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Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss Ozempic’s approval in a higher-dose oral form and lingering concerns over compounded drugs.
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!
In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, explore major updates in the evolving GLP-1 receptor agonist landscape, with a particular focus on oral semaglutide formulations, branding changes, and regulatory concerns surrounding compounded alternatives.
00:00:01 Intro
00:00:25 Oral Wegovy and oral Ozempic
00:03:04 Why Rybelsus didn't work
00:05:33 The importance of administration
00:06:56 Compounding drugs - the Hims and Hers drama
00:07:56 The danger of unregulated compound drugs
00:11:50 Outro
The discussion begins with the FDA approval of a higher-dose oral semaglutide formulation now branded as Ozempic for type 2 diabetes. Previously marketed as Rybelsus, the formulation itself remains bioequivalent, with no changes in efficacy, safety, or pharmacokinetics. The rebranding aligns oral and injectable Ozempic, simplifying clinical conversations and reducing prior authorization and coverage confusion. Similarly, oral Wegovy is now available for obesity management, reinforcing a unified naming convention: Ozempic for type 2 diabetes and Wegovy for obesity, regardless of route of administration.
The hosts note that while oral semaglutide has been available for several years, uptake of Rybelsus lagged behind expectations, in part due to limited brand recognition and confusion about its equivalence to injectable semaglutide. Early anecdotal experience suggests greater patient interest in “oral Ozempic,” highlighting the impact of naming clarity on real-world adoption. The simplified dosing structure of the newer formulations may further facilitate transitions during the upcoming rollout period.
Importantly, Isaacs and Bellini review key pharmacologic considerations. Oral semaglutide depends on the absorption enhancer SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) to protect the peptide from gastric degradation and promote systemic uptake. Administration remains strict: taken on an empty stomach with no more than 4 ounces of water, followed by a 30-minute interval before food, beverages, or other medications. Despite daily dosing, the drug retains a long half-life of approximately one week, meaning that temporary discontinuation—for example, prior to planned pregnancy—requires appropriate lead time. They emphasize that daily administration reflects absorption variability rather than a shorter pharmacologic duration.
The episode then pivots to safety concerns surrounding compounded oral semaglutide products. With GLP-1 shortages largely resolved, some telehealth companies—including Hims & Hers—have begun marketing lower-cost compounded oral versions. This has prompted legal action from Novo Nordisk, given that the proprietary SNAC technology is patented and critical to the drug’s validated bioavailability. The hosts caution that compounded oral formulations may lack regulatory oversight, standardized absorption data, and robust phase 1–4 clinical trial evidence. Without validated pharmacokinetics, patients risk receiving ineffective therapy—or potentially unsafe products—despite appealing lower price points.
The episode concludes with cautious optimism. While branding simplification and cost reductions represent meaningful progress in access and patient engagement, the hosts underscore the necessity of evidence-based prescribing and clinician-led patient education. As the GLP-1 therapeutic landscape continues to expand, maintaining safety, regulatory integrity, and pharmacologic rigor remains paramount.
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.
