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ORE-001 is an oral small molecule formulation of lidocaine hydrochloride monohydrate, a well-established amide-type local anesthetic and antiarrhythmic agent, being repurposed by Orexa B.V. The drug functions as a sodium channel modulator that affects gastrointestinal signaling pathways to influence satiety and food intake. It is currently being investigated in Phase 2 clinical trials for two primary indications: the prevention of post-operative ileus (POI) in patients undergoing major abdominal surgery and the treatment of underweight older adults (aged 65–85) to increase food intake, reduce satiety, and promote weight gain. Interim data has suggested that ORE-001 can significantly improve post-operative food intake and accelerate the return of gastrointestinal function compared to placebo.
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