Latest FDA Updates and Research on Ozempic, Mounjaro, and Zepbound

The FDA made critical changes in 2025 for popular medications like Ozempic, Mounjaro, and Zepbound. Key updates include a halt on compounded versions, new approvals for kidney and sleep apnea benefits, and ongoing safety monitoring for thyroid and vision risks. Recent research confirms powerful effects, with some patients achieving over 20% weight loss and significant heart protection.

Key Takeaways

• The FDA has halted sales of compounded Ozempic and Mounjaro, declaring official shortages over.
• Zepbound is now approved to treat obstructive sleep apnea, a first for this drug class.
• New research confirms significant cardiovascular benefits and strong weight loss results, especially with tirzepatide.
• Patients must be aware of serious safety warnings, including risks for thyroid tumors and gastrointestinal issues.
• Discuss affordable options and a monitoring plan with your doctor, focusing on new benefits and potential risks.

What are the latest FDA updates on Ozempic, Mounjaro, and Zepbound this year?

The FDA has been active in 2025, making several key decisions that affect patients using GLP-1 drugs. A significant move was to end the sale of off-brand Ozempic and other compounded GLP-1 drugs, declaring official shortages over.

The grace period for compounded tirzepatide, the active ingredient in Mounjaro and Zepbound, ended in March. The final deadline for compounded semaglutide, found in Ozempic and Wegovy, was in May 2025 . This change cuts off access to more affordable versions that many patients relied on.

In a separate action, the FDA issued warning letters to Eli Lilly, the maker of Mounjaro and Zepbound, concerning a promotional video. The agency stated the video was misleading because it omitted important risk information about the drugs . The letters emphasize that promotional communications must present serious risks in a truthful and non-misleading way.

The FDA has also approved new uses for these medications. Ozempic now has a new label to reduce the risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease . Wegovy, the weight-loss version of semaglutide, received accelerated approval for a liver condition called metabolic dysfunction-associated steatohepatitis (MASH) .

How do new research studies support tirzepatide and semaglutide for diabetes and weight loss?

Recent research solidifies the role of these medications as powerful tools for managing type 2 diabetes and obesity. A 2025 head-to-head trial published in the New England Journal of Medicine found that tirzepatide (Zepbound) led to significantly greater weight loss than semaglutide . On average, tirzepatide achieved a 20.2% reduction in body weight, compared to 13.7% for semaglutide .

For glycemic control in type 2 diabetes, the SURPASS-2 trial showed that tirzepatide (Mounjaro) also outperformed semaglutide 1 mg, leading to greater reductions in HbA1c over 40 weeks .

The following table summarizes the key effectiveness data for these drugs.

Real world studies show that while clinical trial results can be dramatic, outcomes in everyday practice are more varied. Average weight reduction in routine care is often a more modest 2-8% after one year, influenced by factors like adherence and individual patient response .

What FDA safety warnings should patients know about GLP-1 drugs like Ozempic and Mounjaro?

Patient safety is paramount, and the FDA highlights several serious risks associated with this class of drugs. All GLP-1 and GIP medications, including Ozempic, Mounjaro, and Zepbound, carry a boxed warning about the risk of thyroid C-cell tumors, based on rodent studies . They are contraindicated for people with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) .

Other serious risks requiring medical attention include :

• Acute Pancreatitis: Inflammation of the pancreas.
• Gallbladder Problems: Such as gallstones.
• Severe Gastrointestinal Reactions: Including nausea, vomiting, diarrhea, and constipation. In rare cases, these can be severe .
• Acute Kidney Injury: Often linked to dehydration from GI side effects.
• Diabetic Retinopathy: Patients with a history of this eye condition should be monitored, as rapid improvements in blood sugar can sometimes aggravate it .
• Suicidal Behavior and Ideation: Zepbound's label includes warnings about this risk .

Recent studies have also investigated other potential safety signals. Research in 2024 and 2025 has linked semaglutide (Ozempic, Wegovy) to an increased risk of a rare eye condition called NAION, which can lead to vision loss . Another analysis of FDA adverse event reports in 2025 suggested a potential association between GLP-1 drugs and thyroid cancer, though this does not prove causation and more research is needed .

Why did the FDA approve Zepbound for sleep apnea, and what does the research show so far?

In December 2024, the FDA approved Zepbound (tirzepatide) for the treatment of obstructive sleep apnea (OSA) in adults with obesity, making it the first drug in its class with this indication . This approval was a significant milestone because it officially recognized the medication's ability to treat a serious condition closely linked to obesity.

The decision was based on clinical trials demonstrating that patients with OSA who were treated with tirzepatide showed meaningful improvements in the apnea-hypopnea index, which measures the number of breathing pauses during sleep. The studies also reported higher rates of OSA remission compared to those taking a placebo . This provides a new, effective treatment option for a condition that affects many people with obesity.

Are there cardiovascular benefits in recent Ozempic and Mounjaro research findings?

Yes, a growing body of research confirms that these drugs offer significant heart protection, especially for people with existing cardiovascular risk factors. A major real-world study published in Nature Medicine in November 2025 analyzed insurance data and found that both semaglutide (Ozempic) and tirzepatide (Mounjaro) significantly reduce the risk of major cardiovascular events like heart attack and stroke in people with type 2 diabetes .

The study showed semaglutide reduced the risk of stroke and heart attack by 18% compared to sitagliptin, another diabetes drug. Tirzepatide lowered the combined risk of stroke, heart attack, and death by 13% compared to an older GLP-1 drug . The lead researcher noted that the benefits appear early and seem to extend beyond weight loss alone .

These findings complement earlier outcomes that led to formal FDA label expansions. Ozempic is now approved to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established CVD . Wegovy is similarly approved for cardiovascular risk reduction in adults with obesity or overweight and established CVD .

How should patients talk to their doctors about the latest GLP-1 FDA guidance and research updates?

Having an informed conversation with your healthcare provider is key to making the best decisions for your health. Here is a simple framework to guide your discussion.

First, prepare for your appointment. Make a list of your specific health goals, whether for weight loss, blood sugar control, or managing a related condition like sleep apnea or heart disease. Note down any questions or concerns you have about the medications, especially regarding the latest safety warnings .

During the conversation, you can ask specific questions based on the latest updates:

• "Given the FDA's halt on compounded versions, what are my affordable options for staying on this treatment?"
• "Based on the new research, how can this medication help protect my heart and kidneys?"
• "I've read about the boxed warning for thyroid tumors and other risks. What symptoms should I watch for, and how do my personal risks factor into this?"
• "With the new approval for sleep apnea, is this drug a suitable option for treating my condition?"

Finally, create a shared monitoring plan. Discuss a realistic titration schedule to manage gastrointestinal side effects . Agree on what new or worsening symptoms (like vision changes, severe abdominal pain, or persistent vomiting) should prompt an immediate call to your doctor or a trip to the emergency room.