Wegovy
Wegovy is Novo Nordisk’s semaglutide product for obesity-related and adjacent cardiometabolic indications. In the United States, the name now covers subcutaneous injection and oral tablet products with different population and indication boundaries. Wegovy is not another name for semaglutide generally, and its label should not be transferred to Ozempic, Rybelsus, or other GLP-1 products.
The US record reviewed here is current to July 23, 2026. The current DailyMed prescribing information should be checked before reusing indication, population, formulation, dose, safety, or availability claims.
Reference record
Section titled “Reference record”| Field | Wegovy record |
|---|---|
| Entity type | Prescription drug product and brand |
| Active ingredient | Semaglutide |
| Drug class | GLP-1 receptor agonist |
| Principal company | Novo Nordisk |
| US routes | Subcutaneous injection and oral tablet |
| US applications | NDA 215256 for injection; NDA 218316 for tablets |
| Initial US approval | June 4, 2021 |
| Major clinical programs | STEP, SELECT, ESSENCE, and OASIS |
Product identity
Section titled “Product identity”Wegovy is a product-level record. Semaglutide is its active ingredient, while the injection, tablet, strengths, delivery presentations, populations, and indications belong to the product label.
This distinction matters because semaglutide also appears in Ozempic and Rybelsus. Those diabetes-market products share an ingredient and company portfolio but remain separate regulatory and commercial records. Shared ingredient identity does not make their labels, doses, routes, or market roles interchangeable.
Current US label scope
Section titled “Current US label scope”The current label separates Wegovy injection from Wegovy tablets.
| Label area | Wegovy injection | Wegovy tablets |
|---|---|---|
| Long-term weight reduction | Adults with obesity; adults with overweight and at least one weight-related comorbid condition; pediatric patients aged 12 years and older with obesity | Adults with obesity; adults with overweight and at least one weight-related comorbid condition |
| Cardiovascular-risk reduction | Adults with established cardiovascular disease and either obesity or overweight | Adults with established cardiovascular disease and either obesity or overweight |
| Noncirrhotic MASH with moderate to advanced fibrosis | Adults; accelerated approval with confirmatory-evidence requirements | Not included in the current tablet indication |
| Pediatric use | Weight-reduction indication includes patients aged 12 years and older with obesity | Safety and effectiveness have not been established in pediatric patients |
| Route | Subcutaneous injection | Oral tablet |
The MASH indication applies to noncirrhotic metabolic dysfunction-associated steatohepatitis with fibrosis consistent with stages F2 to F3. FDA granted accelerated approval for this indication, meaning continued approval may depend on verification and description of clinical benefit in a confirmatory trial.
Formulations and presentations
Section titled “Formulations and presentations”Wegovy’s formulation history is part of its industry identity.
| Product presentation | Regulatory and market context |
|---|---|
| Once-weekly injection | The original Wegovy product approved in 2021. Current US presentations include single-dose pens and syringes as well as a multi-dose FlexTouch presentation described in the label. |
| Wegovy HD injection | A 7.2 mg presentation approved on March 19, 2026, for weight reduction and long-term maintenance in certain adults. The higher dose is not a blanket extension to every Wegovy indication or population. |
| Once-daily tablets | Approved under separate NDA 218316 in December 2025 for adult weight reduction and cardiovascular-risk reduction. The tablet label does not include the injection’s pediatric or MASH scope. |
These differences are regulatory and product attributes, not merely alternative delivery preferences. Route, presentation, strength, population, and indication should remain separate structured fields.
Company and application roles
Section titled “Company and application roles”Novo Nordisk developed and commercializes Wegovy. FDA’s original injection approval package and later tablet approval letter identify Novo Nordisk Inc. as the US application recipient.
| Record | Role captured |
|---|---|
| NDA 215256 | Original and supplemental US regulatory record for Wegovy injection |
| NDA 218316 | Separate US application for Wegovy tablets |
| Current DailyMed label | Product-specific labeling, presentation, packager, and marketing information |
These records support sponsor and application-holder context. They should not be used by themselves to infer the physical manufacturer of every presentation, the source of every component, regional distribution arrangements, or uninterrupted supply.
