Centessa Pharmaceuticals plc has announced that the U.S. Food and Drug Administration (FDA) has cleared their Investigational New Drug Application $(IND.AU)$ for ORX142, a novel Orexin Receptor 2 (OX2R) agonist. This clearance allows Centessa to initiate a Phase 1 clinical study of ORX142, aimed at treating select neurological and neurodegenerative disorders. The study will focus on acutely sleep-deprived healthy volunteers to assess the safety, tolerability, and pharmacokinetics of the drug. This approval marks a significant milestone for Centessa, as they explore ORX142's potential to address unmet needs beyond rare hypersomnias. The clinical data from this study is expected later this year.
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