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Novo Nordisk (NYSE:NVO) has filed for U.S. approval of an oral version of its blockbuster weight loss drug Wegovy, the company confirmed to BioPharma Dive. The Danish drugmaker disclosed the submission two years after reporting positive Phase 3 trial data showing the pill helped patients lose up to 15% of their body weight over 64 weeks.
The medication is an oral form of semaglutide, the same active ingredient in Wegovy and Ozempic, Novo’s high-profile injectable drugs for obesity and diabetes. Although the company originally published trial results in 2023, it delayed filing while focusing on next-generation obesity therapies.
The move comes amid growing competition in the obesity treatment market, particularly with Eli Lilly (NYSE:LLY), which announced last week that its oral GLP-1 candidate, orforglipron, met criteria in a diabetes trial. Lilly plans to seek regulatory approval if a parallel obesity study proves similarly effective.
The Wegovy pill would offer an alternative to injectable treatments at a time of skyrocketing demand for weight-loss drugs. If approved, the pill could offer a more accessible alternative to injectable treatments, as Novo and Eli Lilly compete to broaden their markets in a fast-growing obesity drug sector.
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