Eli Lilly expands early access to experimental weight loss drug retatrutide

Eli Lilly confirmed Monday it will allow patients to apply for early access to retatrutide, its unapproved weight loss drug, expanding a program previously limited to a single patient. The company said it will review physician requests for patients who meet specific medical criteria and cannot enroll in clinical trials, consistent with FDA guidance. This follows STAT reporting that multiple doctors had received no response from Lilly when seeking expanded access. Retatrutide targets three hormonal pathways, surpassing existing drugs like Zepbound and Wegovy. Lilly plans to file for regulatory approval in early 2027, citing manufacturing data needs, after late-stage trials showed up to 28.3% average weight loss.