Lesinurad sodium Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 290

Clinical Trials

Multiple clinical trials sponsored by Actelion evaluate clinical parameters and pharmacokinetics across Phase 1 through Phase 4 studies, primarily investigating pulmonary arterial hypertension, pulmonary hypertension, and safety profiles in healthy subjects. Encompassing completed, active but not recruiting, and terminated protocols, these studies address long-term follow-up safety, right ventricular remodeling, pediatric pharmacokinetics, and potential drug interaction dynamics.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04435782	Terminated	Pulmonary Arterial Hypertension	Actelion	2021-07-07	Phase 4
NCT04565990	Completed	Hypertension Pulmonary	Actelion	2021-05-03	Phase 3
NCT04175600	Active not recruiting	Hypertension Pulmonary	Actelion	2020-01-16	Phase 3
NCT03492177	Active not recruiting	Pulmonary Arterial Hypertension	Actelion	2018-07-23	Phase 2
NCT03496506	Completed	Healthy Subjects	Actelion	2018-03-05	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lesinurad sodium functions as a selective uric acid reabsorption inhibitor by binding to and inhibiting the urate transporter 1 (URAT1) as well as organic anion transporters OAT1 and OAT3. This transporter blockade prevents the renal reabsorption of uric acid, thereby promoting urinary urate excretion and reducing systemic serum uric acid levels to manage hyperuricemia in patients with gout.

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>).