Otsuka announces preliminary results of Phase 3 data on tolvaptan

Otsuka Pharmaceutical Co., Ltd. (Otsuka) has released its preliminary results from an additional Phase 3 clinical trial of tolvaptan in adult patients with autosomal dominant polycystic kidney disease (ADPKD). Primary and key secondary endpoints were positive for tolvaptan vs. placebo in the trial that examined the efficacy and safety of tolvaptan.

“We are heartened by the recently released tolvaptan results and its potential to be the first drug approved in the U.S. to treat ADPKD,” said David Baron, Ph.D., PKD Foundation Chief Scientific Officer. “Otsuka and tolvaptan’s journey to an approved treatment remains uncertain, but we are pleased to hear that these top-line results appear to be favorable.”

The additional trial was completed to supply confirmatory data to the previous study to address the Complete Response Letter (CRL) issued by the U.S. Food and Drug Administration (FDA) in 2013 for a New Drug Application (NDA) for tolvaptan in the treatment of adults with ADPKD.

Results from the trial will be submitted for presentation at a nephrology medical congress in the second half of 2017.

Read the full press release from Otsuka.