Drugs / Seladelpar
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04950764 | Nov 2021 → Feb 2025 | primary biliary cholangitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT03369002 | Nov 2017 → May 2018 | — | Gilead Sciences | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT07305363 | May 2026 → Sep 2027 expected | non-neoplastic bile duct disorder | University of California, San Diego | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04024813 | Nov 2019 → Jan 2020 | primary sclerosing cholangitis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT03551522 | Apr 2018 → May 2019 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT02955602 | Nov 2016 → Sep 2018 | primary biliary cholangitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02609048 | Nov 2015 → Jul 2016 | primary biliary cholangitis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT02472535 | Apr 2015 → Feb 2016 | homozygous familial hypercholesterolemia | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00701883 | Aug 2007 → Aug 2008 | hyperlipidemia | Gilead Sciences | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06051617 | Sep 2023 → Aug 2030 expected | primary biliary cholangitis | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT06060665 | Sep 2023 → May 2026 | primary biliary cholangitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT04620733 | Apr 2021 → Aug 2023 | primary biliary cholangitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03602560 | Oct 2018 → Feb 2020 | primary biliary cholangitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03301506 | Dec 2017 → Nov 2028 expected | primary biliary cholangitis | Gilead Sciences | Active not recruiting | No outcome recorded |
Press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | Gilead Sciences | Gilead’s Livdelzi® (Seladelpar) Delivers Statistically Significant Composite ALP Normalization in Phase 3 IDEAL Trial in Primary Biliary Cholangitis (PBC) gilead.com ↗ |
| 2026-05-27 | Gilead Sciences | Phase 3 ASSURE Interim Data: Majority of People in the Study with ALP 1–1.67×ULN Achieved High and Sustained Composite ALP Normalization at 24 Months with Gilead’s Livdelzi (Seladelpar) gilead.com ↗ |
| 2025-10-23 | Gilead Sciences | Gilead to Showcase Interim Long-Term Efficacy Data for Livdelzi® (Seladelpar) in Primary Biliary Cholangitis (PBC) and Investigational Bulevirtide in Chronic Hepatitis Delta gilead.com ↗ |
| 2025-05-07 | Gilead Sciences | Gilead’s Livdelzi® (Seladelpar) Demonstrated Consistent Efficacy and Safety Regardless of Prior Treatment History in New Data Presented at EASL 2025 gilead.com ↗ |
| 2025-02-20 | Gilead Sciences | Gilead’s Seladelpar Granted Conditional European Marketing Authorization for the Treatment of Primary Biliary Cholangitis gilead.com ↗ |
| 2024-12-13 | Gilead Sciences | Gilead’s Seladelpar Receives Positive CHMP Opinion for Primary Biliary Cholangitis gilead.com ↗ |
| 2024-11-15 | Gilead Sciences | Gilead’s Livdelzi (Seladelpar) Demonstrated a Sustained Efficacy and Long-Term Safety Profile in Management of Primary Biliary Cholangitis gilead.com ↗ |
| 2024-08-14 | Gilead Sciences | Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA gilead.com ↗ |
| 2024-06-05 | Gilead Sciences | Gilead’s Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis gilead.com ↗ |
| 2024-05-18 | Gilead Sciences | Investigational Seladelpar Demonstrates Significant Improvements in Liver Disease Progression and Reduced Itching in Primary Biliary Cholangitis gilead.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Seladelpar | “A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis.” PMID 35367282 ↗ Mar 2022 |
| Known as | MBX-8025 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02472535 ↗ |
| Known as | RWJ-800025 | ChEMBL registry synonym — accepted as the source's own label CHEMBL230158 ↗ |
| Action | Activate | “MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia” NCT00701883 ↗1“Peroxisome proliferator-activated receptor delta agonist” CHEMBL230158 ↗ |
| Modality | Small molecule | — CHEMBL230158 ↗ |
| Route | Oral | “orally, once daily” NCT02609048 ↗ |
| Target | PPARD | “Peroxisome proliferator-activated receptor delta agonist” CHEMBL230158 ↗ |