The FDA cleared at‑home administration for Delix Therapeutics’ next Phase‑2 study of a non‑hallucinogenic 'neuroplastogen' being developed for depression. Delix reported promising early clinical signals and said regulators agreed that the compound’s safety profile supports outpatient dosing in the forthcoming study. The decision is notable because psychedelics and related therapies typically require clinic‑based administration and monitoring due to acute psychoactive effects. Delix’s candidate is engineered to retain rapid synaptic plasticity‑promoting properties without inducing hallucinations, enabling simpler trial logistics and broader patient access if efficacy holds. Allowing at‑home dosing could speed enrollment and lower trial costs; regulators will require remote safety monitoring and clear risk‑mitigation procedures. For readers: neuroplastogens aim to stimulate neural circuit remodeling without classic psychedelic subjective effects.
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