Zepbound approved for obesity in Japan

MHLW backs Zepbound for patients unresponsive to lifestyle therapy

Eli Lilly Japan K.K. and Mitsubishi Tanabe Pharma Corporation have announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted manufacturing and marketing authorization for Zepbound (tirzepatide), a long-acting GIP/GLP-1 receptor agonist. The approval covers the treatment of obesity in patients who have not responded adequately to diet or exercise and who also present with hypertension, dyslipidemia, or type 2 diabetes mellitus. Eligibility is further defined by BMI thresholds.

What is Zepbound, and how does it work?

Zepbound is a long-acting dual agonist of GIP and GLP-1 receptors. It activates both using a single molecule based on native GIP peptide sequences, modified to bind to the GLP-1 receptor for prolonged action and weekly dosing.

Who is eligible for Zepbound treatment in Japan?

Zepbound is authorized for individuals with obesity who also have hypertension, dyslipidemia, or type 2 diabetes mellitus, and who do not respond adequately to diet or exercise. Patients must meet one of the following criteria:

• A BMI of ≥27 kg/m² with at least two obesity-related health conditions
• A BMI of ≥35 kg/m²

How is Zepbound administered?

Zepbound is administered once weekly via subcutaneous injection using Ateos, a single-use autoinjector device.

What dosages are available for Zepbound?

Zepbound is available in six dose standards: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg, allowing for flexible dosing based on patient condition.

Is Zepbound the same as Mounjaro?

Yes, Zepbound contains the same compound as Mounjaro, which is marketed by Eli Lilly Japan and Mitsubishi Tanabe Pharma for the treatment of type 2 diabetes mellitus.