Ozempic 2025: Evolving Indications, Competition, Regulation, and Real-World Realities

Ozempic has expanded beyond its original role in diabetes care to include cardiovascular and kidney protection. But with new approvals, real-world insights, and growing competition reshaping its future, in 2025, questions of safety, access, and next-generation therapies are continually being raised about GLP-1 treatments. 

wo injectors dosing pens for subcutaneous injection of antidiabetic medication or anti-obesity medicationImage credit: Alones/Shutterstock.com

How does Ozempic work?

Ozempic contains the active ingredient semaglutide, a glucagon-like 1 (GLP-1) receptor agonist (GLP-1RA) that mimics the activity of GLP-1, a natural hormone produced in the body that regulates blood sugar levels, reduces hunger, and slows digestion.1 Upon binding to the GLP-1 receptor, semaglutide treatment increases intracellular cyclic adenosine monophosphate (cAMP) levels, which subsequently activate protein kinase A (PKA), an enzyme involved in the synthesis and secretion of insulin.

By increasing insulin secretion after meals, Ozempic can reduce blood glucose and glucagon levels in patients with type 2 diabetes, thereby reducing their risk of complications like nerve damage, kidney disease, and cardiovascular events. Semaglutide also increases insulin sensitivity by activating the PI3K/Akt pathway and suppressing glucagon secretion by pancreatic α-cells to further support glycemic control.

Expanded clinical usage

In late 2017, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved Ozempic for treating type 2 diabetes in combination with diet and exercise. Since then, healthcare professionals have investigated other potential health benefits associated with Ozempic treatment to expand the clinical usage of this highly valuable therapy.

For example, GLP-1s are widely known for their ability to support weight loss by slowing digestion to extend satiety duration, subsequently leading to reduced food intake. Several studies have reported that semaglutide treatment can lead to an average weight loss of about 10-15% within one year at higher doses when administered at the 2.4 mg dose approved for obesity (marketed as Wegovy), which can significantly improve metabolic and cardiovascular health and reduce the risk of obese and overweight individuals developing chronic diseases like fatty liver disease and obstructive sleep apnea (OSA).1

Real‑World Effectiveness vs. Clinical Trials

In March of 2024, the FDA approved Wegovy, another semaglutide product, for the treatment of obese and overweight individuals diagnosed with cardiovascular disease.2 The FDA’s approval of semaglutide for this patient population was supported by results from the SUSTAIN-6 trial, which reported a 26% reduced risk in cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke associated with Ozempic treatment as compared to placebo.3

In January 2025, the FDA is anticipated to review and potentially expand Ozempic’s use for patients with type 2 diabetes and chronic kidney disease (CKD). The updated label would include reducing the risk of kidney failure, sustained declines in estimated glomerular filtration rate (eGFR), and cardiovascular-related death.4 In a randomized, double-blind, placebo-controlled trial of over 3,500 patients diagnosed with both type 2 diabetes and CKD, semaglutide treatment reduced the risk of major cardiovascular events and death due to any cause by 18% and 20%, respectively.4

Repurposing existing drugs is a powerful strategy that significantly reduces the cost and timeline of traditional drug development. For the treatment of polycystic ovarian syndrome (PCOS), a significant cause of infertility in women, researchers have explored the potential therapeutic utility of GLP-1R agonists like Ozempic in improving PCOS outcomes by effectively supporting weight loss, particularly in patients who have not responded to other lifestyle changes.

GLP-1R agonists can improve hyperinsulinism and hyperandrogenism by supporting weight loss while reducing total testosterone, insulin resistance markers, and total cholesterol levels.5 These studies remain investigational, and Ozempic is not currently approved for PCOS.

Safety Profile: Vision Risks & Adverse Events

Like many other drugs, Ozempic use can be associated with various side effects that become better tolerated over time. Some of the most common symptoms associated with Ozempic include nausea, vomiting, diarrhea, constipation, and abdominal discomfort. Other symptoms may include headaches, tachycardia, vertigo, fatigue, and mild injection site reactions like redness or itching.

Importantly, persistent nausea or vomiting can lead to kidney dysfunction, dehydration, and/or malnutrition.1 As a result, individuals with pre-existing gastrointestinal conditions like inflammatory bowel disease (IBD) should not be prescribed GLP-1RAs. Additional rare and potentially severe side effects can include pancreatitis, gallbladder problems, thyroid tumors, and muscle loss.

Concerns have also been raised about diabetic retinopathy and other vision risks. In the SUSTAIN-6 trial, patients with pre-existing retinopathy experienced worsening eye disease, highlighting the importance of ophthalmologic monitoring in at-risk populations.3

The Ozempic debate: New study reveals the good, the bad and the medically ugly

Video credit: globalnews/Youtube.com

Supply & Affordability: Post‑Shortage Landscape

Ozempic and other GLP-1RAs were placed on the U.S. FDA drug shortage list, which allows 503B facilities to produce drug products on a large scale without a patient-specific prescription.7 This decision allowed community pharmacies, telehealth companies, and other healthcare providers to provide patients with compounded semaglutide injections, often at more affordable prices than current Ozempic prices; however, the FDA has since removed these medications from its drug shortage list.7

