FDA approves Mounjaro (tirzepatide) for type 2 diabetes

Eli Lilly/Tirzepatide (Mounjaro / Zepbound)

The FDA approved Mounjaro on 13 May 2022, a once-weekly injection and the first drug that activates both GIP and GLP-1 receptors, for adults with type 2 diabetes. In SURPASS Phase 3 trials it lowered blood sugar (A1C) more than every comparator and led to greater weight loss.

• Tirzepatide: dual GIP/GLP-1 receptor agonist; first-in-class mechanism approved for diabetes.
• SURPASS trials: superiority over GLP-1 monotherapy (semaglutide), SGLT2i, DPP-4i and basal insulin.
• Weight loss on tirzepatide exceeded GLP-1 alone; mean weight reduction ~3 kg greater at highest dose.
• Dosing: 2.5 mg (starting), 5/10/15 mg (maintenance); titrated weekly for tolerability.