pooled. (Studied in a trial)
- After brain injury, a trial found a small gain in daily function and thinking, but the evidence rests on two small trials. (Studied in a trial)
- People report better mood, memory or sleep and less anxiety, though these goals lack strong clinical evidence. (Reported by users)
Uses in the sources
- Nationally approved in Austria for support after stroke and head injury, and for Alzheimer-type or vascular dementia. (Clinician-published) (source)
- Studied alongside stroke rehabilitation and standard TBI care; results differ across trials. (Studied in a trial) (source)
- Reported online for memory, mood and recovery from past substance use; these goals lack convincing clinical evidence. (Reported by users) (source)
Cerebrolysin dosage
Typical reported dose: 30 mL by IV drip once a day for at least 10 days
- CASTA: 30 mL: 30 mL once daily once daily, into a vein. Studied in a trial. Studied in: Ischemic stroke within 12 hours. (source)
- Alteplase trial: 30 mL: 30 mL once daily once daily, into a vein. Studied in a trial. Studied in: Ischemic stroke receiving alteplase within 3 hours. (source)
- Stroke trial: 50 mL: 50 mL once daily once daily, into a vein. Studied in a trial. Studied in: Acute stroke within 24 hours. (source)
- CARS: 30 mL with rehabilitation: 30 mL once daily once daily, into a vein. Studied in a trial. Studied in: Stroke rehabilitation starting 24–72 hours after onset. (source)
- Subacute stroke: 30 mL: 30 mL once daily once daily, into a vein. Studied in a trial. Studied in: Motor impairment; treatment on stroke days 8–28. (source)
- Extended rehabilitation: 30 mL: 30 mL once daily once daily, into a vein. Studied in a trial. Studied in: Severe arm impairment around 10 days after stroke. (source)
Highest studied: 10 mL/day IM is the highest verified human exposure located, in a small retrospective cohort..
These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.
How to store Cerebrolysin
Comes as: Licensed amber liquid in glass ampoules or vials; 215.2 mg peptide fraction per mL, Austrian pack sizes: 1, 2, 5, 10, 20, 30 and 50 mL; availability varies.
Mixed with: Already liquid. Austria lists 0.9% saline, Ringer solution or 5% glucose for IV dilution. No powder mixing is needed..
- National prescribing information is represented as clinical-practice here; the schema reserves label for FDA/EMA.
- Ampoules have 48-month shelf life; 20, 30 and 50 mL puncturable vials have 24 months, when stored as specified.
- Austrian limits: up to 5 mL IM, up to 10 mL IV; infusion recommended from 10 mL, over about 15–60 minutes.
- Use only clear amber solution. Sodium hydroxide and water for injection are listed excipients.
- Milligram-labeled powder has no established conversion to the licensed liquid; 215.2 mg/mL does not establish product equivalence.
- This field does not validate community powder mixing or nasal-spray storage.
Before mixing: Austrian national SmPC: below 25°C, protected from light in the original pack. Do not refrigerate or freeze.
After mixing: Single withdrawal only; discard leftovers immediately. Tested 24-hour compatibility does not establish safe storage after opening.
Cerebrolysin side effects and risks
Reported side effects
- Serious nonfatal harms after acute stroke: Cochrane: 20/667 (3.0%) versus 8/668 (1.2%); RR 2.39, 95% CI 1.10–5.23., serious (source)
- Headache: CARS 1: 6/104 (5.8%) versus 3/104 (2.9%) placebo., mild (source)
- Insomnia: CARS 1: 6/104 (5.8%) versus 4/104 (3.8%) placebo., moderate (source)
- Severe allergy or shock: Austrian label: <1/10,000; a life threatening case is published., serious. Stop administration and get emergency care. (source)
- Seizure: Austrian label: <1/10,000. A TBI cohort reported more seizures; exact rates unavailable., serious. Stop and seek urgent care for a new seizure. (source)
- Stomach upset, nausea, diarrhea or constipation: Austrian label: <1/10,000. Label rates differ from all cause trial event rates., mild (source)
- Agitation, confusion or poor sleep: Austrian label: 1/10,000 to <1/1,000., moderate (source)
- Warmth, sweating, itching or dizziness: Austrian label: 1/10,000 to <1/1,000; rapid administration can contribute., mild (source)
- Palpitations or irregular heartbeat: Austrian label: <1/10,000, especially with rapid administration., serious (source)
- Injection-site redness, itching or burning: Austrian label: <1/10,000; community injection pain rates are unknown., mild (source)
- Brain fog, mood changes or flu-like feelings: Community reports; no reliable rate or proven cause., moderate (source)
Stop and get help if
- Trouble breathing, swollen lips or tongue, collapse or widespread hives: Stop administration and call emergency services now.
