FDA APPROVES ORAL GLP-1
Eli Lilly and Co. of Indianapolis nearly has a corner on the GLP-1 market. Their GLP-1, tirzepatide, has been a huge success, and in a brilliant marketing ploy has entered the market in two “formulations.” Lilly’s tirzepatide indicated for the treatment of diabetes is called MOUNJARO. Lilly’s tirzepatide indicated for weight loss is called ZEPBOUND. Two tirzepatides for two separate indications, and they are the exact same drug! So, uncle Eli has a huge market share of the GLP-1 business, and the future looks bright.
Business is only going to get better, however, because of the recent FDA approval of a new oral GLP-1 formulation, orforglipron. This is a real coup for Lilly’s and is certain to increase revenues and the stock price. I’ve written about orforglipron in past articles because an oral formulation of GLP-1 has been a long-anticipated improvement. It’s introduction is a welcome change.
Oral orforglipron is indicated for “use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.” It can be taken any time of day with or without food or water restrictions, and is available in six different strengths.
In clinical trials, orforglipron was associated with “reductions in cardiovascular risk markers, including waist circumference, non-HDL cholesterol, triglycerides, and systolic BP.” Adverse effects are largely GI and include “nausea, constipation, vomiting, dyspepsia, and abdominal pain….headache, fatigue, and hair loss.”
Orforglipron is a new molecular formulation. The FDA expedited approval because it fit into the need for addressing “critical national health priorities.” In other words, it’s approval was felt to be very important in the battle against obesity in the U.S. Weight loss totals with orforglipron are not as impressive as with Zepbound or semaglutide preparations, but the oral dosing form is preferable to a lot of patients. The cost is significantly less, too.
For awhile, prescriptions for orforglipron will exceed other GLP-1’s. Whether it becomes the preparation of choice will depend on how effective it is at causing weight loss and how much adverse effects interfere with its desirability. Time will be the deciding factor.
Reference: Tucker ME. FDA Ok’s Orforglipron for Weight Management Medscape 2026 April 1.



