| Indication or Program | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|
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Primary Biliary Cholangitis Incomplete responders (ALP>1.67xULN) |
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Primary Biliary Cholangitis Incomplete responders (ALP>1.67xULN) |
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Primary Biliary Cholangitis Partial responders (ALP 1 to 1.67xULN) |
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Primary Biliary Cholangitis Clinical outcomes in patients with compensated cirrhosis (Child Pugh A & B) |
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CB8025-21838 |
Primary Biliary Cholangitis Pharmacokinetic study in patients with hepatic impairment (Child Pugh A, B & C) |
IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) (IDEAL)
RecruitingTo Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)
View IDEAL Trial for PBC
AFFIRM Clinical Trial: For Seladelpar in Subjects with PBC and Compensated Cirrhosis
RecruitingTo Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
View AFFIRM Trial for PBC
PBC with Hepatic Impairment Clinical Trial: For Seladelpar in Subjects with PBC and Hepatic Impairment
RecruitingThe Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
View PBC with Hepatic Impairment Trial Information
ASSURE Clinical Trial: For Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
RecruitingAn Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
View ASSURE Trial for PBC
RESPONSE Clinical Trial: For Seladelpar in Subjects with PBC and an Inadequate Control to or an Intolerance to UDCA
CompletedTo evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo
View RESPONSE Clinical TrialRequests for Expanded Access
This Policy for Requests for Expanded Access to Investigational Drugs describes the principles and procedures that CymaBay will follow when considering requests by licensed physicians for use of CymaBay’s investigational drugs outside of clinical trials.
View Expanded Access PolicyEnrollment
For more information on enrollment in our current clinical trials, please contact us or visit clinicaltrials.gov for location information.
The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.