U.S. pharmaceutical giant Eli Lilly (LLY) says that it plans to submit its experimental weight-loss pill called Orforglipron for regulatory approval in several different markets at the same time.
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Eli Lilly said that it will apply for regulatory approval for the weight-loss pill in multiple markets around the world “within weeks” of each other as it seeks to launch the new medication in summer 2026. “We are submitting to most of the major regulatory bodies pretty much at the same time,” said the company in a new report.
Specifically, Eli Lilly plans to file applications with regulators in the U.S., United Kingdom (U.K.), European Union (EU), Japan, and China in a coordinated approach. The company is also considering making regulatory submissions in the United Arab Emirates (UAE) and Saudi Arabia.
Regulatory approvals in different jurisdictions around the same time will help Eli Lilly expand its share of the weight-loss drug market, say analysts.
Latest Trial Results
News of the approach on regulatory approvals comes as Eli Lilly announces that its weight-loss pill outperformed rival Novo Nordisk’s (NVO) oral drug in the first head-to-head study comparing the two medications in patients with Type 2 diabetes.
Eli Lilly said its pill, Orforglipron, was superior at lowering blood sugar levels at 52 weeks compared to Novo Nordisk’s weight-loss pill candidate called Semaglutide. It should be noted that there is currently no data comparing Eli Lilly’s weight-loss pill against Novo Nordisk’s pill in patients with obesity.
Is LLY Stock a Buy?
The stock of Eli Lilly has a consensus Strong Buy rating among 21 Wall Street analysts. That rating is based on 17 Buy and four Hold recommendations issued in the last three months. The average LLY price target of $908.71 implies 20.47% upside from current levels.
