Cerebrolysin research: studies, doses and safety
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.
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)
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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