The Eli Lilly logo appears at the company's office in San Diego, California, on November 21, 2025.
Mike Blake | Reuters
Eli Lilly On Thursday it said it will apply 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 file an application early this year for the weekly injection, retatrutide, which works differently and appears to be more effective than existing injections and pills. In a statement to CNBC, Lilly said it needs more time to collect and verify the manufacturing and quality control data required by regulators before it can seek approval.
In two separate Phase 3 trials, retatrutide produced 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 apply for global approval of retatrutide as a potential treatment for obesity, knee osteoarthritis pain and obstructive sleep apnea, Kenneth Custer, president of Lilly Cardiometabolic Health, said in a statement.
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. This population usually has difficulty losing weight.
In another trial, adults with severe obesity and established cardiovascular disease, with or without diabetes, who received the treatment lost up to an average of 22.6% of their weight, or 55.8 pounds, at 80 weeks. Retatrutide significantly reduced certain cardiovascular risk factors in patients, Lilly added.
The side effects associated with the drug were consistent in the two trials, as well as in previous studies on the treatment. The most common included diarrhea, nausea and constipation, which are also seen in the broader class of GLP-1.
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 Zepbound shot and recently launched pill, Foundayo. In a January note, TD Cowen analysts estimated that retatrutide could generate sales of $3.8 billion in 2030.
Retatrutide is also critical to the drugmaker's plan to maintain its majority market share over Novo Nordisk in the burgeoning weight loss and diabetes drug market. 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 instead of just one or two of those hormones like existing treatments. It appears to have more powerful 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, uniquely mimics GLP-1.
