Approval for manufacture and sale of Reclast® in Japan

September 28, 2016
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma today obtained approval for the manufacture and sale of Reclast® for intravenous (i.v.) infusion 5 mg (generic name: zoledronic acid, development code: AK156) in Japan for the treatment of osteoporosis. Reclast® is an osteoporosis drug capable of a year-long treatment with once a year i.v. administration.

Zoledronic acid (Reclast®) is a bisphosphonate developed by Novartis Pharma AG (Basel, Switzerland) and was first approved in 2007 in the US and EU followed by approval in over 115 countries worldwide.

Asahi Kasei Pharma received rights to develop and market Reclast® in Japan through an agreement concluded in June 2010, and filed an application for approval in September 2015.

Reclast® will provide a new treatment option in Japan for patients with osteoporosis.


Product name
Reclast® for i.v. infusion 5 mg
Generic name
Zoledronic acid
Dosage and administration
The usual adult dosage is 5 mg administered by intravenous infusion over not less than 15 minutes, once per year.

Reclast® is a trademark of Novartis Pharma AG.