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NTI164 is a proprietary, orally administered, full-spectrum medicinal cannabis extract developed by Neurotech International and Fenix Innovation Group. [1, 5] It is derived from a unique strain of Cannabis sativa, characterized by a very low concentration of tetrahydrocannabinol (THC, <0.3%) and high levels of cannabidiolic acid (CBDA), along with a combination of other minor cannabinoids such as CBG, CBN, CBC, and CBDP. [1, 16] The proposed mechanism of action involves potent anti-inflammatory, neuroprotective, and neuro-modulatory activities, attributed to the synergistic interaction of its components (the 'entourage effect'). [1, 16] NTI164 is being developed as a treatment for pediatric neurological disorders where neuroinflammation is believed to play a role. [1] It has shown positive results in clinical trials for Autism Spectrum Disorder (ASD), Rett Syndrome, and Pediatric Acute-onset Neuropsychiatric Syndrome (PANS). [3, 8] The U.S. FDA has granted NTI164 both Orphan Drug Designation and Rare Pediatric Disease Designation for the treatment of Rett Syndrome. [9]
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