Clinical Trials

Multiple clinical trials evaluate auranofin across Early Phase 1 through Phase 2 stages, focusing on infectious diseases such as amoebiasis, giardiasis, and HIV, as well as oncological conditions including recurrent ovarian cancer, chronic lymphocytic leukemia, and non-small cell lung carcinoma. Sponsored primarily by academic medical centers and public research institutes, such as the National Institute of Allergy and Infectious Diseases and Mayo Clinic, these studies display recruitment statuses ranging from recruiting and completed to terminated, unknown, and withdrawn. Together, these investigations reflect ongoing efforts toward the clinical repurposing of the drug.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06805656 RECRUITING
Hiv; HIV I Infection
Federal University of São Paulo
 2026-07-15 PHASE2
NCT01737502 COMPLETED
Extensive Stage Small Cell Lung Carcinoma; Lung Adenocarcinoma; Recurrent Non-Small Cell Lung Carcinoma; Recurrent Small Cell Lung Carcinoma; Squamous Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer
Mayo Clinic
 2014-05-14 PHASE1; PHASE2
NCT02736968 COMPLETED
Amoebic Dysentery; Giardiasis
National Institute of Allergy and Infectious Diseases (NIAID)
 2016-11-06 PHASE2
NCT03456700 TERMINATED
Ovarian Serous Tumor; Recurrent Ovarian Carcinoma
Mayo Clinic
 2018-03-30 PHASE2
NCT02961829 COMPLETED
Chronic Infection; HIV
Federal University of São Paulo
 2015-07
NCT02770378 COMPLETED
Glioblastoma
University of Ulm
 2016-11 PHASE1; PHASE2
NCT02968927 UNKNOWN
Tuberculosis
The Aurum Institute NPC
 2016-11 PHASE2
NCT02176135 WITHDRAWN
HIV
Vaccine and Gene Therapy Institute, Florida
 PHASE1; PHASE2
NCT02063698 COMPLETED
Pain
Mayo Clinic
 2014-02-19 PHASE2
NCT01419691 COMPLETED
Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma; Leukemia, Prolymphocytic
University of Kansas Medical Center
 2011-09 PHASE2
NCT02089048 COMPLETED
Amoebiasis
National Institute of Allergy and Infectious Diseases (NIAID)
 2014-04-02 PHASE1
NCT02126527 WITHDRAWN
Recurrent Non-small Cell Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Mayo Clinic
 2013-08 PHASE1
NCT02089048 Completed
Amoebiasis
National Institute of Allergy and Infectious Diseases (NIAID)
 2014-04-02 Phase 1
NCT01747798 COMPLETED
Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer
Mayo Clinic
 2012-11-02 EARLY_PHASE1
NCT01747798 Completed
Recurrent Fallopian Tube Cancer|Recurrent Ovarian Epithelial Cancer|Recurrent Primary Peritoneal Cavity Cancer
Mayo Clinic
 2012-11-02 Early Phase 1
NCT01419691 Completed
Chronic Lymphocytic Leukemia (CLL)|Small Lymphocytic Lymphoma|Leukemia Prolymphocytic
University of Kansas Medical Center|The Leukemia and Lymphoma Society|Kansas Bioscience Authority|Therapeutics for Rare and Neglected Diseases (TRND)
 2011-09 Phase 2
NCT02176135 Withdrawn
HIV
Vaccine and Gene Therapy Institute Florida|University of Miami
 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-19)

Check the Auranofin (SKF-39162) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Auranofin binds to and inhibits thioredoxin reductase, disrupting cellular redox homeostasis and causing an accumulation of reactive oxygen species that triggers apoptotic cell death. This targeted disruption of antioxidant defense mechanisms impairs tumor cell survival, providing a mechanistic foundation for its evaluation in clinical trials for non-small cell lung cancer, chronic lymphocytic leukemia, and recurrent ovarian carcinoma.

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.