Competition in the weight loss market is heating up. The two leaders, Eli Lilly (LLY 2.22%) and Novo Nordisk (NVO 1.75%), have robust pipelines, with several candidates recently approved or expected to be approved soon. One of them for Eli Lilly is orforglipron, an oral GLP-1 medicine. Although orforglipron looks promising, it recently experienced a setback that sent Eli Lilly's shares down by about 4% in one day. Was the market's reaction justified? Let's find out.
A longer review time
After it aced phase 3 studies last year, Eli Lilly requested approval from the U.S. Food and Drug Administration (FDA) for orforglipron in December. The agency granted the medicine a new voucher that allows for a one- to two-month review time, much shorter than the usual 10 to 12 months. So, orforglipron should earn approval by the end of February, or that was the original plan. The FDA recently announced that it was extending the review time and now expects to decide on whether to approve orforglipron by April 10.
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There's one crucial reason why this matters. Novo Nordisk earned approval for the oral version of Wegovy in December and has already launched it. Oral GLP-1 drugs could reach patients who are harder to attract with the weight loss options that have been on the market for several years now, which are administered subcutaneously. Some dislike needles, and others, perhaps because they are constantly traveling, have issues accepting the cold storage requirements of subcutaneous injections.
Oral pills address these problems. And now, Novo Nordisk will have even more time to capture a large portion of this market before Eli Lilly can launch its own challenger.
NYSE: LLY
Key Data Points
Should you give up on Eli Lilly?
It is worth remembering that the original version of Wegovy was approved in 2021, over two years before Eli Lilly's Zepbound. Yet, as of the third quarter of 2025, Zepbound was generating higher sales. A first-mover advantage matters in this market, but other factors such as efficacy, safety, tolerability, and breadth of application are even more important.
Oral Wegovy may have been the first oral GLP-1 approved for weight loss, but orforglipron showed competitive efficacy, especially in patients with diabetes who have a harder time losing weight. Further, besides orforglipron, Eli Lilly has an attractive mid- and late-stage pipeline in its core therapeutic area, and that's before we move beyond it and look at the company's work elsewhere.
Financial results remain strong, the company's prospects are attractive thanks to its leadership in the rapidly growing weight loss market, and the stock offers other perks, such as a robust dividend program. The market may have overreacted to the FDA taking an extra month or so to review orforglipron's data. The company's shares remain a buy.
