Shinshin Pharmaceutical Develops World's First Insomnia Treatment Drug... "Phase 1 Clinical Trial IND"

Transdermal drug delivery platform company Shinshin Pharmaceutical is set to commence clinical trials for one of its major pipelines, ‘SS-262 (insomnia treatment)’.

Shinshin Pharmaceutical announced on the 16th through a public disclosure that it has completed the submission of the Phase 1 clinical trial application (IND) for SS-262 to the Ministry of Food and Drug Safety. SS-262 is the world’s first transdermal insomnia treatment. Since it enhances the drug delivery effect of existing treatments and resolves side effects, it is expected to have high market potential upon commercialization.

The purpose of this clinical trial is to evaluate the pharmacokinetic properties and safety of SS-262 in 60 healthy adults. Subjects will be divided into two groups at domestic clinical trial institutions and administered either SS-262 or a control drug. The Phase 1 trial is expected to take approximately 12 months.

Shinshin Pharmaceutical maximized the drug delivery effect of SS-262 by applying TDDS (Transdermal Drug Delivery System) technology. SS-262 features reduced lag time and improved absorption rate compared to existing treatments, prevents drug crystallization, and significantly enhances stability.

Shinshin Pharmaceutical began developing SS-262 in 2021 through a national bio-medical technology commercialization project by the Seoul Business Agency. During the preclinical trials under this national project, the company successfully established technological entry barriers by registering a total of three domestic and overseas patents related to SS-262.

A Shinshin Pharmaceutical official stated, “Existing melatonin-based treatments have limitations such as short half-life and low efficiency, but SS-262, which applies TDDS technology, has the advantage of maintaining a consistent blood concentration over a long period.” He added, “We will accelerate development with the goal of completing Phase 1 clinical trials by next year.”

He further added, “Since we have also obtained overseas patents and export product approvals, global exports will significantly expand upon the development of SS-262.”

Shinshin Pharmaceutical recorded its highest-ever performance through the third quarter. While sales of existing pharmaceuticals and global exports continue to rise, the company plans to accelerate growth through new drug development. Based on TDDS technology, Shinshin Pharmaceutical is developing various new drugs including UIP-620 (treatment for overactive bladder).