Is Orforglipron legal in Japan?

PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. Among GLP-1-based medicines, only Wegovy and Zepbound carry a Japanese obesity indication. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).