The U.S. Food and Drug Administration (FDA) approved Novo Nordisk's oral semaglutide for chronic weight management in adults on December 22. The medication, marketed as an oral form of Wegovy, began its U.S. rollout in early January, becoming the first FDA-approved oral treatment for obesity. This introduction aims to provide a convenient alternative to injectable weight-loss medications, with varying price points and broad distribution channels.
Regulatory Approval and Indication
The FDA approved the oral formulation of Wegovy for chronic weight management in adults with obesity or those who are overweight with at least one weight-related comorbidity. Additionally, the approval label includes an indication for reducing the risk of major cardiovascular events, such as heart attack, stroke, or cardiovascular death, in adults with obesity and established cardiovascular disease. This expanded indication aligns with that of the injectable Wegovy.
Medication Details
Novo Nordisk's oral semaglutide pill contains the same active ingredient as its injectable counterparts, Wegovy and Ozempic, and the Type 2 diabetes pill Rybelsus, but in a higher 25-milligram dose for weight management. It functions as a GLP-1 agonist, mimicking a natural gut hormone to regulate appetite and promote feelings of satiety.
Efficacy:
Clinical trials have demonstrated the medication's effectiveness:
- In a study published in the New England Journal of Medicine, participants administered the 25 mg oral semaglutide dose experienced an average weight reduction of 13.6% over approximately 15 months (64 weeks), compared to a 2.2% loss in the placebo group.
- For patients adhering to the treatment regimen, reducing caloric intake, and engaging in exercise, an average weight reduction of 16.6% over 64 weeks was observed.
- The reported weight loss is comparable to that of the injectable version of Wegovy, which demonstrated an average weight loss of about 15%.
Administration and Side Effects:
The oral medication requires once-daily administration. For optimal absorption, it must be taken on an empty stomach with a small amount of water, followed by a 30-minute waiting period before consuming food or other beverages. This protocol is due to the inclusion of sodium N-(8-[2-hydroxybenzoyl]amino)caprylate (SNAC), an absorption enhancer that protects the medication from stomach acids and increases cellular permeability. Common side effects reported are consistent with those of injectable GLP-1 agonists, including nausea and diarrhea.
Availability and Pricing
The initial dose of the oral Wegovy became available in U.S. pharmacies in early January, with higher doses scheduled for release shortly thereafter.
Pricing Structure:
- The starting dose (1.5 milligrams) is available for $149 per month for cash-paying patients.
- The 4-milligram dose is priced at $149 per month until April 15, after which it will be $199 per month.
- The highest doses (9 milligrams and 25 milligrams) are available for $299 per month for cash-paying patients.
- For insured patients, monthly out-of-pocket costs may be as low as $25, depending on their insurance coverage.
- The list price, which influences insurance coverage, is approximately $1,349 per month, comparable to the injectable Wegovy.
Distribution Channels:
The oral medication is available at over 70,000 U.S. pharmacies, including major chains like CVS and Costco. It is also distributed through telehealth providers such as Ro, LifeMD, Weight Watchers, GoodRx, and Novo Nordisk's NovoCare Pharmacy. Amazon Pharmacy began offering the medication starting January 12. Additionally, an agreement with the Trump administration allows for the starting dose to be sold directly to consumers for $149 per month via the TrumpRx platform upon its launch.
Market Landscape and Competition
The introduction of oral semaglutide marks a significant development in the obesity treatment market, which has historically been dominated by higher-priced weekly injectable medications. Analysts project the global weight loss drug market could reach approximately $100 billion by the 2030s, with oral drugs potentially comprising about 24% of this market by 2030.
Eli Lilly's Orforglipron:
Novo Nordisk's launch precedes a decision by the FDA regarding a competing oral obesity pill from Eli Lilly, called orforglipron. Eli Lilly, manufacturer of injectable Zepbound and Mounjaro, submitted orforglipron for FDA approval in late 2023, with a priority review voucher potentially expediting the decision process to within months, expected by spring.
- Orforglipron features a novel ingredient distinct from Eli Lilly's injectable tirzepatide.
- Unlike oral semaglutide, orforglipron is designed with greater stability in the stomach and does not require specific food or water restrictions for effective absorption.
- In clinical trials, orforglipron, at its highest dose, resulted in an average weight loss of 11.2% over nearly 17 months (72 weeks), compared to 2.1% in the placebo group. This efficacy is noted to be lower than existing injectable treatments and oral semaglutide.
Initial Prescription Data
Early prescription data for Novo Nordisk's oral semaglutide in the U.S. indicated approximately 3,100 prescriptions were filled in its first week, according to IQVIA data for the week ending January 9. Symphony data cited approximately 4,290 prescriptions during its first full week. These figures are predominantly for the starting dose and may exclude prescriptions processed through direct-to-consumer pharmacy or telehealth partners. For comparison, Eli Lilly's injectable Zepbound had about 1,300 prescriptions in its first week and roughly 8,000 in its second week after its late 2023 U.S. approval.
Future Outlook
Both Novo Nordisk and Eli Lilly are continuing to advance new compounds in late-stage clinical trials, including Novo Nordisk's cagrilintide and a combination of cagrilintide and semaglutide, and Eli Lilly's retatrutide. Other companies, such as Metsera, are also developing obesity drugs. The availability of oral medication options is anticipated to increase access to obesity treatment, potentially reaching individuals who prefer pills over injections. The UK's medicines regulator is also evaluating Novo Nordisk's application for its oral Wegovy formulation.