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AEVI-004 is a co-crystallised formulation of the racetam nootropic fasoracetam, engineered as a novel drug substance with a higher melting point and improved solid‑state stability compared with the original fasoracetam formulation AEVI-001, while maintaining similar solubility, dissolution, pharmacokinetics, and pharmacology.[5][9][12][13][14] Fasoracetam is an oral non-stimulant pan‑selective activator/modulator of metabotropic glutamate receptors (mGluRs) that crosses the blood–brain barrier, and AEVI-004 is being developed as an oral treatment for attention deficit hyperactivity disorder (ADHD) and related neurodevelopmental indications including autistic disorder and epilepsy, particularly in genetically defined subpopulations with disruptions in the mGluR network.[1][5][9][10][12][14] Originally created by Aevi Genomic Medicine and now under Avalo Therapeutics (formerly Cerecor), AEVI-004 is positioned to leverage existing fasoracetam toxicology to enable streamlined clinical development, with composition-of-matter patent protection projected through 2039.[5][9][14]
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