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a separate treatment-use formulation (0.5 mg and 1.0 mg base per vial, for treating growth hormone deficiency and growth failure in children) was approved September 26, 1997 under NDA 20-443

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Cerebrolysin's Position: Decades of clinical use across 40+ countries with established safety and efficacy data Meta-analyses and Cochrane systematic reviews the highest levels of clinical evidence Known limitations: complex mixture makes precise mechanism attribution difficult, not FDA-approved, requires IV/IM administration Represents validated but incrementally effective neurotrophic therapy Dihexa's Position: Exceptional mechanistic novelty HGF/c-Met potentiation at picomolar concentrations is a genuinely unique pharmacological finding if confirmed Entirely preclinical with no human data of any kind Foundational research compromised by expression of concern and retraction the core evidence base is actively questioned Theoretical safety concerns (c-Met oncogenesis) that have not been addressed experimentally Represents frontier neuroscience that has not survived the basic tests of scientific reproducibility For Researchers: Cerebrolysin offers a clinically validated tool for studying neurotrophic effects in humans, supported by the strongest available evidence

Foundation for Peripheral Neuropathy