FDA Approves Wegovy® Pill - First Oral GLP-1 for Weight Loss
Regulatory approval expands treatment options for obesity and cardiovascular risk reduction
Regulatory Summary
The U.S. Food and Drug Administration approved Wegovy® (semaglutide) oral tablets on December 22, 2025, marking the first oral GLP-1 receptor agonist approved for chronic weight management in adults with obesity or overweight with weight-related medical conditions. The once-daily 25mg tablet formulation provides an alternative to injectable semaglutide for patients seeking weight loss treatment.
Consumer Advisory: This information is for educational purposes only and is not intended as medical advice. Always consult with a qualified healthcare provider before starting any weight loss treatment.
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Section 1: FDA Approval Details
Novo Nordisk's Wegovy® oral tablets received FDA approval on December 22, 2025, representing a significant advancement in obesity pharmacotherapy. This marks the first time a GLP-1 receptor agonist is available in oral formulation for weight management purposes.
Regulatory Approval Summary
Approval Date
December 22, 2025
Market Availability
Early January 2026 (1.5mg starting dose)
Active Ingredient
Semaglutide 25mg per tablet
Dosing Frequency
Once daily oral administration
Approved Indications
- ●Chronic Weight Management: Adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity
- ●Cardiovascular Risk Reduction: Reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight
- ●Adjunctive Therapy: To be used in conjunction with reduced-calorie diet and increased physical activity
Section 2: Clinical Trial Results (OASIS 4 Study)
The FDA approval was supported by data from the OASIS 4 clinical trial, a 64-week randomized, double-blind, placebo-controlled study evaluating efficacy and safety in 307 adults without diabetes.
Primary Efficacy Outcomes
| Outcome Measure | Wegovy® Oral | Placebo |
|---|---|---|
| Weight Loss (Treatment Policy) | ~14% average reduction | ~2% average reduction |
| Weight Loss (On-Treatment) | ~17% average reduction | ~3% average reduction |
| ≥5% Weight Loss Achievement | 76% of patients | Not reported |
Study Duration: 64 weeks | Population: 307 adults without diabetes | Design: Randomized, double-blind, placebo-controlled
Clinical Significance
The 14% average weight loss demonstrated in the treatment policy estimand (which accounts for all randomized patients regardless of treatment adherence) represents clinically meaningful weight reduction. For on-treatment analysis, the 17% average weight loss approaches efficacy levels seen with injectable semaglutide formulations, suggesting comparable therapeutic benefit with improved patient convenience.
Section 3: Safety Profile and Adverse Events
The safety profile of Wegovy® oral tablets is consistent with the GLP-1 receptor agonist class, with gastrointestinal side effects being most commonly reported during clinical trials.
Common Adverse Reactions
Nausea
Most frequently reported gastrointestinal side effect. Typically transient and diminishes with continued treatment.
Diarrhea
Common during initial titration phase. Healthcare providers may adjust dosing schedule to mitigate symptoms.
Vomiting
Reported in subset of patients, particularly during dose escalation periods.
Serious Adverse Events and Contraindications
- !Pancreatitis: Risk of acute pancreatitis. Discontinue if suspected and do not restart unless alternative etiology confirmed.
- !Gallbladder Disease: Increased risk of cholelithiasis and cholecystitis requiring clinical monitoring.
- !Thyroid Tumors: Contraindicated in patients with personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
- !Acute Kidney Injury: Dehydration-related renal impairment possible, particularly with gastrointestinal adverse reactions.
Section 4: Market Availability and Pricing
Novo Nordisk announced immediate manufacturing readiness with robust supply available at their North Carolina production facilities.
Launch Timeline
- ●FDA Approval: December 22, 2025
- ●Initial Availability: Early January 2026 (1.5mg starting dose)
- ●Manufacturing: North Carolina facilities with robust supply on hand
Pricing Information
Starting Price: $149 per month (1.5mg dose with savings offers)
Note: Pricing may vary by insurance coverage, pharmacy, and available manufacturer savings programs. Patients should consult with their healthcare provider and insurance company for specific cost information.
Access Considerations
The oral formulation of Wegovy® may improve treatment accessibility for patients who prefer oral medications over injectable formulations. Healthcare providers can prescribe either formulation based on individual patient preferences, medical history, and clinical considerations. Verified telehealth providers featured on this site may offer both injectable and oral semaglutide options where clinically appropriate.