SEP-479

SEP-479 is an orally bioavailable, small molecule agonist of the Thyroid Stimulating Hormone Receptor (TSHR), developed by Septerna, Inc. using its proprietary Native Complex™ platform. The drug is designed to treat hypothyroidism by directly stimulating the TSH receptor on the thyroid gland, mimicking the natural action of thyroid-stimulating hormone to promote the production of endogenous thyroid hormones (T3 and T4). This mechanism represents a potential shift from traditional hormone replacement therapy (levothyroxine), aiming to provide a more physiological and comprehensive treatment for patients, including those who remain symptomatic despite standard care. SEP-479 is currently undergoing Phase 1 clinical evaluation to assess its safety, tolerability, and pharmacokinetics in healthy volunteers.