Drugs / Seladelpar
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | UK (MHRA) | — | primary biliary cholangitis 3 | 2024-11-15 | “Seladelpar has also been accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).” gilead.com ↗ |
| Filed | EU (EMA) | — | primary biliary cholangitis 3 | 2024-11-15 | “Seladelpar has also been accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).” gilead.com ↗ |
| Filed | EU (EMA) | — | primary biliary cholangitis 3 | 2024-05-18 | “Seladelpar has also been accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).” gilead.com ↗ |
| Filed | UK (MHRA) | — | primary biliary cholangitis 3 | 2024-05-18 | “Seladelpar has also been accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA)” gilead.com ↗ |
| Filed | US (FDA) | — | primary biliary cholangitis 3 | — | “A new drug application for seladelpar was submitted to the FDA in December 2023.” gilead.com ↗ |
Trials 15
| 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 28 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07841977 | Oct 2026 → Jun 2028 expected | primary biliary cholangitis | Gilead Sciences | Not yet recruiting | No outcome recorded |
| 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 | Missed primary |
| Phase 2 | NCT02955602 | Nov 2016 → Sep 2018 | primary biliary cholangitis | Gilead Sciences | Completed | Met primary |
| Phase 2 | NCT02609048 | Nov 2015 → Jul 2016 | primary biliary cholangitis | Gilead Sciences | Terminated | Met primary |
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | Gilead Sciences | Results 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 | Results 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today shared new results from a post hoc analysis showing that Livdelzi ® (seladelpar) was associated with high and sustained rates of normalization of a key liver marker (ALP) in people living with primary biliary cholangitis (PBC). |
| 2025-11-07 | Gilead Sciences | Results Gilead’s Livdelzi® Demonstrates Sustained Efficacy in Primary Biliary Cholangitis (PBC), Offering Alkaline Phosphatase (ALP) Reduction, Itch Relief and Potential to Slow Disease Progression gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced new long-term data reinforcing the safety and efficacy profile of Livdelzi ® (seladelpar) for people living with primary biliary cholangitis (PBC). |
| 2025-05-07 | Gilead Sciences | Results Gilead’s Livdelzi® (Seladelpar) Demonstrated Consistent Efficacy and Safety Regardless of Prior Treatment History in New Data Presented at EASL 2025 gilead.com ↗
Another analysis provides evidence supporting that Livdelzi delivered clinically and statistically significant improvements in pruritus. |
| 2025-02-20 | Gilead Sciences | Regulatory Gilead’s Seladelpar Granted Conditional European Marketing Authorization for the Treatment of Primary Biliary Cholangitis gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. |
| 2024-12-13 | Gilead Sciences | Regulatory Gilead’s Seladelpar Receives Positive CHMP Opinion for Primary Biliary Cholangitis gilead.com ↗ |
| 2024-11-15 | Gilead Sciences | Results Gilead’s Livdelzi (Seladelpar) Demonstrated a Sustained Efficacy and Long-Term Safety Profile in Management of Primary Biliary Cholangitis gilead.com ↗
Additionally, 41% (15 out of 37) of participants achieved normalization of alkaline phosphatase (ALP) levels, a critical biomarker of liver function. |
| 2024-08-14 | Gilead Sciences | Regulatory Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA gilead.com ↗
The FDA approved Livdelzi under accelerated approval based on a reduction of ALP. |
| 2024-06-05 | Gilead Sciences | Results Gilead’s Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis gilead.com ↗
Results demonstrated rapid and sustained improvements in markers of cholestasis, including high rates of normalization of liver biomarkers and a clinically meaningful reduction in pruritus (itch). |
| 2024-05-18 | Gilead Sciences | Results Investigational Seladelpar Demonstrates Significant Improvements in Liver Disease Progression and Reduced Itching in Primary Biliary Cholangitis gilead.com ↗
Additional findings demonstrate that seladelpar can help reduce pruritus (itch) in people living with primary biliary cholangitis (PBC). |
All press releases naming this drug 11 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 16 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 NCT00701883 ↗ |
| Known as | RWJ-800025 | ChEMBL registry synonym — accepted as the source's own label CHEMBL230158 ↗ |
| Known as | SEL | “Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B” NCT07841977 ↗ |
| Action | Activate | “Peroxisome proliferator-activated receptor delta agonist” CHEMBL230158 ↗1“MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia” NCT00701883 ↗ |
| Modality | Small molecule | — CHEMBL230158 ↗ |
| Route | Oral | “orally, once daily” NCT02609048 ↗ |
| Target | PPARD | “Peroxisome proliferator-activated receptor delta agonist” CHEMBL230158 ↗ |