Clinical Trials

Voclosporin has been evaluated in multiple clinical trials spanning Phase 1 through Phase 4 for various autoimmune, ocular, and nephrological disorders, primarily lupus nephritis, systemic lupus erythematosus, dry eye syndrome, plaque psoriasis, focal segmental glomerulosclerosis, and kidney transplantation. Sponsored by industry entities including Aurinia Pharmaceuticals Inc. and Qilu Pharmaceutical Co., Ltd., as well as institutional sponsors like the National Institute of Allergy and Infectious Diseases, these studies exhibit recruitment statuses ranging from completed and actively recruiting to terminated and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07760480 RECRUITING
Lupus Nephritis; Systemic Lupus Erythematosus (SLE)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2026-04-23 PHASE4
NCT06406205 RECRUITING
Lupus Nephritis
Qilu Pharmaceutical Co., Ltd.
 2023-12-25 PHASE3
NCT07225387 RECRUITING
Lupus Nephritis
NephroNet, Inc.
 2024-10-01 PHASE4
NCT05962788 TERMINATED
Adolescent Lupus Nephritis; Pediatric Lupus Nephritis
Aurinia Pharmaceuticals Inc.
 2024-03-28 PHASE3
NCT05288855 TERMINATED
Adolescent Lupus Nephritis; Pediatric Lupus Nephritis
Aurinia Pharmaceuticals Inc.
 2023-10-10 PHASE3
NCT05306873 TERMINATED
Systemic Lupus Erythematosus
National Institute of Allergy and Infectious Diseases (NIAID)
 2022-11-30 PHASE2
NCT05306379 COMPLETED
Drug-drug Interaction
Aurinia Pharmaceuticals Inc.
 2022-01-24 PHASE1
NCT04701528 COMPLETED
Covid19; Kidney Transplant Infection
Leiden University Medical Center
 2020-11-15 PHASE2
NCT03597464 COMPLETED
Lupus Nephritis
Aurinia Pharmaceuticals Inc.
 2019-09-29 PHASE3
NCT04147650 COMPLETED
Dry Eye Syndrome; Keratoconjunctivitis Sicca
Aurinia Pharmaceuticals Inc.
 2019-10-14 PHASE2; PHASE3
NCT03598036 TERMINATED
Focal Segmental Glomerulosclerosis
Aurinia Pharmaceuticals Inc.
 2018-06-21 PHASE2
NCT03021499 COMPLETED
Lupus Nephritis
Aurinia Pharmaceuticals Inc.
 2017-05-17 PHASE3
NCT03597139 COMPLETED
Dry Eye
Aurinia Pharmaceuticals Inc.
 2018-08-13 PHASE2
NCT02949973 COMPLETED
Lupus Nephritis
Aurinia Pharmaceuticals Inc.
 2015-06 PHASE2
NCT02949999 COMPLETED
Volunteers
Aurinia Pharmaceuticals Inc.
 2016-10 PHASE1
NCT02141672 COMPLETED
Lupus Nephritis
Aurinia Pharmaceuticals Inc.
 2014-06 PHASE2
NCT01586845 WITHDRAWN
Renal Transplantation
Aurinia Pharmaceuticals Inc.
 2013-03 PHASE3
NCT01243983 COMPLETED
Noninfectious Uveitis
Lux Biosciences, Inc.
 2011-02 PHASE3
NCT00270634 COMPLETED
Kidney Diseases
Aurinia Pharmaceuticals Inc.
 2006-01 PHASE2
NCT00851734 COMPLETED
Keratoconjunctivitis Sicca
Lux Biosciences, Inc.
 2009-02 PHASE1
NCT00408187 COMPLETED
Psoriasis
Aurinia Pharmaceuticals Inc.
 2006-12 PHASE3
NCT00258713 COMPLETED
Psoriasis
Aurinia Pharmaceuticals Inc.
 2005-09 PHASE3
NCT00244842 COMPLETED
Psoriasis
Aurinia Pharmaceuticals Inc.
 2004-12 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Voclosporin binds to calcineurin and inhibits its phosphatase activity, which blocks downstream dephosphorylation of nuclear factor of activated T-cells and stops T-cell proliferation and cytokine secretion. By stabilizing the podocyte cytoskeleton and suppressing T-lymphocyte activation, this mechanism reduces proteinuria and immune-mediated renal damage in clinical conditions such as lupus nephritis and systemic lupus erythematosus.

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>).

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Note: Technical data last updated: Sep 1, 2026.