Timeline

2017

January, 2017.  FDA grants orphan drug designation to L-citrulline for prevention of clinical sequelae of acute lung injury induced by cardiopulmonary bypass in pediatric patients.

2016

July, 2016. L-citrulline pivotal Phase III trial initiated in July, 2016.

June, 2016. Asklepion Pharmaceuticals, LLC strategically divests its liquid formulation of ursodeoxycholic acid to Retrophin, Inc.

March, 2016. Asklepion Pharmaceuticals, was awarded a 2016 Rare Impact Award by the National Organization for Rare Disorders (NORD).

January, 2016. Asklepion Pharmaceutical’s first product Cholbam®(cholic acid) is listed in the U.S. Food and Drug Administration’s Novel Drug Summary for 2015.

2015

April, 2015. Sale of Cholbam® (cholic acid) to Retrophin, Inc.

March 17, 2015. Cholbam® (cholic acid) approved by the FDA for the treatment of bile acid synthesis defects.

March 17, 2015. FDA grants Asklepion a Rare Pediatric Disease Priority Review Voucher as provided under section 529 of The FDCA. Only 6 have been awarded since 2009.

2014

April, 2014. The European Commission granted a marketing authorization for Cholbam® (cholic acid).

2013

November, 2013. NDA application submitted to the FDA for cholic acid.

2010

September, 2010. Phase IB Trial of I.V. L-citrulliine (CIT-002-01).

April, 2010. Phase III Trial for cholic acid (CAC-001-01).

2006

October, 2006. Asklepion in-licensed Ursofalk® (ursodeoxycholic acid) suspension from Dr. Falk Pharma GmbH.

July, 2006. Asklepion in-licensed I.V. L-citrulliine from Vanderbilt University.

July, 2006. Asklepion Pharmaceuticals, LLC founded in Baltimore, MD to develop cholic acid for inborn errors of bile acid metabolism.