Novo Nordisk is one step closer to receiving approval for its oral version of its weight-loss medication, Wegovy. On May 2, 2025, the Wall Street Journal reported that the U.S. Food and Drug Administration (FDA) had accepted Novo Nordisk’s application.
Should the FDA approve oral Wegovy, then it could mark a significant moment in the history of obesity treatment.
Background: What is Wegovy?
Currently, Wegovy is available only as an injectable medication. Specifically, it contains semaglutide, a GLP-1 receptor agonist that helps reduce appetite and regulate blood sugar. Overall, many patients use it to manage obesity or overweight conditions linked to type 2 diabetes and heart disease.
So far, injections have dominated the market. However, pills may offer a more convenient option for many. For instance, many patients often prefer oral medications due to ease of use and comfort. As a result, Novo Nordisk’s application signals a possible shift in treatment delivery.
FDA Application and Scope
The FDA is now reviewing Novo Nordisk’s New Drug Application (NDA) for 25 mg oral semaglutide, or Wegovy. This version targets adults with obesity or overweight who also have at least one health-related condition. These include hypertension, type 2 diabetes, or high cholesterol.
Notably, the industry expects the FDA to make a decision in the fourth quarter of 2025. That timeline reflects the typical pace for reviewing new obesity treatments. Meanwhile, investors and healthcare providers are closely watching for updates.
Oral Wegovy Results
Novo Nordisk submitted data from its Phase 3 OASIS 4 trial, which lasted 64 weeks and included 307 adult participants. Results showed that patients taking oral semaglutide (aka Wegovy) experienced significant weight loss compared to those receiving a placebo.
Moreover, the pill’s safety profile closely matches that of the injectable form. As such, this reinforces its potential as a safe alternative. Therefore, approval seems increasingly likely if no surprises arise.
Market Competition and Demand
Generally, the global obesity treatment market is booming. In time, it could reach $150 billion in value within a few years. Correspondingly, with this application, Novo Nordisk aims to lead in both injectable and oral weight-loss therapies (including Wegovy).
However, competition is heating up. Eli Lilly is developing orforglipron, its own oral GLP-1 receptor agonist. Thus, Novo Nordisk faces strong pressure to stay ahead.
Despite that, investor confidence remains high. Shares in Novo Nordisk rose following news of the FDA’s acceptance. Clearly, the market sees major potential in a Wegovy pill.
Reactions to Oral Wegovy
Anna Windle, Director of Clinical Development, Medical & Regulatory Affairs, emphasized the importance of expanding access.
“We are entering a new era in obesity treatment, where patients want individualized treatment plans that meet their needs and offer choices, including oral formulations,” she remarked, about the oral version of Wegovy.
Many people, including doctors, believe that an effective pill could lead to higher long-term patient engagement. Additionally, easier access may help reduce obesity-related complications across different populations.
New Era for Obesity Treatment
If it receives approval, oral Wegovy will mark a new chapter in weight-loss care. It could make treatment more accessible and patient-friendly.
As the FDA review continues, the healthcare community watches with anticipation. Approval would not only benefit patients but also reshape the weight-loss drug market entirely.
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