- New seizure, repeated seizures or not waking normally: Get emergency care now; protect from injury and give no further doses.
- New one-sided weakness, speech loss, sudden severe headache or reduced consciousness: Call emergency services; do not delay stroke care for a peptide dose.
- Chest pain, fainting or sustained irregular heartbeat: Stop administration and seek urgent medical assessment.
- Hot spreading injection-site redness, pus, fever or shaking chills: Seek urgent assessment for infection; retain product and batch details.
Who should avoid it
- pregnant: Human safety is unestablished. Austria allows only necessary clinical treatment.
- breastfeeding: Milk transfer and infant safety are unknown. Austria requires choosing between nursing and treatment.
- tryingToConceive: Precaution: human fertility safety and a preconception stopping interval are unknown.
- under18: Adults-only reference. Austria does not recommend use under 18 because data are insufficient.
- other: An ongoing or repeated seizure emergency is an Austrian label contraindication. Seek emergency care.
- seizureDisorder: Seizure frequency may rise. Some regional labels are stricter; review epilepsy or past post-traumatic seizures.
- other: Severe kidney impairment is an Austrian label contraindication. A safe adjusted dose is unestablished.
- kidneyDisease: Kidney severity must be checked; severe impairment is contraindicated.
- other: Prior hypersensitivity is contraindicated; life-threatening anaphylaxis has been reported.
- other: The Austrian label advises caution with an allergic tendency.
- activeCancer: Precaution: an Alzheimer trial reported IGF-I changes. Active-cancer safety is unknown; this is not a label contraindication.
- heartCondition: Rapid administration can cause palpitations or rhythm changes; review before exposure.
- uncontrolledBloodPressure: High-dose MAO inhibitors with 30–40 mL Cerebrolysin can raise blood pressure.
- psychiatricCondition: Agitation, confusion and insomnia are reported. Unstable mood conditions need review.
- bleedingDisorder: Muscle injection may cause bleeding or a hematoma; assess the route and bleeding risk.
- testedAthlete: No named WADA ruling found. IV volume rules apply even when a drug is not named.
Interactions
- MAO inhibitors: Additive effects; high-dose MAO inhibitors with 30–40 mL Cerebrolysin can raise blood pressure.
- Other antidepressants: Austria warns of additive effects and suggests clinician-led antidepressant dose review. Do not change antidepressants independently.
- Balanced amino-acid infusions: Do not mix in the same infusion; the Austrian label identifies an incompatibility.
- Lipid infusions or same-syringe medicines: Lipid-containing or pH-changing solutions are incompatible. Vitamins and heart medicines should not share the same syringe.
- Blood thinners and antiplatelet drugs: Muscle injections may cause bleeding or bruising. This is a route precaution, not a proven Cerebrolysin drug interaction.
- Donepezil: A randomized combination trial found no significant added cognitive benefit; clinician-managed use was studied.
- Other neuroactive peptide mixtures: Self-use combinations lack controlled human safety evidence. Other brain-derived preparations are not interchangeable.
Product quality risks
- One chemical study identified 638 peptides in an online sample. It did not establish sterility, dose consistency or market-wide authenticity.
