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Weight Loss Index

Semaglutide

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk and used across several prescription products. In the obesity-treatment industry, it is the active ingredient in Wegovy. It also appears in Ozempic and Rybelsus products associated with type 2 diabetes, so the ingredient name alone does not identify a product, indication, formulation, route, or regulatory status.

The US record reviewed here is current to July 23, 2026. Product labels can change; the linked FDA and DailyMed records should be checked before reusing indication, formulation, dose, safety, or availability claims.

Reference record

Section titled “Reference record”
Field Semaglutide record
Entity type Active ingredient
Drug class GLP-1 receptor agonist
Originator and principal commercial company Novo Nordisk
Obesity-market brand Wegovy
Adjacent diabetes-market brands Ozempic and Rybelsus
US obesity-market routes Subcutaneous injection and oral tablet
Major obesity-development program STEP
Important adjacent outcome programs SELECT cardiovascular outcomes and ESSENCE MASH development

Ingredient, brand, and product are different records

Section titled “Ingredient, brand, and product are different records”

Semaglutide identifies the active ingredient. Wegovy, Ozempic, and Rybelsus identify products with their own labels, formulations, strengths, routes, indications, and regulatory histories.

US product context Route Relationship to obesity-industry research
Wegovy injection Subcutaneous injection The principal semaglutide obesity product. Its current US label includes long-term weight reduction, cardiovascular-risk reduction in a defined adult population, and an accelerated-approval MASH indication with product- and population-specific scope.
Wegovy tablets Oral tablet An adult weight-reduction and cardiovascular-risk-reduction product approved under a separate NDA in December 2025. The tablet label should not be assumed to carry every indication or population included on the injection label.
Ozempic Injection and oral tablet products Type 2 diabetes products that share semaglutide but do not become obesity products merely because the ingredient is also used in Wegovy.
Rybelsus Oral tablet A type 2 diabetes product and an adjacent oral-semaglutide record. Its formulation and strengths are not interchangeable with other semaglutide tablets on a milligram-for-milligram basis.

The current DailyMed Wegovy label separates the indications and dosing of Wegovy injection from Wegovy tablets. The current DailyMed oral Ozempic and Rybelsus label likewise states that the oral products are not substitutable on a milligram-for-milligram basis.

Mechanism and formulation context

Section titled “Mechanism and formulation context”

Semaglutide belongs to the GLP-1 receptor agonist class. FDA labeling describes Wegovy as a GLP-1 receptor agonist and identifies semaglutide as its active ingredient. Mechanism-level grouping helps connect products and development programs, but it does not establish equal efficacy, safety, dosing, indications, or suitability across products in the class.

Formulation is part of the product identity. By July 2026, the US semaglutide record includes both injectable and oral products, including Wegovy formulations used in obesity-market contexts. Route and formulation therefore need to be recorded alongside the ingredient instead of inferred from the word “semaglutide.”

Company and commercial relationships

Section titled “Company and commercial relationships”

Novo Nordisk is the originator and central commercial company across the semaglutide portfolio. Its role connects the ingredient to Wegovy, Ozempic, Rybelsus, the STEP clinical program, manufacturing and supply records, and later regulatory expansions.

That company relationship should not be reduced to a generic “manufacturer” field. Depending on the product and record, industry research may need to distinguish developer, NDA applicant or holder, labeler, physical manufacturer, packager, distributor, and marketer. For example, FDA’s original Ozempic approval package identifies Novo Nordisk Inc. as the sponsor, while current DailyMed labels provide product-specific packager and marketing information.

Clinical-development map

Section titled “Clinical-development map”

Semaglutide’s obesity-development history is distributed across several programs rather than one trial.

Program or study Database relationship Interpretation boundary
STEP Connects semaglutide 2.4 mg development to weight-management populations and the Wegovy program. STEP 1, NCT03548935, was sponsored by Novo Nordisk and studied once-weekly subcutaneous semaglutide in adults with overweight or obesity. Results from one STEP trial should not be generalized to every population, formulation, dose, or indication.
SELECT, NCT03574597 Connects Wegovy’s cardiovascular-risk indication to a dedicated cardiovascular outcomes program in people with overweight or obesity and prior cardiovascular disease. A cardiovascular label claim is defined by the studied population and endpoint, not by weight reduction alone.
ESSENCE, NCT04822181 Connects Wegovy injection to the noncirrhotic MASH indication with moderate to advanced fibrosis. The US MASH indication received accelerated approval; continued approval may depend on confirmation of clinical benefit.

Specific trial outcomes belong in dated clinical-program records that preserve population, comparator, duration, endpoint definitions, and source context.

US regulatory history

Section titled “US regulatory history”
Date Event Why the event matters
December 5, 2017 FDA approved Ozempic injection under NDA 209637 for a type 2 diabetes indication. This is the initial US approval record for semaglutide, but it is not an obesity-product approval.
June 4, 2021 FDA approved Wegovy injection for chronic weight management in defined adult populations. The event established the main US obesity-market product record for semaglutide.
March 8, 2024 FDA added a cardiovascular-risk-reduction indication for Wegovy injection in adults with established cardiovascular disease and obesity or overweight. The label expansion connected the obesity product to a cardiovascular outcomes record with a defined population.
August 15, 2025 FDA granted accelerated approval to Wegovy injection for noncirrhotic MASH with moderate to advanced liver fibrosis in adults. The event added a liver-disease indication and an ongoing confirmatory-evidence requirement.
December 2025 FDA approved Wegovy tablets under NDA 218316 for adult weight reduction and cardiovascular-risk reduction. Semaglutide’s US obesity-market record expanded from injection-only to include an oral product with its own label scope.
March 19, 2026 FDA approved a 7.2 mg Wegovy injection dose, marketed as Wegovy HD, for weight reduction and long-term maintenance in certain adults. The event changed the dose and presentation landscape without making the higher dose applicable to every Wegovy indication or population.

Primary records include the original Ozempic approval package, the 2021 Wegovy approval notice, the 2024 cardiovascular indication notice, the 2025 MASH approval notice, the Wegovy tablet approval letter, and the 2026 Wegovy HD approval notice.

What not to infer

Section titled “What not to infer”
  • A semaglutide reference does not by itself identify Wegovy, Ozempic, Rybelsus, a route, a dose, or an indication.
  • A shared active ingredient does not make products or formulations interchangeable.
  • Approval in one product, population, indication, jurisdiction, or formulation does not automatically apply to another.
  • A clinical-program result does not establish the same outcome for every semaglutide product or use.
  • FDA approval is not the same as launch, local availability, insurance coverage, reimbursement, or uninterrupted supply.
  • This ingredient record does not provide personal treatment, prescribing, or switching guidance.
Section titled “Related records”