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Article source: Pharmaceutical Guanlan
According to the latest announcement by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, Sumitomo Dainippon Pharma's Class 1 new drug SEP-363856 tablets have obtained four clinical trials with implied approval, and it is planned to develop the treatment of schizophrenia.
Public information shows that SEP-363856 is an antipsychotic drug with a brand-new mechanism of action, and it is in phase 3 clinical phases worldwide.
In May 2019, the US FDA has granted the drug candidate a breakthrough therapy designation for the treatment of schizophrenia.
Screenshot source: CDE official website
Schizophrenia is a chronic and serious mental illness that affects more than 23 million people worldwide.
The positive symptoms of patients include hallucinations, delusions, and confusion, while negative symptoms include emotional apathy, social withdrawal, and impairment of cognitive functions such as memory and decision-making.
SEP-363856 is a new type of trace amine-related receptor 1 (TAAR1) agonist with serotonin 1A (5-HT1A) agonist activity.
It is intended to be developed for the treatment of schizophrenia and other mental diseases.
Unlike clinically common antipsychotic drugs that generally work by binding dopamine D2 receptors and serotonin 2A (5-HT2A) receptors, SEP-363856 does not bind to dopamine D2 receptors or 5-HT2A receptors.
Therefore, SEP-363856 is expected to bring an innovative therapy to patients with schizophrenia.
At present, the therapeutic effect of SEP-363856 has been initially verified in clinical trials.
According to research data published in the New England Journal of Medicine (NEJM) in April 2020:
Compared with placebo, after 4 weeks of treatment, in terms of the Positive and Negative Symptom Scale (PANSS, a medical scale used to measure the severity of symptoms in patients with schizophrenia), the flexible dose of SEP-363856 once a day ( 50-75 mg) treatment showed a statistically significant and clinically significant improvement; at the same time, according to the evaluation of the clinical overall impression-severity scale (CGI-S, clinical evaluation of mental illness), patients receiving SEP-363856 treatment The overall severity of the disease has also improved; in addition, a 6-month open-label extension study showed that SEP-363856 has good safety and tolerability.
Note: The original text has been deleted
 Center for Drug Evaluation (CDE) of China National Medical Products Administration.
Retrieved June 01, 2021, from http:// England Journal of Medicine Publishes Pivotal Results Evaluating Sunovion's SEP-363856 for the Treatment of Schizophrenia.
Retrieved April 15, 2020, from https://news.