April 24, 2025
Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss drug in obesity earlier this year, a spokesperson confirmed.
The company first reported in 2023 that the drug, an oral form of semaglutide, succeeded in a Phase 3 trial, helping people on the highest dose lose about 15% of their body weight after 64 weeks. However, the Danish drug firm didn’t seek approval immediately afterwards, instead focusing attention on other medicines that might improve upon the injectable drug it sells as Wegovy for obesity and Ozempic for diabetes.
The approval filing comes as a race with rival Eli Lilly to develop a weight loss pill has intensified. Lilly last week said its oral GLP-1 pill succeeded in a large trial in diabetes. That drug, orforglipron, could be submitted to regulators if an ongoing study in obesity also meets its objectives.
Novo has long appeared to be well ahead of others in that race. It had already developed Rybelsus, an oral formulation of semaglutide, for diabetes, and began testing a higher-dose version of it in obesity. And in May 2023, it reported success in a study that tested as high as a 50 milligram oral dose of semaglutide.
Novo’s executive team will provide more details about the approval application alongside the company’s first quarter earnings report on May 7.
Commentary
If Novo does indeed gain approval for a weight loss pill, this would be a game changer. Such a pill would be cheaper than current injectable drugs and consumers that are now hesitant to take injections would likely embrace a pill wholeheartedly. This would broaden the market substantially.
Learn More About The Market for Medical Weight Loss Programs
Marketdata LLC has published anew 154-page analysis of the U.S. weight loss market, entitled: “The U.S. Medical Weight Loss Market: The Impact of GLP-1 Drugs on Doctors, Hospitals, Clinics and Franchises”, February 2025. This report presents a complete picture of the medical weight loss market in the United States, with the inter-relationships between competing MDs, clinics, surgeons, commercial weight loss companies and pharmaceutical firms.
At no other time in the U.S. weight loss market history has one product so dominated the market as have the new GLP-1 weight loss drugs. American dieters have flocked to them, shunning commercial weight loss programs such as Weight Watchers, Medifast, as well as retail and MLM meal replacements.
Demand soared in 2023 and 2024 for Ozempic, Wegovy, Saxenda, Mounjaro and Zepbound — with more new drugs coming in the next few years.
The booming market for GLP-1 drugs has attracted physicians, nurses, dieticians, telemedicine services, medical weight loss franchises, compounding pharmacies, and entrepreneurs – all looking to cash in. However, the party may soon be over for the compounders, as the FDA declared and end to the shortage of the major drugs.
Some Report Findings:
- The value of the U.S. medical weight loss market is estimated to have more than tripled since 2019, to $33.8 billion in 2024. Average annual growth of 12% is forecast through 2028.
- The prescription obesity drugs market soared from $5.0 billion in 2022 to $26.4 billion by 2024, due to the high demand for new GLP-1 drugs. More than 8% of Americans are now estimated to be using them.
- The number of weight loss surgeries has declined 25% since 2022, to 211,000 procedures, as Americans opted for the new drugs instead. This market segment is worth $5.29 billion.
- Hospitals have had a mixed record with weight loss programs. Only 29% of the nation’s hospitals (about 1,400) provide some form of weight loss program – surgery or a non-surgical program.
- Medical weight loss programs represented 11.7% of the total U.S. weight loss market in 2022, but this share is forecast to triple to 36% by 2028.
- Prescription weight loss drugs have stolen major market share from commercial weight loss companies, the meal replacements market, health clubs, the bariatric surgery market, and more.
- The top 11 medical weight loss franchises and regional chains are estimated to generate $264 million in system-wide sales annually. Most franchises are not growing.
Purchase This Report
The report may be purchased at the Marketdata website’s store. Price: $1,495. Or call: 813-971-8080. Table of Contents available, see home page, link for Diet Market – Our Specialty.