Eli Lilly to file retatrutide for regulatory approval in Q1 2027

The Eli Lilly logo appears on the company's office in San Diego, California, Nov. 21, 2025. Mike Blake | Reuters

Eli Lilly on Thursday announced it will file for approval of its next-generation obesity drug, retatrutide, in the first quarter of 2027, following success in two additional late-stage trials.

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

Trial Results

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.

• Trial 1: Adults with obesity and diabetes taking the drug lost up to an average of 20.8% of their weight (nearly 50 pounds) at 80 weeks. This population typically struggles to lose weight.
• Trial 2: 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 (55.8 pounds) at 80 weeks. Retatrutide also meaningfully reduced certain cardiovascular risk factors, Lilly added.

Regulatory Path and Portfolio Strategy

Based on the data, the company believes it has sufficient evidence to file for global approval of retatrutide as a potential treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnea, according to Kenneth Custer, president of Lilly Cardiometabolic Health.

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 generate sales of $3.8 billion in 2030.

Market Context

Retatrutide is critical to Lilly's strategy to maintain its market share majority over Novo Nordisk in the booming weight loss and diabetes drug market. Some analysts estimate the segment could be worth approximately $100 billion by the 2030s.

Side Effects

The side effects associated with retatrutide were consistent across both trials and with previous studies. The most common included diarrhea, nausea, and constipation — effects also seen across the broader GLP-1 class.

Mechanism of Action

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

For comparison:

• Tirzepatide (active ingredient in Zepbound) mimics GLP-1 and GIP.
• Semaglutide (active ingredient in Novo Nordisk's Wegovy) mimics only GLP-1.

Choose CNBC as your preferred source on Google and never miss a moment from the most trusted name in business news.