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Laboratory and Metabolic Parameters Clinical trials have monitored various metabolic and safety parameters [9] : Contraindications & Precautions Research Protocol Exclusion Criteria (from clinical trials) History of pancreatitis (acute or chronic) Pre-existing gastroparesis or severe gastrointestinal disease Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) History of diabetic ketoacidosis Severe renal impairment (eGFR 99% as verified by High-Performance Liquid Chromatography (HPLC) Third-Party Testing: Independent laboratory verification with Certificate of Analysis (COA) included Lyophilized Form: Stable powder format for extended shelf life and easy reconstitution Proper Storage: Maintained at -20C to preserve peptide integrity USA Manufactured: Produced in domestic facilities following Good Manufacturing Practices (GMP) [18]

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Dihexa (PNB-0408, Hexanoyl-Tyr-Ile-Ahx-NH2) is an oligopeptide drug, orally active and blood-brain barrier-permeable angiotensin IV analog, binds to hepatocyte growth factor (HGF) with high affinity (Kd=65 pM) and potentiates its activity at its receptor c-Met