Eli Lilly will file for approval of retatrutide obesity drug in 2027

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

The pharmaceutical giant had previously said it would apply earlier this year for the weekly injection of retatrutide, which works differently and appears to be more effective than existing vaccines and pills. In a statement to CNBC, Lilly said it needed more time to collect and verify manufacturing and quality control data needed by regulators before receiving approval.

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

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

In one trial, adults with obesity and diabetes who took the drug lost an average of 20.8% of their weight, or about 50 pounds, in 80 weeks. This population often has difficulty losing weight.

In another study, adults with severe obesity and cardiovascular disease with or without diabetes lost an average of 22.6% of their weight, or 55.8 pounds, over 80 weeks during treatment. Lilly added that Retatrutide significantly reduced certain cardiovascular risk factors in patients.

Drug-related side effects were consistent across the two trials and in previous studies of the treatment. The most common included diarrhea, nausea, and constipation, which are also seen in the broader GLP-1 class.

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

Retatrutide is also critical to the drugmaker’s plan to retain majority market share against Novo Nordisk in the fast-growing market for weight-loss and diabetes drugs. Some analysts estimate the segment could be worth nearly $100 billion by the 2030s.

Retatrutide, called a “triple G” drug, targets GLP-1, GIP, and glucagon rather than just one or two of these hormones like current treatments. This appears to have stronger effects on a person’s appetite and satisfaction with eating than other treatments.

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