Rezolute, Inc. (NASDAQ: RZLT) is a clinical-stage biopharmaceutical company focused on developing innovative therapies for endocrine and metabolic disorders with significant unmet medical needs. The company’s lead candidate, RZ358, is an investigational monoclonal antibody designed to modulate insulin receptor activity and normalize aberrant insulin signaling in conditions such as congenital hyperinsulinism. Rezolute’s pipeline also includes RZ402, a novel long-acting basal insulin analog engineered to provide stable glycemic control while minimizing the risk of hypoglycemia in patients with type 1 and type 2 diabetes.
Founded in 2015 and headquartered in San Diego, California, Rezolute has built a proprietary research platform that integrates advanced antibody engineering, peptide formulation, and translational pharmacology. This platform underpins early-stage programs targeting hormonal pathways implicated in rare endocrine diseases and inflammatory metabolic conditions. By leveraging precise molecular design and biomarker-driven strategies, the company aims to accelerate the development of first-in-class and best-in-class therapeutics.
Rezolute collaborates with leading academic institutions and contract research organizations across North America and Europe to support its preclinical and clinical activities. Its clinical trials are structured to yield robust mechanistic insights and facilitate regulatory engagement, reflecting a commitment to evidence-based, patient-centric development. The company’s global strategy includes expanding trial sites and forging partnerships to ensure broad access to its investigational therapies.
Under the leadership of a seasoned management team with deep expertise in biotechnology, endocrinology, and pharmaceutical development, Rezolute maintains a lean operational model focused on scientific rigor and innovation. The company’s multidisciplinary staff spans drug discovery, clinical pharmacology, and regulatory affairs, positioning Rezolute to address complex hormonal disorders and advance therapeutic options for patients worldwide.
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