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# Lilly Once-weekly Diabetes Injection Approved
- URL: https://www.fdaweb.com/lilly-once-weekly-diabetes-injection-approved/
- Published: 2022-05-13T12:00:00.000Z
- Updated: 2026-09-14T17:44:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151813

FDA has approved an Eli Lilly NDA for Mounjaro (tirzepatide), a once-weekly injection to improve blood sugar control in adults with Type 2 diabetes, as an addition to diet and exercise. “Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies,” an [agency release](http://email.prnewswire.com/ls/click?upn=1wail4kuE335JAITe4Fv8sh3b45qtZNufu6hsx-2Bkl7Z1RlwsjEiYGsM7Al8OZXkzBXGOJCTGfsSkULVff-2Fx0ir3z37BrrD-2BZbTE0J4-2Bv4zo-3DQwbn%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWV6qsUNCz-2FZxjAQ2dOyRjAblbfQGuz0Q8hx-2FiUhX3MKGRhyYqCBEOQhbyDDTn1jrg3pXi8JjcYwXZcQMObpz-2F0IUGX0Ne4GR57kT9LfYnzjmIJkwqViYglC-2BC3AQeIRIK8JtfRgNt2-2F-2BcVnyDn9-2BnodNQNiqlIqB6xJf3fW66Vfxeid3YWb-2Belx55G0kjYS9E0dKI6W7sU-2FHC82yVF10pOyRY6I2rMrhCOF-2FQWVG7Wf-2F5OZjDbFq7NDexaGQ-2F7Xh-2FJSWAWvNtcNt7e-2FptBoNeTkQ-3D-3D&ref=fdaweb.com) says.  

Mounjaro is described as a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control. “Three different doses of Mounjaro (5 milligrams, 10 milligrams and 15 milligrams) were evaluated in five clinical trials as either a stand-alone therapy or as an add-on to other diabetes medicines,” FDA says. “The efficacy of Mounjaro was compared to placebo, a GLP-1 receptor agonist (semaglutide) and two long-acting insulin analogs.”  

On average, patients who received the 15mg dose saw a lowering of their hemoglobin A1c (HbA1c) level by 1.6% more than placebo when used as stand-alone therapy, and 1.5% more than placebo when used in combination with a long-acting insulin, the agency says. “In trials comparing Mounjaro to other diabetes medications, patients who received the maximum recommended dose of Mounjaro had lowering of their HbA1c by 0.5% more than semaglutide, 0.9% more than insulin degludec and 1.0% more than insulin glargine,” it says.