VOLIXIBAT



NAME OF DRUG : VOLIXIBAT

ALSO KNOWN AS : SHP626

LABORATORY : SHIRE

STATUS AND ADVANCEMENT

Type of drug : (ASBT) inhibitor

Clinical trials advancement : Recruiting Phase 2b

The drug got the Fast Track Status granted by the FDA

Estimated time to market : 75 months.

LABORATORY ABSTRACT ON THE DRUG

SHP626 has been evaluated in preclinical and Phase 1 studies, in which the safety, tolerability and preliminary activity of SHP626 compared to placebo in healthy volunteers, as well as in overweight and obese volunteers, was assessed. The most common adverse events occurring in Phase 1 trials of SHP626 were gastrointestinal in nature, predominantly diarrhea. While this occurred in most patients, it was not considered serious. There was one serious adverse event reported that was considered related to SHP626, alanine aminotransferase elevation, that led to discontinuation of drug.

RECENT NEWS ON VOLIXIBAT

2016-07-29 : Shire receives FDA Fast Track for Volixibat on NASH with fibrosis

SOME PUBLICATIONS RELATED WITH VOLIXIBAT

SOME NASHBIOTECHS POINTS OF VIEW RELATED WITH VOLIXIBAT

October 2016 : NASH COMBOs ARE THE WAY


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