Healthcare Jan 17, 2022 10:21 AM (GMT+8) · EqualOcean
Yiouda health on January 17, Suoyuan biology announced today that the U.S. FDA approved the international phase IIB clinical trial ind application of its first in class new drug db104 (liafensine) against refractory depression (TRD). Therefore, Suoyuan biology will launch this international phase IIB clinical trial to evaluate the safety and efficacy of db104 in patients with TRD. This clinical trial is the third international clinical trial carried out by Suoyuan biology after db102 lymphoma international phase III and glioma clinical phase III. it will also be the first clinical trial under the guidance of biomarkers in the field of central nervous system (CNS). Db104 is the first new drug in the world, which can specifically inhibit the reuptake of serotonin, norepinephrine and dopamine, which play an important role in depression. Liafensine was originally developed by BMS / aMRI. In more than ten completed clinical trials, db104 showed good safety and did not stop the drug due to adverse events. In 2017, Suoyuan biology obtained the rights of research, development, production and sales of liafensine in the world.