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 |