Seladelpar Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Seladelpar has been evaluated across multiple clinical trials and observational programs spanning Phase 1 through Phase 3, primarily targeting chronic liver disorders including primary biliary cholangitis, nonalcoholic steatohepatitis, primary sclerosing cholangitis, hepatic impairment, and post-liver transplantation ischemic cholangiopathy. Sponsored by pharmaceutical developers such as Gilead Sciences alongside academic institutions including the University of Leipzig and the University of California, San Diego, these studies display a broad spectrum of recruitment statuses, ranging from completed and actively recruiting to terminated and upcoming.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06051617	RECRUITING	Primary Biliary Cholangitis	Gilead Sciences	2023-09-07	PHASE3
NCT03301506	ACTIVE_NOT_RECRUITING	Primary Biliary Cirrhosis	Gilead Sciences	2017-12-12	PHASE3
NCT07305363	NOT_YET_RECRUITING	Liver Transplant; Complications; Ischemic Cholangiopathy	University of California, San Diego	2026-05	PHASE2
NCT06060665	COMPLETED	Primary Biliary Cholangitis	Gilead Sciences	2023-09-05	PHASE3
NCT04950764	COMPLETED	Primary Biliary Cholangitis; Compensated Cirrhosis; Hepatic Impairment	Gilead Sciences	2021-11-16	PHASE1
NCT04620733	COMPLETED	Primary Biliary Cholangitis	Gilead Sciences	2021-04-21	PHASE3
NCT03602560	COMPLETED	Primary Biliary Cholangitis	Gilead Sciences	2018-10-01	PHASE3
NCT04024813	TERMINATED	Primary Sclerosing Cholangitis	Gilead Sciences	2019-11-12	PHASE2
NCT03551522	TERMINATED	NASH - Nonalcoholic Steatohepatitis	Gilead Sciences	2018-04-30	PHASE2
NCT03369002	COMPLETED	Hepatic Impairment	Gilead Sciences	2017-11-27	PHASE1
NCT02609048	TERMINATED	Primary Biliary Cirrhosis (PBC)	Gilead Sciences	2015-11-04	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-11)

Check the Seladelpar product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Seladelpar acts as a potent and selective agonist of peroxisome proliferator-activated receptor-delta (PPAR-δ), which modulates key transcriptional networks involved in lipid oxidation, insulin sensitivity, and inflammatory signaling. By enhancing metabolic homeostasis and reducing hepatic lipotoxic lipid accumulation, this receptor activation mitigates hepatocellular stress and inflammatory tissue damage, providing therapeutic benefit in clinical conditions such as primary biliary cholangitis and nonalcoholic steatohepatitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).