Vonafexor (EYP001) Clinical Trials

Size	Price	Qty
5mg	USD 427

Clinical Trials

Vonafexor (EYP001) has been evaluated across multiple Phase 1 and Phase 2 clinical trials sponsored primarily by Enyo Pharma, alone or alongside PRA Health Sciences. These studies assess its therapeutic potential in non-alcoholic steatohepatitis (NASH/MASH), chronic hepatitis B virus infection, chronic kidney disease, Alport syndrome, and healthy adult subjects, including Phase 2a safety and efficacy trials in NASH and proof-of-concept research in Alport syndrome. With statuses spanning completed, actively recruiting, and terminated, these trials reflect ongoing clinical development across metabolic, viral, and renal indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06939816	TERMINATED	Chronic Kidney Disease Stage 2; Chronic Kidney Disease Stage 3; Metabolic Dysfunction-Associated Steatohepatitis	Enyo Pharma	2025-07-01	PHASE2
NCT07251153	RECRUITING	Healthy Adult Male and Female Volunteers	Enyo Pharma	2025-10-28	PHASE1
NCT06425055	COMPLETED	Alport Syndrome	Enyo Pharma	2024-08-01	PHASE2
NCT03812029	COMPLETED	Non-alcoholic Steatohepatitis	Enyo Pharma	2019-01-30	PHASE2
NCT03976687	Completed	NASH - Nonalcoholic Steatohepatitis\|Healthy	Enyo Pharma	2019-06-11	Phase 1
NCT03272009	COMPLETED	Hepatitis B, Chronic	Enyo Pharma	2017-09-21	PHASE1
NCT03469583	COMPLETED	Hepatitis B, Chronic	Enyo Pharma	2018-02-12	PHASE1
NCT03110276	COMPLETED	Healthy	Enyo Pharma	2016-08	PHASE1
NCT03320616	Completed	Hepatitis B Chronic	Enyo Pharma\|PRA Health Sciences	2017-02-10	Phase 1
NCT03110276	Completed	Healthy	Enyo Pharma\|PRA Health Sciences	2016-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-04-23)

Check the Vonafexor (EYP001) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vonafexor acts as a selective, second-generation agonist of the farnesoid X receptor (FXR/NR1H4), binding to the nuclear receptor to modulate transcriptional cascades involved in bile acid synthesis, lipid metabolism, and inflammatory signaling pathways. By repressing hepatic lipogenesis and fibrotic gene expression while promoting metabolic regulation, this pharmacological action provides therapeutic utility in clinical evaluations for non-alcoholic steatohepatitis, chronic hepatitis B, and chronic renal disorders.

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>).