FDA approves first GLP-1 pill for obesity from Wegovy maker Novo Nordisk

Novo Nordisk’s Groundbreaking Obesity Pill Approved by FDA

The US Food and Drug Administration has given the green light to Novo Nordisk’s revolutionary obesity pill, marking a significant milestone in the treatment of obesity. This approval is expected to increase access to treatment for more patients, as it offers an alternative to injections. The pill, which contains the same active ingredient as Novo Nordisk’s blockbuster weight loss drug Wegovy, works by mimicking the gut hormone GLP-1 to suppress appetite.

Novo Nordisk plans to launch the pill in early 2026, with the starting dose of 1.5 milligrams available in pharmacies and through select telehealth providers for $149 per month. This pricing is in line with the company’s deal with President Donald Trump’s direct-to-consumer website, TrumpRx, which will also offer the pill at the same price when it launches in January. While the cost of higher doses has not been disclosed, Novo Nordisk has assured that additional information on coverage and savings options will be available soon.

Market Impact and Competition

The approval of Novo Nordisk’s pill gives the company a head start over its main competitor, Eli Lilly, which is currently the dominant player in the market. Eli Lilly is racing to launch its own obesity pill, and the market is expected to be highly competitive. Analysts predict that the GLP-1 market could be worth around $100 billion by the 2030s, with pills capturing a significant share of the market. Goldman Sachs analyst estimates that pills could capture a 24% share of the global weight loss drug market by 2030, valued at around $22 billion.

Novo Nordisk’s executive vice president of US operations, Dave Moore, expressed excitement about the approval, stating that the oral option will “activate and motivate different segments to seek treatment.” He emphasized that patients will have the comfort and familiarity of the same active ingredient as Wegovy, which has a proven safety and efficacy record. Moore also noted that the pill’s pricing will make it more accessible to patients who may have been deterred by the cost of injections.

What to Know About the Wegovy Pill

The approval of Novo Nordisk’s pill is based on a phase three trial that followed over 300 adults with obesity but not diabetes. The study found that a 25-milligram dose of the oral semaglutide helped patients lose up to 16.6% of their weight on average after 64 weeks. While the pill appears to be slightly more effective than Eli Lilly’s experimental oral drug, it requires dietary restrictions, with patients needing to wait 30 minutes before eating or drinking each day.

Moore downplayed the significance of these restrictions, stating that several existing medicines have similar requirements and that it can actually help patients remember to take their medication. He also highlighted the importance of bringing the cost of the pill closer to that of unapproved, compounded versions of branded GLP-1s, which have been illegally mass-marketed and sold in the US. Novo Nordisk is prepared to meet the demand for the pill, with manufacturing underway at its North Carolina facilities.