Novo Nordisk Gains European Approval for Semaglutide 7.2 mg, Submits Application to FDA

On February 17, 2026, the European Commission approved a semaglutide injection dose of 7.2 mg for adults living with obesity after a clinical trial displayed substantial body weight reduction on average. Additionally, parent company Novo Nordisk has submitted an application for semaglutide 7.2 mg to the US Food and Drug Administration (FDA), indicating its potential arrival in the US.1

Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the efficacy and practicality of a 7.2 mg semaglutide formulation.

Check out the full episode on injectable GLP-1 receptor agonists here.

In this segment, Isaacs and Bellini discuss recent regulatory developments involving high-dose semaglutide for obesity management, highlighting the European approval of a 7.2 mg injectable formulation. This represents a substantial increase from the current maximum 2.4 mg dose approved in the United States under Wegovy. The speakers clarify that this higher-dose formulation is indicated exclusively for chronic weight management and is distinct from Ozempic, which remains approved for glycemic control in type 2 diabetes. The distinction between obesity and diabetes indications is emphasized, particularly given ongoing public and clinical confusion surrounding semaglutide branding and dosing.

The panel notes that the 7.2 mg dose has been submitted to the FDA, with a potential approval anticipated later this year. European authorization signals that safety evaluations have been completed at this higher dose, which the speakers interpret as reassuring from a pharmacovigilance standpoint. Clinically, the higher dose appears to confer incremental weight loss beyond that achieved with 2.4 mg, potentially offering an enhanced therapeutic option for patients with overweight and obesity who require additional efficacy. The discussion frames this as part of a broader expansion of GLP-1 receptor agonist–based obesity treatment, underscoring the meaningful impact these agents have had for patients who have historically struggled with limited pharmacologic options.

Beyond efficacy, the speakers examine practical considerations related to drug delivery systems and real-world use. Current U.S. Wegovy formulations are dispensed as single-use pens designed for a defined treatment interval. It remains unclear whether the 7.2 mg formulation, if approved in the United States, would maintain this format or transition to a multi-dose, adjustable (“multi-click”) pen. This uncertainty leads to a broader caution regarding dose manipulation strategies. Some patients may attempt to extend higher-dose pens by administering smaller doses over prolonged periods to reduce costs. However, the speakers emphasize that such practices raise concerns regarding medication stability, sterility, and potency.

They note that existing semaglutide pens are typically stable at room temperature for approximately 30 days and are engineered for a limited number of injections. Extending use far beyond the intended timeframe—potentially for several months—could compromise efficacy or introduce contamination risk. While limited short-term extension may occur in practice, prolonged off-label use of a single pen is not supported by available stability data.

Overall, the conversation underscores both the therapeutic promise of higher-dose semaglutide in obesity care and the importance of adhering to approved dosing, storage, and administration guidelines as new formulations emerge.

Editor’s Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

References

1. Novo Nordisk. Novo Nordisk A/S: The European Commission approves more effective dose of injectable Wegovy for adults with obesity; clinical study showed people lost about 21% of their body weight on average. BioSpace. February 17, 2026. Accessed February 24, 2026. https://www.biospace.com/press-releases/novo-nordisk-a-s-the-european-commission-approves-more-effective-dose-of-injectable-wegovy-for-adults-with-obesity-clinical-study-showed-people-lost-about-21-of-their-body-weight-on-average