Clinical-development map
Section titled “Clinical-development map”| Program or study | Wegovy relationship | Interpretation boundary |
|---|---|---|
| STEP 1, NCT03548935 | Adult once-weekly subcutaneous semaglutide weight-management study within the STEP program | One trial does not define every Wegovy population, formulation, or indication. |
| STEP TEENS, NCT04102189 | Supported the adolescent obesity development record associated with the December 2022 pediatric label expansion | Pediatric evidence and labeling should not be generalized to younger children or to Wegovy tablets. |
| SELECT, NCT03574597 | Cardiovascular outcomes study in people with overweight or obesity and prior cardiovascular disease | The cardiovascular indication is tied to a defined population and endpoint. |
| ESSENCE, NCT04822181 | Phase 3 MASH program connected to the accelerated-approval indication for Wegovy injection | The trial continues to evaluate longer-term clinical benefit; accelerated approval is not the same as completed confirmatory evidence. |
| OASIS 4, NCT05564117 | Oral semaglutide 25 mg study in adults with overweight or obesity, connected to the tablet development program | Oral and injectable results should remain formulation- and study-specific. |
Specific outcome comparisons belong in dated clinical-program records that preserve population, comparator, duration, endpoint definition, and analysis context.
US regulatory history
Section titled “US regulatory history”| Date | Event | Product significance |
|---|---|---|
| June 4, 2021 | FDA approved Wegovy injection under NDA 215256 for chronic weight management in defined adult populations. | Established Wegovy as the obesity-market semaglutide product in the United States. |
| December 23, 2022 | FDA approved an injection indication for chronic weight management in pediatric patients aged 12 years and older with obesity. | Expanded the product record beyond adults while retaining population-specific limits. |
| March 8, 2024 | FDA added a cardiovascular-risk-reduction indication for adults with established cardiovascular disease and obesity or overweight. | Connected Wegovy to the SELECT outcomes program and a non-weight endpoint. |
| August 15, 2025 | FDA granted accelerated approval to Wegovy injection for noncirrhotic MASH with moderate to advanced fibrosis in adults. | Added a liver-disease indication with an ongoing confirmatory requirement. |
| December 2025 | FDA approved Wegovy tablets under NDA 218316 for adult weight reduction and cardiovascular-risk reduction. | Added an oral Wegovy product with its own population and indication scope. |
| January-February 2026 | FDA requested removal of suicidal behavior and ideation language from affected GLP-1 weight-management labels after its review did not identify an increased risk; the current Wegovy label records the removal. | Illustrates that safety-label records change and should be tied to the current label and dated FDA communication. |
| March 19, 2026 | FDA approved the 7.2 mg Wegovy HD injection dose for weight reduction and long-term maintenance in certain adults. | Expanded the injection presentation and dose landscape without changing every other label area. |
Primary sources include the original Wegovy approval package, 2022 pediatric supplement approval letter, 2024 cardiovascular indication notice, 2025 MASH approval notice, Wegovy tablet approval letter, 2026 safety-label communication, and Wegovy HD approval notice.
Supply and availability context
Section titled “Supply and availability context”Wegovy injection was part of a US semaglutide shortage that began in March 2022. FDA determined on February 21, 2025, that the national semaglutide injection shortage was resolved, while noting that intermittent localized supply disruptions could still occur as products moved through the supply chain.
That FDA shortage determination is a dated national record. It does not establish current stock at a particular pharmacy, launch status in another jurisdiction, insurance coverage, reimbursement, or price.
Safety and comparison boundaries
Section titled “Safety and comparison boundaries”The current US prescribing information includes a boxed warning concerning thyroid C-cell tumors observed in rodents and states that the relevance to humans has not been determined. It also contains contraindications, warnings, precautions, adverse reactions, interactions, and population-specific information that cannot be reduced safely to an ingredient- or class-level summary.
- Wegovy is not interchangeable with Ozempic or Rybelsus because the products share semaglutide.
- Injection and tablet labels do not have identical populations or indications.
- Wegovy HD does not apply automatically to pediatric, cardiovascular-risk, or MASH use.
- FDA approval does not establish launch, availability, coverage, reimbursement, affordability, or suitability for an individual.
- Cross-trial comparisons with Zepbound, Saxenda, or other products do not establish superiority without aligned populations, endpoints, durations, comparators, and label context.
- This product record does not provide personal medical, dosing, prescribing, or switching guidance.
Related records
Section titled “Related records”- Semaglutide for the active-ingredient record
- Novo Nordisk for company, pipeline, manufacturing, and ownership context
- GLP-1 receptor agonists for class-level relationships
- Clinical programs for STEP and related trial records
- Regulatory milestones for dated approval and label events
- Active ingredient vs brand vs product for product-identity distinctions
- Dose, formulation, and route for formulation interpretation
- Market access, coverage, and availability for access-status distinctions