Eli Lilly and CompanyPre-approval access expands patient reach for retatrutide, signaling strong demand and potential early adoption.

Eli Lilly will provide a limited number of patients with pre-approval access to its experimental obesity drug retatrutide before U.S. regulatory clearance. A company spokesperson said it is medically appropriate to make authentic retatrutide available before FDA approval, consistent with agency guidance, and that Lilly is reviewing requests from healthcare providers. Eligible patients must be 18 or older, have refractory obesity despite tolerating the highest approved dose of existing obesity therapy, and have at least two serious or life-threatening obesity-related complications for which they are receiving care, while also being unable to enroll in an ongoing trial of retatrutide or a comparable investigational treatment. Retatrutide targets three metabolic hormones—GLP-1, GIP, and glucagon—compared with two for Lilly’s current injectable obesity drug Zepbound. In July, the company reported that an 80-week trial in adults with severe obesity and established heart disease produced average weight loss of 22.6% at the highest weekly dose, and Lilly plans to file for approval in the first quarter of next year.
Eli Lilly and CompanyPre-approval access expands patient reach for retatrutide, signaling strong demand and potential early adoption.