Alisporivir Clinical Trials

Size	Price	Qty
1mg	USD 970
5mg	USD 3,209

Clinical Trials

Several clinical trials evaluate Alisporivir, focusing predominantly on chronic hepatitis C virus infection and pharmacokinetic evaluations in patients with chronic kidney failure and hepatic insufficiency. Sponsored by pharmaceutical entities including Debiopharm International SA and Enanta Pharmaceuticals Inc., these Phase 1 and Phase 2 studies have all completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02173574	Completed	Hepatitis C Virus	Enanta Pharmaceuticals Inc	2014-08	Phase 1
NCT01975337	Completed	Kidney Failure Chronic	Debiopharm International SA	2013-08	Phase 1
NCT01860326	Completed	Hepatic Insufficiency	Debiopharm International SA	2011-03	Phase 1
NCT00537407	Completed	Chronic Hepatitis C	Debiopharm International SA	2007-09	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alisporivir selectively binds to cyclophilin A, inhibiting its peptidyl-prolyl cis-trans isomerase activity and disrupting host-factor interactions required for viral replication complex formation. This blockade impairs host-mediated viral RNA synthesis and intracellular viral assembly, ultimately suppressing viral replication in therapeutic targets such as chronic hepatitis C infection.

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>).