REG-FDA-Wegovy-Label — Current FDA Prescribing Information (NDA 215256)

[DRAFT — authored 2026-04-20. NDA 215256 current label URL verified 2026-04-20.]

Source

US Food and Drug Administration. Wegovy (semaglutide) injection, for subcutaneous use — Prescribing Information. NDA 215256, Novo Nordisk.

External URLs:

Current Label Indications (as of April 2026)

Wegovy is indicated for:

1. Chronic weight management

Adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) in the presence of at least one weight-related comorbidity (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, cardiovascular disease) as an adjunct to a reduced-calorie diet and increased physical activity.

2. Pediatric chronic weight management (≥12 years)

Adolescents aged 12 years and older with an initial BMI at the 95th percentile or greater. Supported by STEP TEENS trial (Weghuber D et al., NEJM 2022;387(24):2245-2257, PMID 36322838).

3. Cardiovascular risk reduction — added March 8, 2024

To reduce the risk of major adverse cardiovascular events (MACE) — specifically cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke — in adults with established cardiovascular disease + obesity (BMI ≥30) or overweight (BMI ≥27). Based on the SELECT trial (Lincoff AM et al., NEJM 2023, PMID 37952131): 20% relative reduction in MACE. Cross-reference regulatory note: REG-FDA-Wegovy-MACE-2024 – Cardiovascular Risk Reduction Approval.

4. Higher-dose (7.2 mg) — added March 19, 2026

Adults with obesity (BMI ≥30) who have tolerated 2.4 mg weekly for at least 4 weeks and require additional weight reduction. Approved via the Commissioner's National Priority Voucher Program (fourth NPV-approved product; 54-day review). Based on STEP UP (Wharton S et al., Lancet Diabetes Endocrinol 2025, PMID 40961952). Cross-reference regulatory note: REG-FDA-Wegovy-HD-2026 – Wegovy 7.2 mg National Priority Voucher Approval.

5. Oral formulation (Wegovy oral / Rybelsus 25 mg) — added August 2025

Oral semaglutide 25 mg for chronic weight management in adults, based on OASIS 4 trial (PMID 40934115). (Note: Rybelsus 14 mg remains T2D-indication only; the 25 mg dose is approved for obesity under the Wegovy brand.)

Dosing Summary (Current Label)

Product	Dose	Route	Indication
Wegovy 2.4 mg	Weekly, titrated over 17 wk	SC	Obesity, MACE reduction, adolescent obesity
Wegovy 7.2 mg	Weekly (after ≥4 wk at 2.4 mg)	SC	Obesity — additional weight reduction
Wegovy oral 25 mg	Daily	Oral	Obesity
Rybelsus 7/14 mg	Daily	Oral	T2D
Ozempic 0.25/0.5/1.0/2.0 mg	Weekly	SC	T2D

Boxed Warning

Risk of thyroid C-cell tumors. Contraindicated in patients with:

Personal or family history of medullary thyroid carcinoma (MTC)
Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Based on rodent C-cell tumor findings (mechanism note: PMID 20203154).

Key Contraindications (current label)

Personal/family history of MTC or MEN 2
Known hypersensitivity to semaglutide or excipients

Key Warnings and Precautions

Pancreatitis (discontinue if suspected)
Acute gallbladder disease
Hypoglycemia when combined with insulin or sulfonylureas
Acute kidney injury (from severe dehydration secondary to GI symptoms)
Hypersensitivity reactions
Retinopathy complications in T2D (monitor)
Heart rate increase
Suicidal behavior and ideation — warning removed per FDA 2025 action (cross-reference REG-FDA-Suicidal-Ideation-Review-2024 – FDA GLP1 Suicidal Ideation Null Finding)

Pregnancy / Nursing

Not recommended during pregnancy. Discontinue ≥2 months before planned conception. Cross-reference PMID-40329607 – Parker GLP-1 Pregnancy Regulatory Safety Data for pooled regulatory pregnancy data.

Regulatory Divergence with EMA (April 2026)

NAION labeling: EMA requires NAION warning in SmPC ("very rare" classification, June 2025 PRAC). FDA label has not been updated for NAION as of April 2026. Cross-reference REG-EMA-PRAC-Semaglutide-NAION-2025 – EMA NAION Very Rare.
MASH indication: FDA approved MASH indication August 15, 2025. EMA MASH indication status requires verification.

Clinical Relevance

This is the single authoritative source for current US prescribing of Wegovy. Clinicians must consult the current label for any dosing or indication question. The label has evolved substantially since the 2021 initial approval:

June 2021: Initial approval for adult obesity
December 2022: Adolescent obesity (≥12 years) indication added
March 8, 2024: MACE-reduction indication added (SELECT basis)
August 2025: MASH indication added (ESSENCE basis); oral Wegovy 25 mg approved
March 19, 2026: Wegovy 7.2 mg higher-dose approved (NPV pathway; STEP UP basis)

Linked Peptides

Semaglutide

REG-FDA-Wegovy-Label-2025-2026 – Current FDA Prescribing Information