Wegovy Pill From Novo Nordisk

The FDA recently approved once-daily oral semaglutide 25 mg (Wegovy pill; Novo Nordisk, Inc) to reduce excess body weight, maintain long-term weight reduction, and reduce the risk of major adverse cardiovascular events among individuals with overweight or obesity.¹

Individuals with a body mass index (BMI) of 25 or greater are classified as overweight, and those with a BMI of 30 or greater are classified as obese. BMI is calculated using an adult’s height and weight.²

Globally, adult obesity has more than doubled since 1990. As of 2022, 1 in 8 individuals worldwide were living with obesity, representing approximately 890 million among the 2.5 billion adults 18 years and older classified as overweight. According to the World Health Organization, overweight and obesity are a result of an imbalance of diet and physical activity, which can be caused by environmental and psychosocial factors and genetic variants.²

Patients who experience overweight or obesity can work closely with health care providers who can provide counseling on nutrition, physical activity, and, when appropriate, glucagon-like peptide-1 (GLP-1) receptor agonist medications, such as injectables or oral options.²

Pharmacology and Pharmacokinetics

The Wegovy pill is the first oral GLP-1 receptor agonist approved for weight management, offering a noninjectable alternative with weight-loss efficacy comparable to that of the original injectable formulation.¹

Currently, semaglutide is approved by the FDA for weight management and is available as a once-daily oral 25-mg tablet and a once-weekly 2.4-mg injectable formulation. The medication aims to reduce excess body weight and maintain weight reduction long-term in adults with obesity or overweight who experience at least 1 weight-related comorbid condition. Semaglutide was also approved by the FDA to reduce the risk of major cardiovascular events, including stroke, in adults with known heart disease and either obesity or overweight.¹

Clinical Trials

The FDA approval for the Wegovy pill is based on data from the 64-week, phase 3b OASIS 4 trial (NCT05564117), which assessed the efficacy and safety of once-daily oral semaglutide 25 mg compared with placebo in 307 adults with obesity or overweight with 1 or more comorbidities. Results demonstrated that oral semaglutide 25 mg, taken once daily, achieved a mean weight loss of 16.6% when patients adhered to treatment. The trial showed that weight loss with the pill was comparable to that achieved with the 2.4-mg injectable form. Further results from OASIS 4 found that 1 in 3 patients lost 20% or more of their body weight.^1,3

Contraindications, Warnings, and Precautions

The Wegovy pill has a safety profile consistent with that of other GLP-1 receptor agonists, with gastrointestinal adverse effects, such as nausea, vomiting, diarrhea, and constipation, being most common, especially during dose escalation. These effects are typically temporary and manageable, while standard warnings, including risks of pancreatitis, gallbladder disease, and thyroid C-cell tumors, remain applicable and are noted in prescribing information.⁴

References

1. Novo Nordisk A/S: Wegovy pill approved in the US as first oral GLP-1 for weight management. News release. Novo Nordisk. December 22, 2025. Accessed January 5, 2026. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916472

2. Obesity and overweight. World Health Organization. Updated December 8, 2025. Accessed January 5, 2026. https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight

3. Semaglutide effects on heart disease and stroke in patients with overweight or obesity (SELECT). ClinicalTrials.gov. Updated August 30, 2024. Accessed January 5, 2026. https://clinicaltrials.gov/study/NCT03574597

4. Valletti D. FDA approves first oral GLP-1 for weight management. Pharmacy Times. December 23, 2025. Updated January 2, 2026. Accessed January 5, 2026. https://www.pharmacytimes.com/view/fda-approves-first-oral-glp-1-for-weight-management