Lixivaptan (VPA-985) Clinical Trials

Size	Price	Qty
5mg	USD 357

Clinical Trials

Multiple clinical trials across Phase 2 and Phase 3 have evaluated lixivaptan for autosomal dominant polycystic kidney disease, congestive heart failure, and chronic hyponatremia under industry sponsorship from Palladio Biosciences, Centessa Pharmaceuticals, CardioKine, and Biogen. Although earlier Phase 2 studies and hyponatremia protocols successfully completed recruitment, key late-stage Phase 3 trials in kidney disease were ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05208866	Terminated	Polycystic Kidney Disease Adult	Palladio Biosciences\|Centessa Pharmaceuticals plc	2022-02-10	Phase 3
NCT04064346	Terminated	Autosomal Dominant Polycystic Kidney\|ADPKD	Palladio Biosciences\|Centessa Pharmaceuticals plc	2021-10-28	Phase 3
NCT04152837	Terminated	Polycystic Kidney Disease Adult\|ADPKD	Palladio Biosciences\|Centessa Pharmaceuticals plc	2020-09-02	Phase 3
NCT03487913	Completed	Autosomal Dominant Polycystic Kidney Disease	Palladio Biosciences	2018-09-14	Phase 2
NCT01055912	Completed	Congestive Heart Failure	CardioKine Inc.\|Cardiokine Biopharma LLC	2010-01	Phase 2
NCT01056848	Completed	Hyponatremia With Normal Extracellular Fluid Volume\|Hyponatremia With Excess Extracellular Fluid Volume	CardioKine Inc.\|Cardiokine Biopharma LLC\|Biogen	2010-01	--

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

Check the Lixivaptan (VPA-985) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lixivaptan selectively binds to human vasopressin V2 receptors in the renal collecting duct, blocking arginine vasopressin binding and suppressing downstream intracellular cyclic AMP accumulation. This inhibition decreases water channel insertion into the apical membrane to promote aquaresis, reducing fluid retention and cystogenesis in clinical indications such as autosomal dominant polycystic kidney disease, congestive heart failure, and hyponatremia.

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>).