Sparsentan (PS-433540, RE-021) Clinical Trials

Size	Price	Qty
2mg	USD 270

Clinical Trials

Numerous clinical trials, spanning Phase 1 through Phase 4, evaluate sparsentan for proteinuric renal diseases, including IgA nephropathy, focal segmental glomerulosclerosis, Alport syndrome, and post-transplant glomerular conditions. Late-stage studies focus on its long-term safety and efficacy in reducing protein excretion and preserving renal function. Featuring both completed and actively recruiting studies, this research is supported by industry sponsors like Travere Therapeutics, Inc. in collaboration with academic centers such as Brigham and Women's Hospital and the University of Edinburgh.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04663204	RECRUITING	Immunoglobulin A Nephropathy; Kidney Diseases; Glomerulonephritis, IGA; Glomerulonephritis; Autoimmune Diseases; Immune System Diseases	University of Leicester	2020-12-10	PHASE2
NCT05003986	RECRUITING	Focal Segmental Glomerulosclerosis; Minimal Change Disease; Immunoglobulin A Nephropathy; IgA Vasculitis; Alport Syndrome	Travere Therapeutics, Inc.	2021-08-12	PHASE2
NCT07219121	ACTIVE_NOT_RECRUITING	Proteinuria; Immunoglobulin A (IgA) Nephropathy; Focal Segmental Glomerulosclerosis; Kidney Transplant	Travere Therapeutics, Inc.	2025-10-07	PHASE4
NCT07224776	RECRUITING	Proteinuric Renal Disease; Proteinuric Kidney Disease; Proteinuria; Proteinuria in Nephrotic Range	Brigham and Women's Hospital	2026-07-10	PHASE1
NCT05856760	COMPLETED	Immunoglobulin A Nephropathy	Travere Therapeutics, Inc.	2023-05-19	PHASE2
NCT05630612	ACTIVE_NOT_RECRUITING	ANCA Associated Vasculitis; Cardiovascular Diseases; Kidney Diseases	University of Edinburgh	2022-12-08	PHASE2
NCT05572229	Not yet recruiting	Multiple Myeloma	University Hospital Lille\|Janssen Pharmaceutica N.V. Belgium	2023-09	Phase 2
NCT03762850	ACTIVE_NOT_RECRUITING	Immunoglobulin A Nephropathy	Travere Therapeutics, Inc.	2018-12-11	PHASE3
NCT03493685	COMPLETED	Focal Segmental Glomerulosclerosis	Travere Therapeutics, Inc.	2018-04-17	PHASE3
NCT05408026	Withdrawn	Relapsed or Refractory Multiple Myeloma	Alliance Foundation Trials LLC.\|Janssen LP\|Celgene	2022-10-01	Phase 1\|Phase 2
NCT05004259	Active not recruiting	Hemolytic Anemia	Dartmouth-Hitchcock Medical Center	2022-03-21	Phase 1
NCT05562362	COMPLETED	Healthy Subjects	Travere Therapeutics, Inc.	2020-06-18	PHASE1
NCT01613118	COMPLETED	Focal Segmental Glomerulosclerosis	Travere Therapeutics, Inc.	2014-03	PHASE2
NCT00635232	COMPLETED	Hypertension	Ligand Pharmaceuticals	2008-03	PHASE2
NCT00522925	COMPLETED	Hypertension	Ligand Pharmaceuticals	2007-08	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-03)

Check the Sparsentan (PS-433540, RE-021) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sparsentan functions as a dual selective antagonist of endothelin type A receptors and angiotensin II type 1 receptors, suppressing downstream intracellular signaling cascades triggered by endothelin-1 and angiotensin II. This dual inhibition mitigates podocyte damage, decreases intraglomerular hemodynamics, and prevents renal fibrotic remodeling, which underlies its clinical efficacy in reducing proteinuria and preserving renal function in IgA nephropathy and focal segmental glomerulosclerosis.

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>).