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

Eli Lilly The US pharmaceutical company said on Thursday that it will submit an application for approval for the next generation of obesity drugs in the first quarter of 2027, as the treatment succeeds in two other late-stage trials.

The pharmaceutical giant previously said it would place an order early this year for the weekly injection, retaretide, 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 collect and verify manufacturing and quality control data required by regulators before it can receive approval.

In two separate phase III trials, retaretide achieved 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 cardiovascular disease.

Based on the data, the company believes it has the information necessary to apply for global approval of retardetrate as a potential treatment for obesity, knee osteoarthritis pain and obstructive sleep apnea, Kenneth Caster, president of Lilly Cardiometabolic Health, said in a statement.

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

In another trial, adults with severe obesity and cardiovascular disease, with or without diabetes, during treatment lost up to 22.6% of their weight, or 55.8 pounds, in 80 weeks. Lilly added that retatrotide significantly reduced some cardiovascular risk factors in patients.

The side effects associated with the drug were consistent across the two trials as well as previous studies on the treatment. The most common are 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 retatrotide, which Lilly is positioning as the next pillar of its obesity portfolio following its Zepbound injection and its newly launched pill, Foundayo. In a January note, TD Cowen analysts estimated that retaretide could generate $3.8 billion in sales in 2030.

Retatrutide is also crucial to the drugmaker’s plan to maintain a majority market share over Novo Nordisk in the booming market for weight loss and diabetes drugs. Some analysts estimate that this sector could be worth about $100 billion by the 2030s.

Retatrotide, called Triple G, targets GLP-1, GIP and glucagon instead of just one or two of those hormones like existing treatments. This appears to have stronger effects on a person’s appetite and food satisfaction than other treatments.

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