NASH candidate drug obtained FDA fast track certification
Terns pharmaceuticals (China) announced on 16th that it’s candidate drug for NASH indication, TERN-201 (SSAO inhibitor), has obtained the fast track certification of the US Food and Drug Administration (FDA) for the treatment of Nash indications. Terns has recently completed the phase I clinical study of TERN-201, which shows that oral administration of TERN-201 in healthy subjects is well tolerated and no obvious safety finding is found. In the study, each dose of TERN-201 showed a strong targeting effect and achieved a near complete inhibition of SSAO activity in plasma, and the inhibitory activity lasted for one week after single or repeated administration.
Nash (nonalcoholic steatohepatitis) is a kind of metabolic stress fatty liver disease, which is caused by nonalcoholic fatty liver disease and develops into a serious state. Further development is cirrhosis and Hepatocarcinoma. Preclinical studies have shown that NASH is the latest stage of NAFLD that can be prevented, reversed or delayed by drug therapy.
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