Deep Dive Moderate

GLP-1 Drugs: What Changed Through September 2026

A dated review of U.S. GLP-1 drug labels and evidence through September 2026: Ozempic's kidney indication, Wegovy tablets and MASH approval, the SOUL trial, and the FDA safety update.

PepCodex Research Team
6 min read
#glp-1 #semaglutide #tirzepatide #diabetes #weight-loss #fda-approved

GLP-1 evidence and U.S. labels, reviewed September 2026

This article was first published in September 2025 and updated on September 29, 2026. It tracks changes to selected U.S. product labels and a specific cardiovascular trial. For a lasting introduction to the drug class, read the GLP-1 receptor agonist guide.

A key distinction runs through every update: semaglutide activates the GLP-1 receptor, while tirzepatide activates both GIP and GLP-1 receptors. Zepbound’s label explicitly describes this dual action. A result for either ingredient, brand, or formulation should not be treated as a class-wide result. Wegovy label · Zepbound label

What changed in the labels?

Ozempic gained a kidney-related indication in 2025. Its May 2026 U.S. label includes reduction of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. That indication is for Ozempic under those conditions; it is not an approval for every semaglutide product or every person with kidney disease. Ozempic label, section 1

Wegovy injection gained an accelerated MASH indication in August 2025. The U.S. label specifies adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced F2–F3 fibrosis. Approval was based on improvements in MASH and fibrosis. A confirmatory trial is intended to determine whether those changes translate into clinical outcomes; continued approval may depend on verification of clinical benefit. This indication belongs to the injection, not the tablet. FDA approval explanation · Wegovy label, section 1

Wegovy tablets joined the injection in the U.S. label in December 2025. The June 2026 label lists the tablets for long-term weight reduction in specified adults and for cardiovascular risk reduction in adults with established cardiovascular disease and obesity or overweight. The injection has additional pediatric weight and MASH indications. “Oral semaglutide” is therefore too broad a description of an approved use without naming the product and population. Wegovy label, sections 1 and recent major changes

What did the SOUL trial add?

The 2025 SOUL randomized trial studied oral semaglutide versus placebo, in addition to standard care, in adults with type 2 diabetes and established atherosclerotic cardiovascular disease, chronic kidney disease, or both. SOUL tested oral semaglutide up to 14 mg, not the 25 mg Wegovy tablet described above. The primary composite outcome of cardiovascular death, nonfatal heart attack, or nonfatal stroke occurred in 12.0% versus 13.8% over the trial’s follow-up. Its confirmatory secondary outcomes did not differ significantly between groups. These are trial-population findings, not a prediction for every GLP-1 medicine or patient. Approved uses still come from each product’s current label.

How should the January 2026 safety update be read?

In January 2026, the FDA requested removal of the suicidal behavior and ideation warning from labeling of Saxenda, Wegovy, and Zepbound after its review found no increased risk associated with GLP-1 receptor agonist medicines. That review does not establish zero risk for every person or erase other warnings. The June 2026 Wegovy and August 2026 Zepbound labels still carry a boxed warning about thyroid C-cell tumors in rodents; human relevance is unknown. They also retain other product-specific precautions. FDA safety communication · Wegovy label · Zepbound label

Evidence grade: moderate for this cross-product synthesis. Current FDA labels are the primary authority for U.S. indications and warnings, and SOUL is a randomized trial for its defined population and endpoint. The longer-term clinical benefit behind Wegovy’s accelerated MASH indication remains subject to confirmation. This article is educational and does not provide medical advice or treatment recommendations.

Sources & Citations

Disclaimer: This article is for educational purposes only and does not constitute medical advice. The information presented is based on current research but should not be used for diagnosis, treatment, or prevention of any disease. Always consult a qualified healthcare provider before making health decisions.