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Cerebrolysin

Neurotrophic

Also known as: FPF-1070, porcine brain peptide preparation

Tier 3, Preclinical only

Evidence is limited to animal or in-vitro work. No human pharmacokinetics. Any human dose in circulation is extrapolated, and extrapolation across species routinely fails.

Half-life
Not established · human data · intravenous

Cerebrolysin is NOT a single molecule, it is a porcine-brain-derived mixture of low-molecular-weight peptides (<10 kDa, ~25% peptides by nitrogen content) plus free amino acids, given IV/IM. A single half-life does not meaningfully apply. The commonly-repeated '3-4 h half-life' is a vendor figure and could NOT be traced to a primary PK study; flagged unverified. Clinical trials note functional benefit persists to day 90 long after plasma clearance, consistent with a trophic (not classical-PK) effect.

Dosing
No established dose

Dosed as milliliters of solution (typically 10-30 mL IV daily in stroke trials such as CARS), NOT in micrograms of a defined active, so mcg low/high are not applicable. See trial sources for mL regimens.

Frequency
In trials: once-daily IV infusion for ~10-21 consecutive days per course (per cited RCTs).
Regulatory status
Approved/registered in numerous countries including Russia, China, and parts of Europe/Asia (manufacturer Ever Pharma). NOT FDA-approved and not EMA centrally approved.
Evidence base
mixed · confidence: medium

Large but heterogeneous RCT base for acute ischemic stroke and vascular dementia; meta-analyses (e.g. 14-RCT pooled analysis) suggest benefit in more severe/early stroke but effect sizes are modest and some trials are industry-sponsored. A Cochrane-type view has flagged risk of bias. Mixed, not definitive.

Storage

Reconstituted: Supplied as a sterile aqueous ampoule/solution; store per manufacturer label (protect from light). Not a lyophilized research powder.

Safety

Porcine-derived biological, theoretical immunogenicity/allergy risk. Given parenterally in medical settings. Composition is not fully chemically defined; batch variability possible.