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Takeda Obtained New Drug Application Approval of "Leuplin® PRO for injection kit 22.5 mg" in Japan for the Treatment of Prostate Cancer and Premenopausal Breast Cancer

September 28, 2015

Osaka, Japan, September 28, 2015 – Takeda Pharmaceutical Company Limited (“Takeda”) (TSE: 4502) today obtained New Drug Application approval of "Leuplin® PRO for injection kit 22.5 mg" (generic name: leuprorelin acetate), which is the 24 week depot of "Leuplin®", a treatment for prostate cancer and premenopausal breast cancer, from the Japanese Ministry of Health, Labour and Welfare.

Created and developed by Takeda, Leuplin is an LH-RH agonist that consistently stimulates the pituitary gland, resulting in suppressed production of male/female hormones. Leuplin is used as a treatment for hormone-dependent diseases such as prostate cancer and premenopausal breast cancer, and it is currently available in the United States, Europe, and Asia.

Leuprorelin acetate was initially approved as a once-daily injection administration in the United States in 1985, but Takeda has applied multiple innovations, based on its expertise in drug formulation technology, to turn it into a sustained-release microcapsule depot formulation, enabling it to maintain stable blood concentration levels over a long period of time. At present, both 4 week and 12 week formulations are marketed in Japan.

This approval is based on the results of two clinical phase III multicenter, randomized, open label, comparative studies evaluating safety, efficacy, pharmacokinetics, hormone dynamics, and other factors in patients with prostate cancer and those with premenopausal breast cancer. Leuplin PRO becomes the world's first product to obtain approval for the treatment of premenopausal breast cancer for 24 week depot.

By delivering this new treatment for both prostate cancer and premenopausal breast cancer, Takeda looks forward to further contributing to meeting the needs of patients and healthcare professionals. 


Product Name Leuplin® PRO for injection kit 22.5 mg
Generic Name leuprorelin acetate
Indications Prostate cancer and premenopausal breast cancer
Dosage and administration

The usual adult dose is 22.5mg of Leuprorelin Acetate which is subcutaneously 
administrated once every 24 weeks.

When using Leuplin® PRO, it should be used after suspending it completely by transferring the whole quantity of the vehicle into the powder part, by pressing the plunger rod, with the injection needle held upward, with caution against foaming.


About Takeda

Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

Additional information about Takeda is available through its corporate website, www.takeda.com.



Tsuyoshi Tada
Takeda Pharmaceutical Company Limited
E-mail: [email protected]