FDA Approves Wegovy Pill: A New Era for Weight Loss Medication

The U.S. Food and Drug Administration (FDA) has greenlit Wegovy in pill form, marking the first oral version of the semaglutide-based weight loss drug produced by Novo Nordisk. This approval sets the stage for a more convenient and accessible therapeutic option for obesity, strengthening Novo Nordisk's competitive edge against Eli Lilly, which awaits approval for its own anti-obesity pill, orforglipron.

Market Response and Stock Performance

The FDA's announcement immediately impacted the market. Novo Nordisk's shares surged by over 7% on the Copenhagen Stock Exchange, following an 8.98% increase in after-hours trading on Wall Street. In contrast, Eli Lilly experienced a slight dip in premarket trading, down by 1.15%.

The Science Behind Wegovy Pill

Wegovy's active ingredient, semaglutide, is the same as in the injectable version of Wegovy and Ozempic, a diabetes medication. These drugs mimic the GLP-1 intestinal hormone, reducing appetite and promoting weight loss. Until now, all GLP-1 drugs, including Eli Lilly's Zepbound and Mounjaro, were administered via weekly injections. According to research group Kff, approximately one in eight adults in the U.S. currently use these drugs, indicating a significant market potential for oral versions.

Clinical Trial Results

Clinical data supports the efficacy of Wegovy pill. In Phase 3 trials lasting 64 weeks, the 25 mg oral version resulted in an average weight loss of 16.6%, compared to 2.7% in the placebo group. A third of participants experienced a reduction of over 20%. Other studies, including those who discontinued treatment, showed an average loss of 13.6%, confirming the robustness of the results. Common side effects include gastrointestinal issues like nausea and vomiting, with 7% of participants discontinuing treatment due to these effects, versus 6% in the placebo group.

Dosage and Precautions

Taking Wegovy pill requires specific precautions: it must be ingested on an empty stomach about 30 minutes before meals or other medications, with a small amount of water. While this ensures efficacy, it is less convenient than Eli Lilly's orforglipron, which can be taken without dietary or water restrictions.

Pricing and Availability

The initial dose of 1.5 mg will be available in the U.S. starting in January 2026 at $149 per month, applicable to patients covered by government programs like Medicare and Medicaid, as well as customers of the TrumpRx direct service, according to the agreement between Novo Nordisk, Eli Lilly, and the U.S. government. Long-term administration doses will be 1.5 mg, 4 mg, 9 mg, and 25 mg.

Dr. Judith Korner, an endocrinologist at Columbia University, explains that the lowest dose mainly helps the body adjust to the medication and rarely corresponds to the final dose needed to achieve the desired results.

Competitive Landscape

The Wegovy pill enters a rapidly evolving competitive landscape. Eli Lilly's orforglipron is expected by the end of March 2026 and showed an average weight loss of 11% at the highest dose over 72 weeks in clinical trials, compared to 2% for the placebo. Zepbound, at the maximum dose, showed a 21% reduction in body weight, versus 3% for the placebo. Lilly studies also indicate that patients switching to orforglipron after losing weight with injectable drugs tend to regain less weight, suggesting a strategic role for pills in weight maintenance.

The arrival of oral GLP-1 drugs presents significant clinical opportunities.

According to Dr. Korner, the main considerations for a new drug are efficacy, safety, and cost.

While maintaining the same effects as the injectable version, Wegovy pill offers an opportunity to improve cardiovascular health, reduce sleep apnea, improve liver function, and limit the risks associated with obesity.

Dave Moore, executive vice president of U.S. operations at Novo Nordisk, emphasizes that the expansion into pill form will help patients who previously would not have sought treatment, while Anand Iyer, chief AI Officer of Welldoc, anticipates a growth in the patient base with the arrival of oral versions.

Novo Nordisk's Strategic Move

The approval of Wegovy pill triggered an immediate rally in Novo Nordisk's shares. However, the year-to-date balance remains negative, with a decrease of almost 50%, due to slowing sales and profit warnings. With the oral version of the weight loss drug, the company aims to regain ground, reach millions of new patients in a market estimated at up to $150 billion over the next ten years, and solidify its position against competitors like Eli Lilly.

Efficacy of Wegovy Pill

In Phase 3 clinical trials, Wegovy pill demonstrated significant weight loss compared to the placebo group. The average weight loss was 16.6% with the 25 mg oral version, while the placebo group only experienced a 2.7% reduction.

The following table summarizes the key findings from the clinical trials:

Side Effects and Discontinuation Rates

The most common side effects reported were gastrointestinal issues, such as nausea and vomiting.

The following table shows the discontinuation rates due to these side effects:

Pricing and Dosage Details

Wegovy pill will be available in multiple dosages to accommodate individual patient needs.

Here is a table detailing the dosages and initial pricing:

Competitive Drug Comparison

Several weight loss drugs are in development or already on the market, including Eli Lilly's orforglipron and Zepbound.

The following table compares the weight loss efficacy of these drugs:

Market Impact on Novo Nordisk and Eli Lilly

The FDA approval of Wegovy pill has significantly boosted Novo Nordisk's stock, while Eli Lilly has seen a more muted response.

Here is a table summarizing the immediate stock market impact:

Future Opportunities with Oral GLP-1 Drugs

The introduction of oral GLP-1 drugs like Wegovy pill offers numerous clinical advantages and opportunities. These include improved cardiovascular health, reduced sleep apnea, better liver function, and decreased risks associated with obesity.

Patient Accessibility and Market Expansion

With the availability of Wegovy in pill form, more patients who were previously hesitant to seek treatment may now consider it. This expansion into oral medications is expected to broaden the patient base and drive significant growth in the weight loss market.