Shinshin Pharmaceutical Receives IND Approval for Phase 3 Clinical Trial of Next-Generation Overactive Bladder Treatment ‘UIP-620’

Shinshin Pharmaceutical announced on the 16th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for the phase 3 clinical trial plan (IND) of 'UIP-620,' the first transdermal treatment for overactive bladder in Korea.

UIP-620 is characterized by significantly improved dosing intervals and reduced side effects compared to existing oral treatments. Shinshin Pharmaceutical developed UIP-620 based on its proprietary TDDS (transdermal drug delivery system) technology. In phase 1 clinical trials, it was confirmed that sufficient blood concentration was consistently maintained, leading to exemption from phase 2 trials.

The phase 3 clinical trial will be conducted on 686 overactive bladder patients at institutions including Seoul National University Bundang Hospital. Shinshin Pharmaceutical plans to evaluate the efficacy and safety of UIP-620 at 2, 6, and 12 weeks after administration, aiming to demonstrate the superiority of UIP-620 compared to placebo.

A Shinshin Pharmaceutical representative stated, “UIP-620 is the first transdermal treatment for overactive bladder attempted in Korea. Since overactive bladder mainly affects elderly patients, the market potential is expected to be very large upon commercialization of a treatment with dosing intervals improved by more than three times.”

He added, “We plan to advance TDDS technology during the commercialization process of UIP-620 and accelerate the development of additional new drug pipelines such as SS-262. Through the development of new drugs for various aging-related diseases including insomnia and overactive bladder, as well as sarcopenia treatments, we will diversify indications and maximize profit margins.”

Overactive bladder is caused by muscle and nerve function decline, hormonal changes, and other factors, and is an aging-related disease with increasing prevalence due to the growing elderly population. Anticholinergics are mainly used for drug treatment of overactive bladder patients, but they have side effects such as dry mouth and an increased risk of dementia. The company explained that it aims to target the domestic and international overactive bladder treatment markets by developing a new treatment that maximizes therapeutic effects and dosing convenience while improving side effects compared to existing oral formulations.

This content was produced with the assistance of AI translation services.