The NP101 project is a class 1.1 chemical small molecule new drug project developed with Irritable Bowel Syndrome with Diarrhea (IBS-D) as the indication. At present, a randomized, double-blind, placebo-controlled and multicenter clinical trial is being conducted to evaluate the clinical efficacy and safety of NP101 capsule in the treatment of IBS-D.
Phase Ⅱ/Ⅲ clinical trials have been completed in the early stage of NP101, have proved its effectiveness and safety. At present, complementary double-blind, multicenter Phase III clinical trials are being carried out. NP101 will be the third new IBS-D drug in the world and the first in China, with great market potential.
This clinical trial study was conducted according to the guiding principles of the European Drug Administration on clinical evaluation of IBS-D drug treatment in June 2013 and the guiding principles of the US FDA in 2012, referring to the clinical trial design of similar drugs, combining the characteristics of this drug and relevant laws and regulations. In the steady advancement of supplementary clinical trial research and other related research work, there are a huge number of people with IBS-D and IBS-D-like symptoms who urgently need effective drug treatment, and we are more aware of the market potential of the project.
IBS-D has become a global epidemic. At present, the prevalence rate in China is slightly lower than that in Europe and America, but it is increasing year by year. The prevalence of mental stress in special occupations such as military personnel and medical staff is higher. Mental and psychological factors and dietary factors are the main risk factors. IBS-D seriously reduces patients’ quality of life. IBS-D’s direct medical expenses (including diagnostic examination, medical treatment and hospitalization expenses) and indirect medical expenses are very high, while patients’ absenteeism due to illness also causes indirect economic losses.