Novo Nordisk wins a preliminary injunction against a Dutch compounded semaglutide nasal spray
A Dutch court barred a compounded semaglutide nasal spray after Novo Nordisk sued, adding a new drug delivery route and country to its worldwide crackdown on unapproved semaglutide products.
A court in the Netherlands has issued a preliminary injunction against a compounded semaglutide nasal spray, following a lawsuit filed by Novo Nordisk, the maker of Ozempic, Wegovy, and Rybelsus [1]. The ruling marks the first time the company's compounding enforcement campaign has reached a nasal formulation, expanding a legal fight that has mostly targeted injectable and sublingual versions of semaglutide sold outside the approved drug supply chain [1].
The case is part of what Novo Nordisk has called patient-safety litigation, an effort the company has pursued in multiple countries against pharmacies and compounders that make semaglutide products without regulatory approval [1]. Nasal and sublingual semaglutide have no approved dosing or bioavailability data anywhere in the world, meaning no regulator has verified how much of the drug such products actually deliver into the bloodstream or how that compares with approved injectable or oral versions [1]. The Dutch action is the latest entry in a timeline of Novo Nordisk legal and business moves that also includes a U.S. lawsuit against Eli Lilly over advertising claims and a request for a preliminary injunction in that separate case [1].
Details about the specific compounding pharmacy involved, the exact legal grounds cited by the Dutch court, or the duration of the injunction are not included in available reporting [1]. It is also not yet known whether the ruling will be appealed or whether it will influence enforcement actions in other European Union countries [1].
Why it matters for patients
For people using or considering semaglutide, the ruling underscores a basic safety gap: nasal and sublingual versions of the drug have not gone through the testing that Ozempic, Wegovy, and Rybelsus underwent before approval [1]. Without bioavailability data, there is no independent confirmation of how much active drug a nasal spray delivers, whether that amount is consistent from dose to dose, or how it might interact with the way the body absorbs semaglutide compared with an injection or the approved oral tablet [1].
This matters because dosing accuracy is central to how GLP-1 medications work and how side effects are managed. An unapproved product with unknown absorption could deliver too little of the drug to be effective, or an inconsistent amount that raises safety concerns, but the sources reviewed do not provide clinical data to quantify either risk [1]. Patients who have sought out compounded nasal or sublingual semaglutide, often as a lower-cost or more convenient alternative to injections, are the ones most directly affected by this legal action, since the injunction could restrict access to the product in the Netherlands while the case proceeds [1].
The broader pattern also signals that Novo Nordisk intends to keep pursuing legal action against compounders across jurisdictions and delivery methods, not just needles and vials [1]. That suggests other unapproved formats, such as sublingual drops or films, could face similar scrutiny in the future, though the sources do not name specific products or companies beyond the nasal spray at issue in this case [1].
What happens next
The available reporting does not specify a date for a final ruling in the Dutch case or describe next steps in the litigation [1]. It also does not indicate whether Novo Nordisk plans similar nasal-spray actions in other countries. Readers who use compounded semaglutide products of any kind may want to watch for follow-up statements from regulators or the company, since the current record leaves open questions about enforcement timing and scope [1].
Sources
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