Bukwang Pharmaceutical will enter into phase 3 clinical trials of Lurasidone, a new drug to cure schizophrenia it imported from Japan’s Sumitomo Dainippon Pharma.
The Ministry of Food and Drug Safety (MFDS)식품의약품안전처 approved Tuesday the phase 3 clinical trial plan of Lurasidone (HCl (SM-13496) in clinical test product name).
Bukwang부광약품 will conduct the trial at Seoul National University Boramae Medical Center 서울보라매병원 on schizophrenic patients who show acute symptoms of mental illness, evaluating the efficacy and safety of Lurasidone through randomized, double-blind, placebo-controlled test.
Lurasidone is a therapy developed by Sumitomo Dainippon Pharma to cure atypical schizophrenia and bipolar disorder. It works as an antagonist to block Dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptor, acts in part to some serotonin 5-HT1A receptor and shows little affinity to Histamine H1 and muscarine M1 receptor.
The drug won the approval in the United States and Canada as a single treatment to cure schizophrenia and type-1 bipolar disorder for adults and teenagers, and as the supplementary therapy of Lithium and valproic acid. It also has won approvals to cure schizophrenia of adults in EU, Switzerland, Australia, Taiwan, Russia, Singapore, Thailand, and Hong Kong.
In Korea, Bukwang signed an exclusive licensing contract for developing, marketing, selling and distributing the therapy, and will put it to market after getting approvals.
Lurasidone recorded the sales of $1 billion in the North American market from April 2015 to March 2016, and an additional $900 million in nine months from April to December last year, showing fast sales growth.
Bukwang’s cooperative ties with Sumitomo Dainippon have become solidified further with the recent contract, following its importing and marketing of Lonasen from its Japanese partner in 2005, the Korean company said.