Ubenimex is a well-characterized, oral, small-molecule, dual-inhibitor of aminopeptidase and leukotriene A4 hydrolase (LTA4H), the enzyme responsible for catalyzing the committed step in the formation of the proinflammatory mediator, LTB4. Ubenimex is approved in Japan as an adjunct to chemotherapy agents to extend survival and to maintain remission after treatment for acute non-lymphocytic leukemia in adults. Ubenimex has been used for over 25 years in Japan and remains commercially available through Nippon Kayaku. Ubenimex is not approved for any indication in the U.S. or Europe.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Designation to ubenimex for treatment of pulmonary arterial hypertension. Orphan Designation qualifies the sponsor of the drug for various development incentives. Orphan Designation also provides for a period of market exclusivity or protection against generic entry.
To learn more about the clinical trials that are underway and to find out if a study is enrolling patients in your area, please visit www.clinicaltrials.gov: NCT02664558 and NCT02736149.
Nippon Kayaku markets ubenimex under the trade name Bestatin™.