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SAP-021-T1 is an investigational, novel oral solid-dose (capsule) formulation of synthetic cannabidiol (CBD) developed by Avata Biosciences (formerly Sapient Therapeutics). It is one of two candidate formulations (alongside SAP-021-T2) designed to improve the pharmacokinetic profile and bioavailability of cannabidiol compared to existing oil-based solutions like Epidiolex. The drug is being developed via the FDA's 505(b)(2) regulatory pathway, leveraging the established safety and efficacy data of cannabidiol for the treatment of epilepsy-related seizure disorders, including Dravet syndrome and other treatment-resistant epilepsies. SAP-021-T1 has been evaluated in Phase 1 clinical trials to assess its relative bioavailability and the impact of food on its absorption in healthy volunteers.
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