With the recent resolution of shortages for GLP-1 medications and their removal from the FDA drug shortage list, medications like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), the U.S. Food and Drug Administration (FDA) has ended temporary policies that allowed compounding of these drugs. State-licensed pharmacies were required to cease compounding tirzepatide by February 18, 2025, and outsourcing facilities by March 19, 2025. For semaglutide, the deadlines are April 22 and May 22, 2025, respectively. This action is intended to protect public safety by eliminating access to potentially unsafe, unapproved compounded formulations now that the commercial supply has stabilized.
GLP-1 Medicare Drug Negotiation Price List
In January 2025, the Centers for Medicare and Medicaid Services (CMS) announced the inclusion of GLP-1 receptor agonists – specifically semaglutide-based medications Ozempic, Wegovy and Rybelsus – in the second cycle of the Medicare Drug Price Negotiation Program, as per the Inflation Reduction Act.
Negotiations with manufacturers are scheduled throughout 2025, with the newly negotiated prices set to take effect in 2027. This initiative aims to reduce out-of-pocket costs for Medicare beneficiaries and address the high expenditures associated with these medications. Notably, CMS will treat all formulations of semaglutide – regardless of brand name, dosage form or approved indication – as a single product for negotiation purposes, potentially leading to more uniform and substantial price reductions across these therapies.
GLP-1 receptor agonists, widely used for managing type 2 diabetes and obesity, represented over $14 billion in Medicare Part D spending from November 2023 to October 2024, underscoring their significant financial impact on the program.
Expanded Indications and Emerging Uses For GLP-1 Receptor Agonists
As of April 2025, GLP-1 receptor agonists continue to evolve beyond their original use in type 2 diabetes and obesity management. Most notably, the FDA recently approved semaglutide (Ozempic) for reducing the risk of kidney disease progression, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease — making it the first GLP-1 to receive this indication. The approval was based on results from the FLOW trial, which showed significant renal and cardiovascular benefits (Novo Nordisk, 2025). Eli Lilly’s investigational oral GLP-1, orforglipron, is also generating significant attention. In Phase 3 trials, it demonstrated substantial weight loss and improved glycemic control in patients with type 2 diabetes. Unlike earlier oral agents, orforglipron does not require fasting and is expected to be submitted for FDA approval for weight management by the end of 2025 (Business Insider, 2025; Axios, 2025).
GLP-1s are also in development for several novel therapeutic areas. Clinical trials are evaluating their efficacy in treating non-alcoholic steatohepatitis (NASH), polycystic ovary syndrome (PCOS), and neurodegenerative conditions such as Alzheimer’s disease. Preliminary research even suggests a potential role in reducing addictive behaviors related to alcohol and substance use (NFP, 2024; BioSpace, 2025). In addition to expanded indications, pharmaceutical companies are developing next-generation therapies that combine GLP-1 activity with other mechanisms. For example, CagriSema – a combination of semaglutide and cagrilintide – has shown enhanced weight loss efficacy in clinical trials. These advances indicate a broadening scope for GLP-1 therapies across metabolic, renal, neurological and behavioral health domains.
Sources:
- Katie Kindelan. “Compound Versions of Weight-Loss Drugs Will Soon No Longer Be Allowed, FDA Rules,” ABC News, 2025.
- Nathan Bomey. “Eli Lilly Stock Soars on Encouraging Results for Daily Weight-Loss Pill,” Axios, 2025.
- Nathan A. Beaver, et al. “GLP-1 Drugs: FDA Removes Semaglutide from Drug Shortage List,” Foley & Lardner LLP, 2025.
- Juliette Cubanski, et al. “A New Use for Wegovy Opens the Door to Medicare Coverage for Millions of People with Obesity,” KFF, 2024.
- Grace Halsey. “Lilly’s Oral GLP-1 Orforglipron Shows Significant A1c and Weight Reductions in Phase 3 Trial,” Patient Care Online, 2025.
- “GLP-1 Pipeline Update: February 2025,” Prime Therapeutics, 2025.
- Alivia Kaylor. “FDA Winds Down GLP-1 Compounding Policies,” TechTarget Pharma Life Sciences, 2025.
- U.S. Food and Drug Administration. “FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize,” FDA, 2025.
- U.S. Food and Drug Administration. “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss,” FDA, 2025.
- U.S. Congressional Research Service. “Medicare Coverage of GLP-1 Drugs,” CRS, 2025.
- Kelly Tyko and Nathan Bomey. “A Daily Weight-Loss Pill Could Transform GLP-1 Boom,” Axios, 2025.
- Tristian Manalac. “7 Indications for GLP-1s Beyond Weight Loss,” BioSpace, 2024.
- Gabby Landsverk. “Weight Loss In a Pill? Eli Lilly Just Took a Big Step Closer to Making It Happen,” Business Insider, 2025.
- “Expanded Indications and Future Outlook for GLP-1 Medications,” NFP, 2024.
- “FDA Approves Ozempic® (Semaglutide) as the Only GLP-1 Ra to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults with Type 2 Diabetes and Chronic Kidney Disease,” Novo Nordisk, 2025.
- Wikipedia Contributors. “Cagrilintide/Semaglutide,” Wikipedia, 2025.
- Centers for Medicare and Medicaid. “HHS Announces 15 Additional Drugs Selected for Medicare Drug Price Negotiations in Continued Effort to Lower Prescription Drug Costs for Seniors,” CMS, 2025.
- Jonathan Gardner. “Medicare Will Negotiate Novo’s GLP-1 Drug Price. Here’s What That Means for Ozempic, Wegovy,” BioPharma Dive, 2025.
