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# Fast Track for Shire Liver Fibrosis Drug
- URL: https://www.fdaweb.com/fast-track-for-shire-liver-fibrosis-drug/
- Published: 2016-07-29T12:00:00.000Z
- Updated: 2026-09-14T21:19:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136341

FDA has granted Shire a fast track designation for SHP626 (volixibat), an investigational drug for treating adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter, a protein that it says is primarily responsible for recycling bile acids from the intestine to the liver. NASH is a chronic liver disease for which there are currently no approved drugs for treatment.

The designation was based on data from preclinical and Phase 1 studies. Shire says it will initiate a randomized, placebo-controlled, double-blind Phase 2 study to evaluate the safety, tolerability and efficacy of three doses of volixibat over 48-weeks in adult patients with NASH. It will be conducted in the U.S., Canada and the United Kingdom.