# Oral Wegovy (Semaglutide Pill)

**Type:** GLP-1 receptor agonist, oral formulation  
**Manufacturer:** Novo Nordisk  
**Status:** FDA approved January 2026  
**Indication:** Weight management in adults with obesity or overweight + ≥1 comorbidity; cardiovascular event risk reduction in adults with CVD + obesity/overweight

## Clinical Profile

**OASIS 4 Trial (Phase III, 64 weeks, n=307):**
- Weight loss: 16.6% with oral Wegovy + lifestyle intervention vs. 2.7% placebo
- Serious adverse events: 3.9% treatment vs. 8.8% placebo (lower in treatment arm)
- Common adverse reactions: nausea, vomiting, diarrhea
- Efficacy comparable to injectable formulation for this population

## Safety Label

- **Boxed warning:** Thyroid C-cell tumor risk (standard GLP-1 class warning)
- **NO eating disorder warning** in label
- **Suicidal behavior/ideation warning REMOVED** in 2026 FDA review (no causal link found)
- No eating disorder screening requirement in prescribing information

## Market Significance

- First oral GLP-1 formulation for weight management
- Eliminates injection barrier, expanding addressable patient population
- Manufacturing at North Carolina facilities
- Launched January 2026

## Timeline

- **2026-01-01** — FDA approval for weight management and cardiovascular risk reduction
- **2026-01-01** — Commercial launch with North Carolina manufacturing