auranofin

Trade name: ridaura

Small moleculeapproved

Approved

May 24, 1985

Auranofin (brand name Ridaura) is an organogold compound classified by the World Health Organization as an antirheumatic agent. Ridaura is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. The mechanism of action of is not understood. In patients with adult rheumatoid arthritis, it may modify disease activity as manifested by synovitis and associated symptoms, and reflected by laboratory parameters such as ESR. There is no substantial evidence, however, that gold-containing compounds induce remission of rheumatoid arthritis. It may act as an inhibitor of kappab kinase and thioredoxin reductase, which would lead to a decreased immune response and decreased free radical production, respectively. In patients with inflammatory arthritis, such as adult and juvenile rheumatoid arthritis, gold salts can decrease the inflammation of the joint lining. This effect can prevent destruction of bone and cartilage. Ridaura should be added to a comprehensive baseline program, including non-drug therapies. Unlike anti-inflammatory drugs, RIDAURA does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months. — NCATS

Clinical trial activity

13 trials · 17 clinical orgs · 2 marketing orgs

Phase 1
5
Phase 2
6
Phase 3
0
Phase 4
0

Earliest trial started Sep 1, 2011 (NCT01419691)

Timeline

1980s

  1. May 24, 1985

    Sebela Pharmaceuticals — Earliest FDA Approval

  2. May 24, 1985

    LEGACY PHARMA — Marketing Organization

  3. May 24, 1985

    Sebela Pharmaceuticals — NDA Organization

  4. May 24, 1985

    Sebela Pharmaceuticals — NDA Secondary Org

2010s

  1. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

  • Unspecified targetOTHER

    Unknown

    Mode of action not fully understood; it seems to interact with IKKB, which may play a role in its anti-rheumatic effects

Approval history

  • approvedPriority reviewMay 24, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CC[P](CC)(CC)[Au+][S-][C@@H]1O[C@H](COC(C)=O)[C@@H](OC(C)=O)[C@H](OC(C)=O)[C@H]1OC(C)=O
Mol. weight
678.484 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • (1-thio-beta-d-glucopyranosato)(triethylphosphine)gold 2,3,4,6-tetraacetate
  • (1-thio-beta-d-glucopyranosato)(triethylphosphine)gold 2,3,4,6-tetraacetate
  • 2,3,4,6-tetra-o-acetyl-1-thio-beta-d-glucopyranosato-s (triethylphosphine)gold
  • 2,3,4,6-tetra-o-acetyl-1-thio-beta-d-glucopyranosato-s (triethylphosphine)gold
  • auranofin
  • auranofin
  • auranofin
  • auranofin
  • auranofin
  • auranofin
  • auranofin
  • auranofin
  • auranofin
  • auranofin
  • auranofina
  • auranofina
  • auranofine
  • auranofine
  • auranofinum
  • auranofinum
  • ridaura
  • ridaura
  • ridaura
  • ridaura
  • sk-39162
  • sk-39162
  • sk&f-39162
  • sk&f-39162
  • triethylphosphine gold
  • triethylphosphine gold

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06805656N/AApr 1, 2025Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Sao Paulo
NCT03456700Phase 2Mar 30, 2018Mayo Clinic, National Cancer Institute (NCI)
NCT02968927Phase 2Nov 1, 2016Aurum Institute
NCT02770378Phase 1Nov 1, 2016Government of Belgium, Reliable Cancer Therapies, University of Ulm
NCT02736968Phase 2Aug 19, 2016National Institute of Allergy and Infectious Diseases (NIAID)
NCT02961829N/AJul 1, 2015Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo, ViiV Healthcare
NCT02176135Phase 1/Phase 2 (Phase 2)Jun 24, 2014University of Miami, Vaccine and Gene Therapy Institute, Florida
NCT02089048Phase 1Apr 2, 2014National Institute of Allergy and Infectious Diseases (NIAID)
NCT02063698N/AFeb 1, 2014Mayo Clinic, National Cancer Institute (NCI)
NCT02126527Phase 1Aug 1, 2013Mayo Clinic, National Cancer Institute (NCI)
NCT01747798N/ANov 1, 2012Mayo Clinic
NCT01737502Phase 1/Phase 2 (Phase 2)Nov 1, 2012Mayo Clinic, National Cancer Institute (NCI)
NCT01419691Phase 2Sep 1, 2011Kansas Bioscience Authority, The Leukemia and Lymphoma Society, University of Kansas
Showing 13 of 13 trials
Page 1 / 1

Organizations

Research & Development (17)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mayo ClinicAcademic/Hospital5532012
National Cancer Institute (NCI)Government4032012
Conselho Nacional de Desenvolvimento Científico e TecnológicoGovernment2012015
National Institute of Allergy and Infectious Diseases (NIAID)Government2222014
Aurum InstituteAcademic/Hospital1112016
Federal University of Sao PauloAcademic/Hospital1112025
Fundação de Amparo à Pesquisa do Estado de São PauloAcademic/Hospital1012015
Government of BelgiumGovernment1012016
Kansas Bioscience AuthorityAcademic/Hospital1012011
Reliable Cancer TherapiesAcademic/Hospital1012016
The Leukemia and Lymphoma SocietyAcademic/Hospital1012011
University of KansasAcademic/Hospital1112011
University of MiamiAcademic/Hospital1012014
University of Sao PauloAcademic/Hospital1112015
University of UlmAcademic/Hospital1112016
Vaccine and Gene Therapy Institute, FloridaAcademic/Hospital1112014
ViiV HealthcareFor profit1012015
17 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
LEGACY PHARMAFor profitMKTGMay 24, 1985
Sebela PharmaceuticalsFor profitNDAMay 24, 1985
Sebela PharmaceuticalsFor profitNDA2May 24, 1985