The Dangers of Compounded Oral GLP-1s

On February 9, 2026, Novo Nordisk announced that it had filed a lawsuit against Hims & Hers, alleging patent infringement over Hims’ compounded semaglutide products. The document goes on to suggest that these drugs are technically unapproved and therefore may be unsafe for consumers, particularly given that oral Wegovy is the only GLP-1 pill to receive approval from the US Food and Drug Administration.1,2

Diabetes Dialogue hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, sat down to discuss the controversy and the larger issue of compounded GLP-1 formulations.

Check out the full episode on oral GLP-1s here.

In this segment, the discussion focuses on the growing controversy surrounding compounded oral semaglutide products in the wake of resolved GLP-1 receptor agonist shortages. The speakers emphasize that prior supply constraints affecting both injectable and oral semaglutide formulations have largely been eliminated, with consistent access across doses now reported in routine clinical practice. Despite restored availability, new market entrants—including Hims & Hers—have introduced lower-cost oral semaglutide offerings, prompting swift legal action from Novo Nordisk.

Central to the dispute is the proprietary absorption enhancer (SNAC) required for effective oral semaglutide bioavailability. Oral delivery of GLP-1 receptor agonists presents substantial pharmacokinetic challenges, and the commercial formulation of Wegovy and related oral semaglutide products relies on highly specific absorption technology developed and patented by Novo Nordisk. The speakers underscore that this enhancer cannot be readily replicated without intellectual property and regulatory implications. As such, questions arise regarding what excipients or delivery mechanisms compounded versions are employing—and whether these have undergone any formal pharmacologic validation.

The conversation highlights the broader regulatory and safety concerns associated with compounded oral formulations. Unlike FDA-approved medications, which require extensive phase 1–4 clinical trial evaluation, compounded alternatives may enter the market without rigorous assessment of pharmacodynamics, pharmacokinetics, dose proportionality, or long-term safety. Given the inherent difficulty of achieving adequate gastrointestinal absorption of peptide-based therapies, the speakers raise the possibility that some compounded oral semaglutide products may offer minimal systemic exposure, effectively functioning as placebos. At worst, the use of untested absorption enhancers or excipients could introduce unanticipated toxicity.

At the same time, the speakers acknowledge strong patient demand for lower-cost GLP-1 therapies. They note substantial progress in price reductions compared with earlier list prices exceeding $1,000 per month, with current branded options beginning at considerably lower entry points. Nevertheless, they stress that cost-containment strategies must remain aligned with regulatory oversight and evidence-based standards.

The segment concludes with a cautionary message to clinicians and patients: while expanding access to obesity and metabolic therapies is critical, compounded oral GLP-1 formulations warrant skepticism in the absence of transparent safety and efficacy data. With commercial supply stabilized, the speakers advocate prioritizing FDA-approved therapies to ensure both therapeutic integrity and patient safety.

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 issues statement on illegal mass compounding and deceptive advertising by Hims & Hers. February 5, 2026. Accessed February 16, 2026. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916489

2. Novo Nordisk. Novo Nordisk takes legal action against Hims & Hers to protect patients from unsafe, knock-off Wegovy and Ozempic. February 9, 2026. Accessed February 16, 2026. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916493