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adapalene

Trade name: differin

Small moleculeapproved

Approved

May 31, 1996

Adapalene is a topical retinoid primarily used in the treatment of acne and is used (off-label) to treat keratosis pilaris as well as other skin conditions. Galderma currently markets it under the trade names Differin in some countries, and Adaferin in India. Adapalene acts on retinoid receptors. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. — NCATS

Clinical trial activity

101 trials · 110 clinical orgs · 19 marketing orgs

Phase 1
16
Phase 2
40
Phase 3
28
Phase 4
40

Earliest trial started Feb 1, 2004 (NCT00446043)

Timeline

1990s

  1. May 31, 1996

    Galderma — Earliest FDA Approval

  2. May 31, 1996

    Galderma — NDA Organization

2000s

  1. Jan 1, 2004

    Galderma — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Galderma — Earliest Phase 2 Sponsor(trial)

  2. Jun 2, 2010

    P&L Development — Marketing Organization

  3. Jun 2, 2010

    Pliva — Marketing Organization

  4. Jun 30, 2010

    Fougera — Marketing Organization

  5. Jun 14, 2012

    Tolmar Inc. — Marketing Organization

  6. Oct 27, 2014

    Actavis — Marketing Organization

  7. Jul 15, 2015

    Galderma — Marketing Organization

  8. Jul 15, 2015

    Nestle — NDA Secondary Org

  9. Sep 30, 2015

    Allergan PLC (2015) — Marketing Organization

  10. Jan 5, 2016

    Call Inc — Marketing Organization

  11. Apr 28, 2016

    Glenmark Pharmaceuticals — Marketing Organization

  12. Jun 23, 2016

    Taro Pharmaceuticals — Marketing Organization

  13. Jun 23, 2016

    Sun Pharmaceuticals — Marketing Organization

  14. Jan 23, 2018

    Padagis Us — Marketing Organization

  15. Jan 23, 2018

    Perrigo — Marketing Organization

  16. May 23, 2018

    Encube Ethicals Pvt. Ltd. — Marketing Organization

2020s

  1. Jun 18, 2020

    Alembic — Marketing Organization

  2. Jun 3, 2022

    Zydus Discovery DMCC — Marketing Organization

  3. Jun 22, 2022

    AbbVie — Marketing Organization

  4. Oct 20, 2023

    Bausch Health Companies — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedMay 31, 1996

Chemistry & pharmacology

Loading structure…

SMILES

COC1=C(C=C(C=C1)C2=CC=C3C=C(C=CC3=C2)C(O)=O)C45CC6CC(CC(C6)C4)C5
Mol. weight
412.5201 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 6-(3-(1-adamantyl)-4-methoxyphenyl)-2-naphthoic acid
  • 6-(3-(1-adamantyl)-4-methoxyphenyl)-2-naphthoic acid
  • adaferin
  • adaferin
  • adapalen
  • adapalen
  • adapalene
  • adapalene
  • adapalene
  • adapalene
  • adapalene
  • adapalene
  • adapalene
  • adapalene
  • adapalene
  • adapalene
  • adapalene
  • adapalene mixture with benzoyl peroxide
  • adapalene mixture with benzoyl peroxide
  • adapaleno
  • adapaleno
  • adapalenum
  • adapalenum
  • cd0271
  • cd-271
  • cd-271
  • differin
  • differin
  • differin
  • differin
  • differine
  • differine
  • gk530g

