History

May 1998 Was co-founded by Kyowa Hakko Kogyo Co., Ltd. and Dr. Matsumoto with the aim of “supporting the speedy development of drugs required by patients”.
Aug 2003 Entered into a co-development agreement with PsychoGenics, Inc. for eltoprazine.
May 2004 Entered into an agreement with bene pharmaChem GmbH & Co. KG for co-development of Pentosan PolySulfate (PPS).
Jan 2007 Started Phase I clinical trial of PPS in Japan
Mar 2009 Started pharmacokinetic study of eltoprazine in Japanese subjects in the U.S.
Apr 2010 Started Phase II clinical trial of PPS for OsteoArthritis (OA) in Japan.
Sep 2010 Entered into a license agreement with Chong Kun Dang Pharmaceutical Corp. for PPS in Korea
Jun 2011 Was selected as a developer of betaine, a development support product for the Ministry of Health, Labour and Welfare’s unapproved drug development support program
Sep 2012 Entered into a license agreement with Orphan Europe SARL to acquire exclusive rights to develop and to commercialize betaine in Japan.
Mar 2012 Received orphan drug designation for betaine from the Ministry of Health, Labour and Welfare
Mar 2012 Started Phase III clinical trial of betaine in Japan
Mar 2013 Applied to domestic manufacturing and marketing approval of Cystadan® bulk powder (generic name: betaine) for the treatment of homocystinuria
Apr 2013 Obtained first-class marketing authorization
Jan 2014 Was approved for manufacturing and marketing of Cystadan® bulk powder
May 2014 Commercially launched Cystadan® bulk powder
Oct 2014 Started Phase II clinical trials of PPS for HTLV-1 Associated Myelopathy (HAM)
Sep 2015 Started Pediatric safety study of PPS for MucoPolySaccharidosis (MPS)
Dec 2017 Started Phase II clinical trial of PPS for MPS and Mucolipidosis
Apr 2019 Signed a license agreement with Icahn School of Medicine at Mount Sinai for PPS (indication: MPS)
May 2020 Started domestic Phase III clinical trial of Cholic Acid
Aug 2020 Received orphan drug designation cholic acid from the Ministry of Health, Labour and Welfare