Ardelyx and Kyowa Hakko Kirin have entered into a license agreement that gives Kyowa Hakko Kirin exclusive rights to develop and commercialize Ardelyx’s lead investigational product, tenapanor, for the treatment of cardiorenal diseases in Japan. 

Tenapanor is an oral, minimally systemic NHE3 inhibitor that is in Phase 3 development in the United States for the treatment of hyperphosphatemia in patients with end-stage renal disease who are on dialysis.

Under the terms of the agreement, Ardelyx will receive a $30 million upfront payment and is eligible to receive additional development and commercialization milestones worth up to $130 million. Ardelyx is also eligible to receive high-teen royalties throughout the term of the agreement. Kyowa Hakko Kirin will have the exclusive rights to develop, market and commercialize tenapanor for cardiorenal diseases and conditions associated with them, including hyperphosphatemia, in Japan.

“Kyowa Hakko Kirin is an established leader in the development of cardiorenal products and an ideal partner to develop tenapanor for such diseases in the Japanese market,” said Mike Raab, president and chief executive officer of Ardelyx. “This agreement represents the first collaboration under our strategy of evaluating collaborative opportunities to bring tenapanor to patients and physicians across all potential indications as efficiently as possible.”