U-NEURON BIOMEDICAL, a biotech company listed on Taiwan’s Emerging Stock Board, announced on April 3 that it has completed patient enrollment for the Phase I clinical trial of its oral investigational drug UA002, developed for the treatment of male erectile dysfunction. The drug is now set to advance into Phase IIa clinical trials.
According to the company, UA002 is a novel allogeneic amniotic fluid-derived stem cell therapy designed to treat patients with erectile dysfunction who do not respond to conventional oral medications. The primary objective of this clinical trial was to evaluate the safety and tolerability of intracavernosal injection of UA002 in patients with drug-refractory erectile dysfunction. A total of ten participants were enrolled in the Phase I study.
U-NEURON stated that, based on observations during the trial period and assessments using the IIEF-EF questionnaire—a standard efficacy measure approved by the U.S. Food and Drug Administration (FDA) for erectile dysfunction drugs—up to 70% of participants showed signs of improvement. Among those who responded to treatment, more than half achieved a change that met the minimal clinically important difference (MCID) threshold.
The company explained that patients who are unresponsive to oral medications typically suffer from nerve damage—such as complications following radical prostatectomy in prostate cancer patients—or from complex vascular and nerve impairments, such as those associated with diabetes-related erectile dysfunction. Preclinical animal studies have shown that UA002 exhibits a dual mechanism of action, promoting the repair of both nerve and vascular tissues.
According to a market research report by Precedence Research, the global erectile dysfunction drug market is projected to reach USD 3.19 billion by 2025. With an estimated compound annual growth rate (CAGR) of 8.69%, the market could expand to USD 6.74 billion by 2034. While current treatments are primarily oral medications, they still face limitations such as multiple side effects, incompatibility with antihypertensive drugs, and the looming expiration of original drug patents. The rise of generic PDE-5 inhibitors has intensified market competition, highlighting a strong demand for innovative therapeutic alternatives.
Resource: 永立榮性功能障礙新藥一期收案完成 將進入臨床二期
