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Jun 23, 2025  |  
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Gabrielle M. Etzel


NextImg:Novo Nordisk applies for FDA approval in tightening race for weight loss pill

Novo Nordisk, the Danish maker of Ozempic and Wegovy, announced Tuesday that it has asked the Food and Drug Administration to approve an oral version of its anti-obesity medication, moving ahead in the race between drugmakers to offer a weight loss pill.

The move comes less than a week after Novo’s largest rival, American company Eli Lilly, announced successful clinical trial results for its new oral diabetes medication, which also had significant weight loss effects as a secondary goal. 

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Eli Lilly and Novo dominate the weight-loss and diabetes markets as the groundbreakers in the development of the GLP-1 drug class, each producing an injectable medication that mimics human hormones to suppress appetite. 

With the rapid success of GLP-1s, many companies, including Eli Lilly and Novo, have been competing for months to create a pill version of the diabetes and weight loss drug that would be more convenient for patients and easier to store and transport. 

Last Thursday, Eli Lilly announced that its pill version, orforglipron, achieved its goal for Type 2 diabetes management as well as the secondary goal of weight loss. In the stage three clinical trial, the drug helped patients lose nearly 8% of their total body weight. 

Lilly is expected to apply for FDA approval for an oral diabetes medication within the year and will likely apply to market the medication as a weight loss drug shortly thereafter. 

After Lilly’s announcement last week, Novo’s stock price plummeted, from $63 per share the night before to $57 per share the morning of Lilly’s announcement.

An hour after the market opened on Tuesday morning, Novo’s price had rebounded by nearly 2.5% following the news of its FDA application. 

Novo currently sells a diabetes management pill, Rybelsus, which was approved by the FDA in 2019. In 2023, Novo announced promising results for its oral weight loss medication, with patients losing 15% of their body weight after 64 weeks. 

At the time, however, Novo was struggling to meet the skyrocketing demand for its injectable weight loss medication, Wegovy, making production capacity for its oral version of the same drug, pending FDA approval, a lower priority. 

Novo’s stock price has fallen by 36% since disappointing clinical trial results for the company’s other oral weight loss medication, CagriSema, were announced last month. 

MICROPLASTICS AND MAHA: HOW RFK JR. CAN REGULATE PLASTICS POLLUTION FROM WITHIN HHS

President Donald Trump’s new FDA Commissioner, former Johns Hopkins University surgeon Dr. Marty Makary, signaled to the biotech sector last week that his leadership will be a boon for biotech innovation. 

During an interview with Megyn Kelly last week, Makary said he would speed up approvals for rare-disease treatments and shorten the industry’s 10-year drug development timeline.