Trial Profile
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Status:
Recruiting
Phase of Trial:
Phase III
Latest Information Update: 06 Mar 2024
Price :
$35
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At a glance
- Drugs Seladelpar (Primary)
- Indications Primary biliary cirrhosis
- Focus Adverse reactions; Registrational
- Acronyms ASSURE
- Sponsors CymaBay Therapeutics
- 04 Mar 2024 According to a CymaBay Therapeutics media release, the MAA application includes data from global Phase 3 RESPONSE study, The application is further supported by data from the Phase 3 ENHANCE study, the long-term open label ASSURE study, Phase 2 studies, pre-clinical studies and includes chemistry, manufacturing, and controls data.
- 04 Mar 2024 According to a CymaBay Therapeutics media release, the Marketing Authorization Application (MAA) for seladelpar, for the treatment of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid), has been validated and will now be reviewed by the European Medicines Agency (EMA).
- 12 Feb 2024 According to a CymaBay Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar for the management of primary biliary cholangitis including pruritus in adults without cirrhosis or with compensated cirrhosis who are inadequate responders or intolerant to ursodeoxycholic acid.The NDA includes data from across Phase 3 RESPONSE, ENHANCE and ASSURE study and prior Phase 2 studies.