The global obesity treatment landscape is changing rapidly. In a landmark decision, the United States Food and Drug Administration (FDA) has approved Wegovy pill, a once-daily oral semaglutide 25mg, as the first oral GLP-1 receptor agonist for long-term weight management. Until now, GLP-1-based therapies that deliver significant weight loss have largely been injectables, limiting acceptance among many patients. The approval is especially noteworthy because it builds on strong clinical evidence showing weight loss comparable to the injectable version of Wegovy, long considered a gold standard in medical obesity treatment. The pill form also carries an approved indication to reduce major adverse cardiovascular events in adults with obesity or overweight and existing heart disease.
Novo Nordisk expects to launch the Wegovy pill in the US in early January 2026. The company had submitted oral semaglutide 25mg once-daily for obesity to the European Medicines Agency (EMA) and other regulatory authorities during the second half of 2025.
For India, where obesity and type-2 diabetes are rising sharply and Ozempic (injectable semaglutide by Novo Nordisk, the company that also launched Wegovy) has only recently entered the market, the development has added significance. It raises questions about how soon oral GLP-1 drugs may reach Indian patients, how they could reshape obesity care, and whether affordability and appropriate use can be ensured in a country with a high burden of metabolic disease.
What The FDA Approval Means For Wegovy Use
According to Novo Nordisk, Wegovy pill is the first oral GLP-1 therapy approved specifically for weight management. The decision is based on the phase-3 OASIS clinical trial programme and supported by earlier STEP and PIONEER trials.
In the OASIS-4 trial, adults with obesity or overweight and at least one comorbidity who adhered to treatment achieved a mean weight loss of 16.6% over 64 weeks, with one in three participants losing 20% or more of their body weight. Importantly, this degree of weight loss is similar to that seen with once-weekly injectable Wegovy. The safety profile was consistent with what is already known about semaglutide, including gastrointestinal side effects such as nausea and vomiting.
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Why Oral GLP-1 Drugs Like Wegovy Matter
GLP-1 receptor agonists work by reducing appetite, slowing gastric emptying and improving glucose control. Large trials published in journals such as The New England Journal of Medicine and The Lancet have shown that semaglutide not only aids weight loss but also lowers cardiovascular risk in high-risk patients. Obesity is now recognised by the World Health Organization (WHO) as a chronic disease requiring long-term management, not just lifestyle advice. An oral option could improve acceptance and adherence, especially among patients hesitant about injections.
"Semaglutide has fundamentally changed how we treat obesity," says Dr. Ambrish Mithal, Group Chairman - Endocrinology & Diabetology, Max Healthcare, New Delhi. "We are seeing weight loss along with a reduction in cardiovascular risks, better kidney health, and improved metabolic markers. But in our country, many patients are hesitant about injectables. If we can offer the same organ protection and efficacy in a pill, we can bridge a massive gap in care. It becomes a daily routine for the patient, which is easily accessible."
Also Read: Does The Craze Around Ozempic Indicate India's Future Drug Dependency Over Holistic Wellness?
What This May Mean For Indians
India faces a dual burden of obesity and diabetes, with the ICMR and WHO warning of rising cardiovascular risk even at lower body mass index (BMI) thresholds in Asian populations. With Ozempic injections now available in India, the approval of Wegovy pill abroad signals what may be next. Novo Nordisk has already submitted the oral formulation to European regulators, suggesting global expansion plans.
"For the Indian healthcare ecosystem, an effective oral anti-obesity drug could be the key to widespread management," Dr. Mithal explains. "It offers the discretion and ease of use that fits seamlessly into the fast-paced lifestyle. We know semaglutide causes weight loss and its safety profile is established. Many patients who might delay starting an injection would likely agree to a pill immediately. This could improve access to high-quality obesity care and allow us to help millions manage their weight more effectively and prevent long-term complications before they start."
However, Indian approval will depend on the Central Drugs Standard Control Organisation (CDSCO), pricing negotiations, and clear clinical guidelines. Experts caution against misuse for cosmetic weight loss and stress the need for prescription-only use under medical supervision.
The FDA approval of Wegovy pill marks a turning point in obesity treatment by bringing powerful GLP-1 therapy into a convenient oral form. For India, where metabolic diseases are surging, this development underscores the need for regulated, evidence-based access to weight-loss medicines. As injectable Ozempic begins to find its place in Indian clinics, the arrival of oral GLP-1 drugs could further transform care, provided safety, affordability and ethical prescribing remain central.
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