In the United States, a monthly prescription of Ozempic can range from as little as $25 USD to about $1,200 USD without insurance. However, Ozempic is available in other countries for much lower monthly costs. This highlights the need for effective U.S. policy change to reduce high out-of-pocket patient costs. Regulators are also closely monitoring compounding practices and counterfeit risks, reflecting growing concerns about drug integrity and patient safety post-shortage.7

Competition and Next Generation Therapies

Ozempic is no longer the only dominant GLP-1 therapy on the market. Eli Lilly’s tirzepatide (marketed as Mounjaro for diabetes and Zepbound for obesity) has shown even greater weight-loss efficacy in head-to-head trials, averaging about 20% loss in some patients. Oral GLP-1 formulations, dual agonists targeting both GLP-1 and GIP, and investigational triple agonists are also advancing rapidly. These emerging therapies may capture market share and shape clinical decision-making in 2025 and beyond, particularly if they offer improved tolerability or lower costs.8

Economic Burden and the Long-Term Value of GLP-1 Therapy

Obesity is associated with a significant economic burden, particularly in the United States. Chronic diseases attributable to obesity and overweight cost an estimated $1.72 trillion in 2016, including $480.7 billion in direct healthcare spending and $1.24 trillion in lost productivity.6 Excess weight also increases the risk of numerous health conditions, some of which include type 2 diabetes, cancer, and cardiovascular disease, all of which further increase healthcare costs for this patient population.

A recent study found that treatment with 2.4 mg semaglutide, combined with diet and exercise, was more effective for weight loss than lifestyle changes, currently available obesity drugs, or no change. However, researchers still do not know how long patients will need to continue therapy to sustain weight loss and its related health benefits. 9

Lower disease burden leads to a wide range of economic benefits outside direct healthcare costs, such as increased productivity at work due to feeling healthier and, as a result, taking fewer sick days. Researchers also anticipate that Ozempic will increase patients’ quality of life, including self-esteem and mental health outcomes. Additionally, it could improve their overall shopping habits by selecting healthier options like casual dining restaurants rather than fast-food chains.6

Many patients prescribed Ozempic and other GLP-1 drugs may also experience a reduced desire for alcohol, tobacco, and other drugs like opioids. GLP-1 drugs are not currently approved to treat addiction; however, these side effects can similarly increase worker productivity and reduce the risk of non-communicable diseases often associated with these addictions.10

“Increased health and longevity could put more money in people’s pockets through things like lower healthcare costs, insurance premiums, groceries, and fewer trips to restaurants, in addition to potentially earning more over their lifetimes by staying in the workforce longer.” 6

References

  1. Wilding, J. P. H., Batterham, R. L., Calanna, S., et al. (2021). Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine, 384(11):989–1002. doi:10.1056/NEJMoa2032183
  2. U.S. Food & Drug Administration. (2024). FDA approves Wegovy to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight. [Online]. Accessed 26/9/25. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or.
  3. Marso, S. P., Bain, S. C., Consoli, A., et al. (2016). Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. New England Journal of Medicine 375(19):1834-1844. doi:10.1056/NEJMoa1607141
  4. Perkovic, V., Tuttle, K. R., Rossing, P., et al. (2024). Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. New England Journal of Medicine 391(2); 109-121. doi:10.1056/NEJMoa2403347.
  5. Pillarisetti, L., & Agrawal, D. K. (2025). Semaglutide: Double-edged Sword with Risks and Benefits. Archives of Internal Medical Research 8(1); 1-13. doi:10.26502/aimr.0189.
  6. Waters, H. & DeVol, R. (2018). The Health and Economic Costs of Excess Weight. Milken Institute. [Online]. Accessed 26/9/25. Available at: https://milkeninstitute.org/sites/default/files/reports-pdf/Mi-Americas-Obesity-Crisis-WEB.pdf
  7. U.S. Food & Drug Administration. (2025). FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain. [Online]. Accessed 26/9/25. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain
  8. Ludvik, B., Giorgino, F., Jódar, E., et al. (2025). Tirzepatide versus semaglutide once weekly in patients with obesity: the SURMOUNT-5 trial. New England Journal of Medicine, 392, pp.119–130. doi:10.1056/NEJMoa2412314
  9. Rubino, D.M., Greenway, F.L., Khalid, U., et al. (2021). Effect of continued weekly semaglutide vs placebo on weight loss maintenance in adults with overweight or obesity: the STEP-4 randomized clinical trial. JAMA, 325(14), pp.1414–1425. doi:10.1001/jama.2021.3224
  10. Hendershot, C. S., Bremmer, M., et al. (2025). Once-Weekly Semaglutide for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial. JAMA Psychiatry, 82(4):395–405. doi:10.1001/jamapsychiatry.2024.4789

Last Updated: Sep 26, 2025

Benedette Cuffari

Written by

Benedette Cuffari

After completing her Bachelor of Science in Toxicology with two minors in Spanish and Chemistry in 2016, Benedette continued her studies to complete her Master of Science in Toxicology in May of 2018. During graduate school, Benedette investigated the dermatotoxicity of mechlorethamine and bendamustine; two nitrogen mustard alkylating agents that are used in anticancer therapy.

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