Introducing Tirzepatide for Obesity: Approval Submission and Marketing Alliance Announcement in Japan


Eli Lilly Japan K.K. (headquartered in Kobe, Hyogo; led by Representative Director and President Simone Thomsen, hereinafter referred to as “Eli Lilly Japan”) and Mitsubishi Tanabe Pharma Corporation (headquartered in Osaka, Osaka; led by Representative Director Akihiro Tsujimura, hereinafter referred to as “MTPC”) have jointly announced the submission of an application for approval of tirzepatide (referred to as “the product”) to the Ministry of Health, Labour and Welfare. Additionally, the two companies have formed a strategic marketing alliance in Japan.

Under this alliance, Eli Lilly Japan will secure manufacturing and marketing approval for the product, while Mitsubishi Tanabe Pharma will handle its distribution and marketing activities post-approval. This arrangement mirrors their collaboration on the long-acting GIP/GLP-1 receptor agonist “Mounjaro® Subcutaneous Injection” (generic name: tirzepatide, hereinafter referred to as “Mounjaro”), which saw joint sales efforts commence in 2023. Both companies will collaborate on providing healthcare professionals with information about the product.

This partnership signifies a deepened commitment between Eli Lilly Japan and Mitsubishi Tanabe Pharma, aimed at advancing medical care for individuals living with type 2 diabetes and obesity in Japan. Tirzepatide stands out as the world’s first long-acting GIP/GLP-1 receptor agonist, acting on two receptors, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), through a single molecule.

Despite being based on the natural GIP peptide sequence, tirzepatide has been engineered to also bind to the GLP-1 receptor, providing selective and sustained action. Mounjaro® Subcutaneous Injection, introduced in Japan in April 2023 for type 2 diabetes, offers six dosage options ranging from 2.5 mg to 15 mg. Its approval in the U.S. for treating obesity disease in November 2023, marketed under the brand name Zepbound, further highlights its therapeutic versatility.

In Japan, obesity is characterized by excessive fat accumulation with a body mass index (BMI) of 25 or higher, while obesity disease encompasses health complications resulting from or associated with obesity, necessitating medical intervention for weight loss. Lifestyle factors, genetics, and environmental influences contribute to obesity and its related health issues, emphasizing the importance of addressing these conditions comprehensively.

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