CDEK
← All drugs Report issue

voclosporin

Trade name: Lupkynis

Small moleculeapprovedFast Track FDA

Approved

Jan 22, 2021

Voclosporin, sold under the brand name Lupkynis, is a calcineurin inhibitor used as an immunosuppressant medication for the treatment of lupus nephritis. It is an analog of ciclosporin that has enhanced action against calcineurin and greater metabolic stability. — Wikipedia

Clinical trial activity

26 trials · 23 clinical orgs · 1 marketing orgs

Phase 1
3
Phase 2
20
Phase 3
14
Phase 4
1

Earliest trial started Dec 1, 2004 (NCT00244842)

Timeline

2000s

  1. Jan 1, 2004

    Aurinia Pharmaceuticals Inc. — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Aurinia Pharmaceuticals Inc. — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Jan 22, 2021

    Aurinia Pharmaceuticals Inc. — Earliest FDA Approval

  2. Jan 22, 2021

    Aurinia Pharmaceuticals Inc. — Marketing Organization

  3. Jan 22, 2021

    Aurinia Pharmaceuticals Inc. — NDA Secondary Org

  4. Jan 22, 2021

    Aurinia Pharmaceuticals Inc. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackJan 22, 2021

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C=C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C
Mol. weight
1214.65 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • isa247
  • isa247
  • isa247
  • isa 247
  • isa 247
  • isa-247
  • isa-247
  • isatx247
  • isatx247
  • isatx247
  • isatx247
  • isatx247
  • isatx247
  • isa(tx)247
  • lx211
  • lx211
  • voclosporin
  • voclosporin
  • voclosporin
  • voclosporin
  • voclosporin
  • voclosporin
  • voclosporin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07225387Phase 4Oct 1, 2024NephroNet Clinical Research Consortium
NCT05962788Phase 3Dec 31, 2023Aurinia Pharmaceuticals Inc., LabCorp
NCT06406205Phase 3Dec 25, 2023Qilu Pharmaceutical Co., Ltd.
NCT05306873Phase 2Oct 28, 2022National Institute of Allergy and Infectious Diseases (NIAID)
NCT05288855Phase 3Aug 31, 2022Aurinia Pharmaceuticals Inc.
NCT05306379Phase 1Jan 24, 2022Aurinia Pharmaceuticals Inc.
NCT04701528Phase 2Nov 15, 2020Aurinia Pharmaceuticals Inc., Leiden University
NCT04147650Phase 2/Phase 3 (Phase 3)Oct 14, 2019Aurinia Pharmaceuticals Inc.
NCT03597139Phase 2Aug 17, 2018Aurinia Pharmaceuticals Inc.
NCT03598036Phase 2Jun 21, 2018Aurinia Pharmaceuticals Inc.
NCT03597464Phase 3Jun 12, 2018Aurinia Pharmaceuticals Inc.
NCT03021499Phase 3May 17, 2017Aurinia Pharmaceuticals Inc., University of North Carolina at Chapel Hill
NCT02949999Phase 1Oct 1, 2016Aurinia Pharmaceuticals Inc.
NCT02949973Phase 2Jun 1, 2015Aurinia Pharmaceuticals Inc.
NCT02141672Phase 2Jun 1, 2014Aurinia Pharmaceuticals Inc., University of North Carolina at Chapel Hill
NCT01586845Phase 3Mar 1, 2013Aurinia Pharmaceuticals Inc.
NCT01243983Phase 3Feb 1, 2011Lux Biosciences, Inc.
NCT01236287N/ANov 4, 2010Cornell University
NCT00851734Phase 1Feb 1, 2009Lux Biosciences, Inc.
NCT00404612Phase 3Jan 1, 2007Lux Biosciences, Inc.
Showing 20 of 26 trials
Page 1 / 2

Organizations

Research & Development (23)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Aurinia Pharmaceuticals Inc.For profit171632004
Lux Biosciences, Inc.For profit5522007
Eastern Canada Cutaneous Research Associates Ltd.Academic/Hospital2012004
InnovadermFor profit2012004
Probity Medical ResearchFor profit2012004
University of North Carolina at Chapel HillAcademic/Hospital2022014
Ventana Clinical Research CorporationFor profit2012004
Cornell UniversityAcademic/Hospital1112010
Erasmus University RotterdamAcademic/Hospital1012006
Humboldt UniversityAcademic/Hospital1012006
Indiana UniversityAcademic/Hospital1012006
LabCorpFor profit1012023
Leiden UniversityAcademic/Hospital1112020
Methodist Cancer Center, Houston, TexasAcademic/Hospital1012006
National Institute of Allergy and Infectious Diseases (NIAID)Government1112022
NephroNet Clinical Research ConsortiumAcademic/Hospital1112024
NewLab Clinical ResearchAcademic/Hospital1012006
Przychodnia DermatologicznaAcademic/Hospital1012006
Qilu Pharmaceutical Co., Ltd.For profit1112023
University of AlbertaAcademic/Hospital1012005
23 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
Aurinia Pharmaceuticals Inc.For profitMKTGJan 22, 2021
Aurinia Pharmaceuticals Inc.For profitNDA2Jan 22, 2021
Aurinia Pharmaceuticals Inc.For profitNDAJan 22, 2021