US FDA Approves First Daily Oral GLP‑1 Treatment for Weight Management, Showing Comparable Results to Injectable Therapy

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The US Food and Drug Administration (FDA) has approved Novo Nordisk's new once-daily pill for weight management, designed to help people reduce excess body weight and maintain weight reduction over the long term. In clinical trials, patients achieved an average weight reduction of 16.6% from baseline. The therapy is also indicated to lower the risk of major cardiovascular events* such as heart attack and stroke in certain patients. Novo Nordisk expects to launch the pill in the United States in early January 2026.

JAKARTA, Indonesia, Jan. 28, 2026 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved a once-daily oral GLP‑1 medicine to help people reduce excess body weight and maintain weight loss over the long term. The Novo Nordisk treatment marks a milestone in medical obesity care by offering the convenience of a pill with weight-loss results comparable to therapies that have typically required injections. The approval provides a new option for patients who need medical support for obesity but have been reluctant to use needles.

Data from the global OASIS 4 clinical trial showed the once-daily pill delivered significant weight-loss results. Participants lost an average of 16.6% of their starting body weight after about a year of consistent treatment.^[1] One in three patients achieved weight loss of more than 20%—a level that can translate into meaningful improvements in daily functioning and quality of life for people living with obesity. The findings suggest the oral option can deliver weight loss comparable to the once-weekly injectable version already available.

Beyond weight loss, the therapy is also approved to reduce the risk of serious heart and cardiovascular problems, including heart attack and stroke, in certain patient groups. Clinical data showed approximately a 20% reduction in cardiovascular risk among patients with heart disease who also have obesity or overweight. This means obesity management with this therapy addresses more than appearance—it offers meaningful protection for heart health and the potential to extend lifespan.

"The pill is here. With the approval of our once-daily oral GLP-1 treatment, patients will have a convenient pill option that can help them achieve weight loss comparable to injectable therapy," said Mike Doustdar, president and CEO of Novo Nordisk. "As the first oral GLP-1 treatment for people living with overweight or obesity, this new option provides patients with a convenient choice to start or continue their weight loss journey. No other current oral GLP-1 treatment can match the weight loss results delivered by this therapy, and we are very excited for what this will mean for patients."

The development has drawn attention as Indonesia faces a growing obesity challenge. According to the 2023 Indonesia Health Survey (Survey Kesehatan Indonesia, SKI), the obesity rate among adults has reached 23.4%—meaning roughly one in four adults lives with obesity. Central obesity, often reflected in abdominal fat, was recorded at 36.8% among people aged 15 and above. These conditions increase the risk of chronic diseases including type 2 diabetes, hypertension, heart disease and stroke. Beyond the health impact, obesity also carries an economic cost: a 2016 study by Bogor Agricultural University (IPB) estimated obesity-related losses in Indonesia at around tens of billions of rupiah annually when factoring in healthcare spending and productivity losses.

From Indonesia's perspective, Sreerekha Sreenivasan, General Manager of Novo Nordisk Indonesia, emphasized that this breakthrough is a vital part of a long-term mission to transform obesity care. "In Indonesia, we are facing a critical rise in obesity, which frequently acts as a gateway to other life-threatening conditions like diabetes and heart disease. For many, lifestyle changes alone are not enough, and they deserve access to comprehensive medical support," she stated. "The rapid pace of scientific innovation, including the innovation of GLP-1 therapies, proves that the medical community is now better equipped than ever to treat obesity as the serious chronic disease it is—moving the conversation far beyond personal appearance and toward long-term health and survival," she added.

Sreenivasan emphasized that Novo Nordisk's current focus in Indonesia is collaborating with healthcare professionals and other stakeholders to strengthen the understanding that obesity is a serious chronic disease requiring medical attention. "We are currently very focused on education, building healthcare capacity, and expanding access to existing treatments. At present, a once-weekly injectable GLP-1 therapy from Novo Nordisk is already available in Indonesia as a medical solution for patients," she explained.

Experts emphasize that obesity is a complex, chronic disease—not simply the result of a lack of willpower or discipline. In people with obesity, hormonal systems that regulate hunger and fullness are often disrupted, causing the body to resist weight loss and defend a higher weight. GLP‑1–based treatments work by mimicking a natural hormone that acts on appetite centers in the brain, helping people feel fuller for longer, reduce food intake, and achieve gradual, more sustainable weight loss.

Although the GLP-1 pill is expected to reach the US market in early January 2026, the development signals where obesity treatment is heading globally. The public is encouraged to view obesity as a medical condition that deserves serious care— not simply a matter of personal appearance. People who struggle to lose weight, have abdominal obesity, or have been diagnosed with related conditions such as diabetes or hypertension are advised to consult a doctor for a comprehensive assessment and an appropriate treatment plan.

More information on obesity, its health risks, and evidence-based approaches to weight management is available on the educational website platform NovoCare.id. The site provides easy-to-understand resources for the public, including information on the role of modern treatments such as GLP‑1 therapies in supporting long-term obesity management.

Novo Nordisk's GLP‑1 treatment for weight management is a prescription medicine prescribed by healthcare professionals following consultation. It is used alongside a reduced-calorie diet and increased physical activity to help adults with obesity or overweight manage their weight. Obesity is often accompanied by other conditions such as type 2 diabetes, high blood pressure, elevated blood lipids, heart disease, and joint pain. Clinical studies have demonstrated that GLP‑1–based weight management therapy can help many patients achieve significant weight loss and improve various risk factors associated with heart health and metabolic function.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.id, Facebook, Instagram, X, LinkedIn, and YouTube. 

SOURCE Novo Nordisk