The FDA cleared at-home administration for Delix Therapeutics’ non‑hallucinogenic neuroplastogen in an upcoming Phase II depression study, allowing patients to self‑dose outside clinic settings. Delix also reported encouraging early-stage data suggesting its candidate may produce antidepressant effects without psychedelic experiences. Regulators’ willingness to permit at-home dosing for a psychedelic‑like but non‑hallucinogenic molecule marks a notable shift in trial logistics, potentially lowering cost and increasing enrollment speed for future psychiatric programs. Delix plans to leverage the clearance to design decentralized elements into the pivotal program.
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