Zydena® under test, drawing attention as the world’s first ‘portal hypertension cure’
Zydena® (Udenafil), a cure for erectile dysfunction of Dong-A Pharmaceutical will be subject to phase II
clinical trial in Europe. By estimation, the number of portal hypertension cases will reach some 6 million in the
U.S., Europe and Japan by 2010, but, there is no salient cure for it yet in sight. Upon successful completion of
the clinical trial, Zydena® will receive credit for being the world’s first portal hypertension cure and
innovative new drug. As only beta blocker (a kind of adrenergic inhibitor) is now tried on an off-label use
basis to reduce hemorrhage to some extent in portal hypertension cases, a new drug that can treat variceal
hemorrhage critical to some conditions effectively over time needs to be developed. The phase II clinical trial
that is now being conducted by the German licensing partner Dr. Falk will test the efficacy and safety of
Zydena® on 200 portal hypertension cases in Europe. President Park, Dong-Hyun of Dong-A Pharmtech that
is a subsidiary of Dong-A Pharmaceutical in charge of global Zydena® development program stated, “The
clinical trial is even more noteworthy as it enables us to evaluate the potential of Zydena® as a cure for
portal hypertension with Dr. Falk in Europe leading the global pharmaceutical industry,” and added, “We plan to
further try it for treatment of other conditions as well such as benign prostatic hyperplasia and pulmonary
hypertension.” A source at Dr. Falk commented, “Partnership with Dong-A Pharmaceutical regarding the
development of Zydena® as a cure for portal hypertension in Europe is very important for Dr. Falk as well,”
and added, “Successful completion of the ongoing clinical trial will allow for verification of the potential of
Zydena® as an effective cure for portal hypertension.”