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acitretin

Trade name: soriatane

Small moleculeapproved

Approved

Oct 28, 1996

Acitretin is all-Trans-9-(4-methoxy-2, 3, 6¬ trimethylphenyl)-three, 7-dimethyl-2, 4, 6, 8-nonatetraenoic acid. It is a metabolite of exterminate and is related to both retinoic acid and retinol (vitamin A). It is taken orally, and is typically used for psoriasis. The mechanism of action of is unknown. However it is believed to work by targeting specific receptors (retinoid receptors such as RXR and RAR) in the skin, which help normalize the growth cycle of skin cells. Studies on nuclear retinoic acid receptors have shown that acitretin activates all 3 receptor subtypes (RAR-alpha, -beta, and -gamma) without measurable receptor binding; this paradox remains unexplained. — NCATS

Clinical trial activity

29 trials · 38 clinical orgs · 7 marketing orgs

Phase 1
1
Phase 2
6
Phase 3
2
Phase 4
16

Earliest trial started Nov 2, 1999 (NCT00002143)

Timeline

1990s

  1. Oct 28, 1996

    Stiefel Laboratories — Earliest FDA Approval

  2. Oct 28, 1996

    Stiefel Laboratories — NDA Organization

  3. Oct 28, 1996

    Stiefel Laboratories — NDA Secondary Org

  4. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Apr 4, 2013

    Barr Laboratories — Marketing Organization

  2. Apr 4, 2013

    Teva — Marketing Organization

  3. May 22, 2015

    Sigmapharm Laboratories — Marketing Organization

  4. Sep 10, 2015

    Mylan — Marketing Organization

  5. Dec 23, 2015

    Impax Laboratories — Marketing Organization

  6. Jan 1, 2019

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Aug 5, 2024

    Alembic — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedOct 28, 1996

Chemistry & pharmacology

Loading structure…

SMILES

COC1=CC(C)=C(\C=C\C(C)=C\C=C\C(C)=C\C(O)=O)C(C)=C1C
Mol. weight
326.4293 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • acetretin
  • acetretin
  • acitretin
  • acitretin
  • acitretin
  • acitretin
  • acitretin
  • acitretin
  • acitretin
  • acitretin
  • acitretin
  • acitretin
  • acitretin
  • acitretin
  • acitretina
  • acitretina
  • acitretine
  • acitretine
  • acitretinoin
  • acitretinum
  • acitretinum
  • actiretin
  • (all-e)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid
  • (all-e)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid
  • all-trans-3,7-dimethyl-9-(4-methoxy-2,3,6-trimethylphenyl)-2,4,6,8-nonatetraenoic acid
  • all-trans-3,7-dimethyl-9-(4-methoxy-2,3,6-trimethylphenyl)-2,4,6,8-nonatetraenoic acid
  • etretin
  • etretin
  • etretin
  • etretin
  • isoacitretin
  • isoetretin
  • neotigason
  • neotigason
  • neotigason
  • neotigason
  • neotigason
  • ro-101670000
  • ro-101670000
  • soriatane
  • soriatane
  • soriatane
  • soriatane

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06998875Phase 4Mar 1, 2025People's Liberation Army of China
NCT06739551Phase 2Dec 10, 2024Sheikh Zayed Medical College
NCT05184348Phase 4Nov 23, 2021South Valley University
NCT05401006Phase 4Jun 5, 2021South Valley University
NCT04537689Phase 4Nov 16, 2020Singapore General Hospital, SingHealth Investigational Medicine Unit
NCT04239859Phase 4Feb 29, 2020Singapore General Hospital, SingHealth Investigational Medicine Unit
NCT04245319N/AJan 1, 2020Cairo University
NCT03753867Phase 1Jan 7, 2019University of Ottawa
NCT05203354Phase 4Sep 1, 2018Aswan University
NCT02715960Phase 2Dec 1, 2015Central South University
NCT02181790Phase 4Jun 1, 2014Icahn School of Medicine at Mount Sinai
NCT02050321Phase 2Dec 1, 2013University of Arizona
NCT02191020N/AFeb 1, 2013Dalian Medical University, Henan Medical University, People's Liberation Army of China
NCT01545284Phase 2/Phase 3 (Phase 3)Mar 1, 2012Innovaderm, Tribute Pharmaceuticals, Windsor Clinical Research
NCT01443338Phase 4Sep 1, 2011Government of China, Zhejiang University
NCT01299220Phase 4Nov 1, 2010OSI Pharmaceuticals, University of Pittsburgh
NCT01228409Phase 4Oct 1, 2010Frankel, Amylynne, M.D., GlaxoSmithKline
NCT01078168Phase 2Mar 1, 2010Alzheimer Forschungsinitiative e.V., Johannes Gutenburg University
NCT01094717N/AJan 31, 2010University of Utah
NCT00832364Phase 4Oct 1, 2009GlaxoSmithKline, Stiefel Laboratories
Showing 20 of 29 trials
Page 1 / 2

Organizations

Research & Development (38)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit2012009
Mayo ClinicAcademic/Hospital2112000
National Cancer Institute (NCI)Government2112000
People's Liberation Army of ChinaGovernment2222013
Singapore General HospitalAcademic/Hospital2212020
SingHealth Investigational Medicine UnitFor profit2012020
South Valley UniversityAcademic/Hospital2212021
Alzheimer Forschungsinitiative e.V.Academic/Hospital1012010
Aswan UniversityAcademic/Hospital1112018
Cairo UniversityAcademic/Hospital1112020
Central South UniversityAcademic/Hospital1112015
ConneticsFor profit1012005
Dalian Medical UniversityAcademic/Hospital1012013
Frankel, Amylynne, M.D.Academic/Hospital1112010
Government of ChinaGovernment1112011
Henan Medical UniversityAcademic/Hospital1012013
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112014
InnovadermFor profit1112012
Istituti Fisioterapici OspitalieriAcademic/Hospital1112005
Johannes Gutenburg UniversityAcademic/Hospital1112010
38 organizations
Page 1 / 2

Marketing (9)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGAug 5, 2024
Barr LaboratoriesFor profitMKTGApr 4, 2013
Impax LaboratoriesFor profitMKTGDec 23, 2015
MylanFor profitMKTGSep 10, 2015
MylanFor profitSYNSep 10, 2015
Sigmapharm LaboratoriesFor profitMKTGMay 22, 2015
Stiefel LaboratoriesFor profitNDAOct 28, 1996
Stiefel LaboratoriesFor profitNDA2Oct 28, 1996
TevaFor profitMKTGApr 4, 2013