---
type: entity
entity_type: protocol
name: Wegovy Oral (Oral Semaglutide)
parent_company: Novo Nordisk
status: FDA approved
domain: health
---

# Wegovy Oral (Oral Semaglutide)

**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 risk reduction in adults with CVD + obesity/overweight

## Overview

First oral GLP-1 receptor agonist approved for weight management. Eliminates injection barrier that limited injectable semaglutide (Wegovy) adoption.

## Clinical Evidence

**OASIS 4 Trial (Phase III):**
- Duration: 64 weeks
- Population: n=307
- Primary endpoint: Weight loss 16.6% (treatment) vs 2.7% (placebo) with reduced calorie diet + exercise
- Safety: Serious adverse events 3.9% (treatment) vs 8.8% (placebo)
- Common adverse reactions: nausea, vomiting, diarrhea (standard GLP-1 class profile)

## Regulatory Status

**FDA Label (January 2026):**
- Boxed warning: Thyroid C-cell tumor risk (standard GLP-1 class warning)
- NO eating disorder warning or screening requirement
- Suicidal behavior/ideation warning REMOVED in 2026 review (no causal link found)
- No contraindications for psychiatric comorbidity or eating disorder history

## Market Significance

Oral formulation expands addressable GLP-1 population by eliminating injection barrier. Accelerates trajectory toward mass-market adoption (1-in-8 Americans forecast).

## Manufacturing

Novo Nordisk North Carolina facilities.

## Timeline

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