Eli Lilly Delays Next-Generation Obesity Drug Approval Filing to Early 2027 After Successful Trials

Eli Lilly on Thursday said it will file for approval of its next-generation obesity drug in the first quarter of 2027, as the treatment succeeds in two more late-stage trials.

The pharmaceutical giant previously said it would submit an application as early as this year for the weekly injection, retatrutide, which works differently and appears to be more effective than existing shots and pills. In a statement to CNBC, Lilly said it needs more time to gather and verify the manufacturing and quality-control data required by regulators before it can seek approval.

In two separate Phase 3 trials, retatrutide delivered significant weight loss and improvements in a key measure of blood sugar levels in adults with obesity and two major complications, Type 2 diabetes and established cardiovascular disease.

Based on the data, the company believes it has the information necessary to file for approval globally for retatrutide as a potential treatment for obesity, knee osteoarthritis pain and obstructive sleep apnea, Kenneth Custer, president of Lilly Cardiometabolic Health, said in a release.

In one trial, adults with obesity and diabetes taking the drug lost up to an average of 20.8% of their weight, or nearly 50 pounds, at 80 weeks. That population typically struggles to lose weight.

In another trial, adults with severe obesity and established cardiovascular disease, with or without diabetes, on the treatment lost up to an average of 22.6% of their weight, or 55.8 pounds, at 80 weeks. Retatrutide meaningfully reduced certain cardiovascular risk factors in patients, Lilly added.

The side effects associated with the drug were consistent across the two trials as well as previous studies on the treatment. The most common included diarrhea, nausea and constipation, which are also seen across the broader GLP-1 class.

There are now positive results from five late-stage trials on retatrutide, which Lilly is positioning as the next pillar of its obesity portfolio after its injection Zepbound and newly launched pill, Foundayo. In a January note, TD Cowen analysts estimated that retatrutide could rake in sales of $3.8 billion in 2030.

Retatrutide is also critical to the drugmaker's plan to maintain its market share majority over Novo Nordisk in the booming market for weight loss and diabetes drugs. Some analysts estimate the segment could be worth about $100 billion by the 2030s.

Dubbed the "triple G" drug, retatrutide targets GLP-1, GIP and glucagon rather than just one or two of those hormones like existing treatments. That appears to have more potent effects on a person's appetite and satisfaction with food than other treatments.

Tirzepatide, the active ingredient in Zepbound, mimics GLP-1 and GIP. Novo Nordisk's semaglutide, the active ingredient in Wegovy, mimics only GLP-1.