Drugs / EDP-305

Trials 10

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT03783897 Nov 2018 → Jun 2019 metabolic dysfunction-associated steatohepatitis Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT03748628 Oct 2018 metabolic dysfunction-associated steatohepatitis Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT03610945 Jul → Aug 2018 metabolic dysfunction-associated steatohepatitis Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT03213145 Jul → Aug 2017 metabolic dysfunction-associated steatohepatitis Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT03207425 Jun → Sep 2017 metabolic dysfunction-associated steatohepatitis Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT03187496 May → Jun 2017 metabolic dysfunction-associated steatohepatitis Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT02918929 Sep 2016 → Jun 2017 fatty liver disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 23 trials · 1 met primary · 1 missed
Phase 2 NCT04378010 Jan 2020 → Oct 2021 metabolic dysfunction-associated steatohepatitis Enanta Pharmaceuticals, Inc Terminated No outcome recorded Stop: Business
Phase 2 NCT03421431 Apr 2018 → Jun 2019 metabolic dysfunction-associated steatohepatitis Enanta Pharmaceuticals, Inc Completed Met primary
Phase 2 NCT03394924 Dec 2017 → Dec 2019 primary biliary cholangitis Enanta Pharmaceuticals, Inc Completed Missed primary

News releases announcing trial results or a regulatory action · 14

DateIssuerRelease
2021-10-04 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Provides Update on NASH FXR Agonist Programs enanta.com ↗
2020-08-28 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Presents New Data from its Hepatitis B and Non-Alcoholic Steatohepatitis Programs at the Digital International Liver Congress™ 2020 enanta.com ↗
Phase 2a ARGON-1 Study for FXR Agonist EDP-305 Targeting NASH, Showing Significant Alanine Transaminase and Liver Fat Content Reduction
2020-08-20 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Data Presentations at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020 enanta.com ↗
EDP-305, A Non-Bile Acid Farnesoid X Receptor (FXR) Agonist, Showed Statistically Significant Improvements in Liver Biochemistry and Hepatic Steatosis in the Phase 2a ARGON-1 Study
2020-05-06 Enanta Pharmaceuticals, Inc Results Enanta Announces Results of INTREPID Study of EDP-305 for the Treatment of Primary Biliary Cholangitis enanta.com ↗
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced topline results from its INTREPID Phase 2 study of EDP-305, a Farnesoid X receptor (FXR), in subjects with primary biliary cholangitis (PBC).
2019-11-11 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Poster Presentations at The Liver Meeting® 2019 enanta.com ↗
A NOVEL NON-BILE ACID FXR AGONIST EDP-305 PREVENTS PROGRESSION TO CIRRHOSIS IN THIOACETAMIDE-INDUCED MODEL IN RATS
2019-09-25 Enanta Pharmaceuticals, Inc Results Enanta Announces Positive Results of ARGON-1 Study of its lead FXR Agonist, EDP-305, for the Treatment of NASH enanta.com ↗
The study’s primary endpoint was achieved with a statistically significant ALT reduction of 28 U/L in the EDP-305 2.5mg arm versus 15 U/L in the placebo arm at week 12 (p=0.049).
2017-12-21 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Data Presentations at the 2018 NASH-TAG Conference enanta.com ↗
treatment with EDP-305 had a significant therapeutic effect on NASH progression in NASH mouse models, and resulted in decreased liver steatosis, hepatocyte ballooning, and total non-alcoholic fatty liver disease score (NAS).
2017-10-23 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Positive Phase 1 a/b Clinical Results for its Lead FXR Agonist, EDP-305 enanta.com ↗
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a chemistry-driven biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced positive results from its Phase 1 clinical study of EDP-305, Enanta’s lead FXR agonist for non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC).
2017-10-20 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals to Present New Preclinical Data on EDP-305, an FXR Agonist for NASH and PBC, at The Liver Meeting® 2017 enanta.com ↗
“A novel FXR agonist EDP-305 potently suppresses hepatic stellate cell activation and hepatic fibrosis in chronic mouse models of biliary and metabolic liver disease”
2017-04-19 Enanta Pharmaceuticals, Inc Results Enanta Announces New Preclinical Data on its FXR Agonist EDP-305 for Non-Alcoholic Steatohepatitis (NASH) and Primary Biliary Cholangitis (PBC) at The International Liver Congress™ 2017 enanta.com ↗
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced new data from its lead FXR agonist candidate EDP-305 for NASH and PBC.
2017-04-05 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Data Presentations at The International Liver Congress™ 2017 enanta.com ↗
Three poster presentations will demonstrate that EDP-305 is a potent Farnesoid X Receptor (FXR) agonist that has been shown to reduce fibrosis progression and improve non-alcoholic fatty liver disease (NAFLD) activity scores (NAS) in a variety of preclinical models.
2017-01-06 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Highlights of Business Overview and Update on its Research and Development Programs to be Presented at the 35th Annual J.P. Morgan Healthcare Conference enanta.com ↗
New in vivo data to be presented demonstrating EDP-305 improved pre-established liver injury and hepatic fibrosis in an MCD-induced model of steatohepatitis in mice1

All press releases naming this drug 17 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as EDP-305 “of Orally Administered EDP-305 to Evaluate” NCT02918929 ↗
11

“EDP-305” NCT04378010 ↗

NCT03394924 ↗

NCT03213145 ↗

NCT03610945 ↗

NCT03421431 ↗

NCT03207425 ↗

NCT02918929 ↗

NCT03187496 ↗

NCT04378010 ↗

NCT03748628 ↗

Show 1 more source

Action Activate “investigational novel FXR agonist, EDP-305” NCT04378010 ↗
Route Oral “orally administered doses of EDP-305” NCT02918929 ↗