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07102186Phase 4Jul 21, 2025Badr University
NCT07016360Phase 4Jun 15, 2025Khyber Medical University Peshawer
NCT06775314Phase 3Mar 1, 2025University of Indonesia
NCT07015931Phase 1/Phase 2 (Phase 2)Nov 30, 2024University of Indonesia
NCT07237763N/AJan 15, 2024Cairo University
NCT06141330N/ADec 1, 2023HITEC-Institute of Medical Sciences
NCT05899699Phase 2Jun 5, 2023Mansoura University
NCT05536882Phase 3Feb 28, 2023University of Oklahoma
NCT05582434Early Phase 1 (Phase 1)Jan 31, 2023Bausch Health Companies, Wake Forest University
NCT05497323Phase 1Aug 1, 2022Rumah Sakit Mitra Masyarakat Hospital, University of Indonesia
NCT04823845Early Phase 1 (Phase 1)Dec 20, 2021University of Louisville
NCT04892706Phase 2Jun 11, 2021Bausch Health Companies
NCT04329403Phase 3May 31, 2020Aurobindo Pharma
NCT04797793Early Phase 1 (Phase 1)May 18, 2020Catawba Clinical Research, Taro Pharmaceuticals
NCT03866447Phase 4Oct 1, 2019Assiut University
NCT04104685Phase 2Sep 18, 2019Foamix Ltd.
NCT03832647Phase 4Feb 18, 2019Vichy Laboratoires
NCT03650881N/ADec 31, 2018New York University
NCT05096312Phase 4Dec 21, 2018East Avenue Medical Center, Philippines
NCT03650361Phase 3Oct 1, 2018Alembic, Catawba Clinical Research
Showing 20 of 101 trials
Page 1 / 6

Organizations

Research & Development (110)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GaldermaFor profit403842004
Bausch Health CompaniesFor profit6532008
Catawba Clinical ResearchFor profit6032012
GlaxoSmithKlineFor profit6112006
Stiefel LaboratoriesFor profit6622006
Taro PharmaceuticalsFor profit5522012
AllerganFor profit4432005
Wake Forest UniversityAcademic/Hospital4322006
ActavisFor profit3322009
Technical University of DresdenAcademic/Hospital3122006
University of IndonesiaAcademic/Hospital3332022
Chinese Academy of Medical SciencesAcademic/Hospital2022015
Henry Ford Health SystemAcademic/Hospital2022008
Johnson and JohnsonFor profit2012008
Lee's PharmaceuticalFor profit2222015
Minnesota Clinical Study CenterFor profit2022007
Pennsylvania State UniversityAcademic/Hospital2022008
PerrigoFor profit2212011
Academic Dermatology Associates - Albuquerque NMAcademic/Hospital1012007
Ache Laboratorios Farmaceuticos S.A.For profit1112015
110 organizations
Page 1 / 6

Marketing (28)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGJun 22, 2022
ActavisFor profitSYNJun 22, 2022
ActavisFor profitMKTGOct 27, 2014
AlembicFor profitMKTGJun 18, 2020
AlembicFor profitSYNJun 18, 2020
Allergan PLC (2015)For profitMKTGSep 30, 2015
Bausch Health CompaniesFor profitNDA2Oct 20, 2023
Call IncFor profitMKTGJan 5, 2016
Encube Ethicals Pvt. Ltd.For profitMKTGMay 23, 2018
Encube Ethicals Pvt. Ltd.For profitSYNJun 14, 2012
FougeraFor profitMKTGJun 30, 2010
GaldermaFor profitNDAMay 31, 1996
GaldermaFor profitMKTGJul 15, 2015
Glenmark PharmaceuticalsFor profitSYNJul 1, 2010
Glenmark PharmaceuticalsFor profitMKTGApr 28, 2016
Glenmark PharmaceuticalsFor profitSYNJul 1, 2010
NestleFor profitNDA2Jul 15, 2015
P&L DevelopmentFor profitMKTGJun 2, 2010
Padagis UsFor profitMKTGJan 23, 2018
PerrigoFor profitSYNNov 25, 2019
PerrigoFor profitSYNJan 23, 2018
PerrigoFor profitMKTGJan 23, 2018
PlivaFor profitMKTGJun 2, 2010
Sun PharmaceuticalsFor profitMKTGJun 23, 2016
Taro PharmaceuticalsFor profitSYNJan 14, 2022
Taro PharmaceuticalsFor profitMKTGJun 23, 2016
Tolmar Inc.For profitMKTGJun 14, 2012
Zydus Discovery DMCCFor profitMKTGJun 3, 2022