- A lab comparison found other mixtures had different composition and activity. It was not a counterfeit-prevalence survey.
- Unregulated injections may be mislabeled, contaminated or nonsterile. No representative Cerebrolysin online-market purity survey was found.
- A powder sold under this name is not established as equivalent to the licensed liquid.
What to expect
National approvals exist, but no FDA approval. Stroke survival benefit is unproven; brain-injury trials are small, and at least 43 human studies were identified.
Key studies
- CASTA: acute stroke: The largest acute-stroke trial missed its primary endpoint. (source)
- CERE-LYSE-1: with alteplase: Early neurological gains did not become a day-90 disability benefit. (source)
- Stroke: 50 mL for 21 days: Main neurological and daily-function outcomes were neutral. (source)
- Stroke dose finding: 10 or 50 mL: A tiny dose-finding study reported MRI changes. (source)
- CARS-1: rehabilitation: Arm recovery favored Cerebrolysin in this exploratory trial. (source)
- CARS-2: replication: The replication contributes to pooled evidence but has limited standalone reporting. (source)
Cerebrolysin FAQ
- Is Cerebrolysin FDA-approved? No FDA-approved product or label found. FDA’s 2020 warning specifically names Cerebrolysin; research labeling does not establish approval.
- How do people take it? Into a vein, once daily. Source: clinician-published.
- What's the difference between Cerebrolysin and Semax? Cerebrolysin: an injectable pig brain mixture with mixed stroke, brain-injury and dementia evidence. Semax: a Russian nasal peptide with limited human evidence for brain and nerve effects. Why people pair them: users alternate or combine cycles seeking recovery and focus; no controlled human combination trial was verified.
- Can I take it with Semax? Users alternate or combine cycles seeking recovery and focus; no controlled human combination trial was verified. Benefits and adverse reactions are hard to attribute. Synergy is unproven. Source: reported by users. Ask a doctor before combining anything.
- Is it banned in sport? It is unclear (WADA 2026). Foreign approval means S0 is not automatic. IV totals >100 mL/12 hours are prohibited outside listed medical exceptions; no compound-specific ruling found. M2.2 separately addresses total IV infusions or injections over 100 mL per 12 hours, except legitimate hospital treatment, surgical procedures or clinical diagnostic investigations.
- How do I store it once opened? Single withdrawal only; discard leftovers immediately. Tested 24-hour compatibility does not establish safe storage after opening.
Related to Cerebrolysin
- Semax: A Russian nasal peptide with limited human evidence for brain and nerve effects.
- Selank: A Russian nasal anxiety peptide with uncertain long-term benefit and safety.
- PE-22-28: An experimental mood peptide studied in mice, with no human trials found.
- Dihexa: An experimental memory compound with disputed animal research and no established human dose.
- P21: An experimental memory peptide with animal research and no established human dose or safety profile.
- BPC-157: An experimental repair peptide with mostly animal evidence and a few small human reports.
Sources
- 21 CFR 216.23 — Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act., Office of the Federal Register · eCFR · 2026
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2026
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
- MHRA Products | Home, MHRA · MHRA · 2026
- TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response, Therapeutic Goods Administration · TGA · 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
- Using intramuscular injections in people on oral anticoagulants, NHS Specialist Pharmacy Service · NHS Specialist Pharmacy Service · 2023
- European Academy of Neurology and European Federation of Neurorehabilitation Societies guideline on pharmacological support in early motor rehabilitation after acute ischaemic stroke., Beghi E et al. · European journal of neurology · 2021
- Tailor Made Compounding LLC - 594743 - 04/01/2020, FDA · FDA · 2020
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, FDA · FDA · 2000
- CEREBROLYSIN, BASG
- Drug Product Database online query, Health Canada
- PHARMACY & POISONS BOARD OF HONG KONG | 香港藥劑業及毒藥管理局, Hong Kong Department of Health
Sources checked: 2026-10-18.
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