CFDA Granted Approval of Phase II/III Clinical Trials for Imigliptin Hydrochloride
2016-08-04 15:25:37 Author:admin
        Phase II/ III Clinical Trials of Imigliptin Hydrochloride (KBP-3853) have been approved by CFDA; the Clinical Approval Numbers are 2016L05997 and 2016L06137.
 
        As we know, in Phase I study both single and multiple doses of Imigliptin Hydrochloride were safe and well tolerated in healthy volunteers and in Type 2 diabetes patients. Imigliptin Hydrochloride demonstrated good pharmacokinetic (PK) characteristics and exhibited dose-proportional plasma exposure. The potent and long duration inhibition of DPP-4 was validated in the PK/PD study. The results of Phase I study of Imigliptin Hydrochloride warranted its long-term safety and efficacy studies in Phase II/ III.
 
        Currently, the Imigliptin Hydrochloride team has completed the production of clinical trial drug product, as well as finalized the clinical protocols and the study sites. Phase II clinical trial of Imigliptin Hydrochloride will begin in the near future.
 
       The approval of Imigliptin Hydrochloride for the phase II/ III clinical trials represents another milestone in the SiHuan/ XuanZhu’s new drug discovery history. We enter into a new clinical stage of the development process, and we have many works remaining before us. It is still an urgent task for us to accelerate the clinical development, and to launch the drug product in the China market as soon as possible.
 

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