tazarotene

Trade name: tazorac

Small moleculeapproved

Approved

Jun 13, 1997

Tazarotene is a prodrug and a member of the acetylenic class of retinoids. Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. When treating acne tazarotene may be taken in conjunction with an oral antibiotic. Tazarotene has been shown in peer-reviewed double blinded studies to reduce: mottling and hyperpigmentation, sallowness, fine wrinkling and coarse wrinkling in sun damaged skin. Histological studies have shown that long term (greater than 1 year) use of Tazarotene is associated with a significant reduction in atypical melanocytes and keratocytes - cells considered to be precursors of skin cancer. Some studies have shown long term use of Tazarotene to be associated with increased collagen production and better organization of skin collagen bundles. Although the exact mechanism of tazarotene action is not known, studies have shown that the active form of the drug (tazarotenic acid) binds to all three members of the retinoic acid receptor (RAR) family: RARa, RARb, and RARg, but shows relative selectivity for RARb, and RARg and may modify gene expression. It also has affinity for RXR receptors. Tazarotene is used to treat psoriasis, acne and sun damaged skin (photodamage). Tazarotene is marketed as Tazorac, Avage, Zorac, and Fabior. — NCATS

Clinical trial activity

60 trials · 47 clinical orgs · 16 marketing orgs

Phase 1
10
Phase 2
27
Phase 3
14
Phase 4
17

Earliest trial started Mar 1, 2002 (NCT00145106)

Timeline

1990s

  1. Jun 13, 1997

    Allergan — Earliest FDA Approval

  2. Jun 13, 1997

    Allergan — NDA Organization

  3. Jun 13, 1997

    Allergan — NDA Secondary Org

  4. Jun 13, 1997

    SmithKline Beecham — NDA Secondary Org

2000s

  1. Sep 29, 2000

    GlaxoSmithKline — NDA Secondary Org

  2. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

2010s

  1. May 11, 2012

    Mayne Pharma — NDA Secondary Org

  2. Apr 3, 2017

    Taro Pharmaceuticals — Marketing Organization

  3. Apr 3, 2017

    Sun Pharmaceuticals — Marketing Organization

  4. Dec 22, 2017

    Cosette — Marketing Organization

  5. Dec 22, 2017

    G & W Laboratories Inc. — Marketing Organization

  6. Dec 22, 2017

    ACP Nimble — Marketing Organization

  7. Jan 28, 2019

    Fougera — Marketing Organization

  8. Jan 28, 2019

    Novartis — Marketing Organization

  9. Apr 25, 2019

    Bausch Health Companies — Marketing Organization

  10. Apr 25, 2019

    Bausch Health Companies — NDA Secondary Org

  11. Dec 18, 2019

    Dow Pharmaceutical Sciences — Marketing Organization

2020s

  1. Mar 20, 2023

    Solaris Pharma Corp — Marketing Organization

  2. Mar 20, 2023

    Donaldson Company — Marketing Organization

  3. Apr 25, 2023

    Padagis Us — Marketing Organization

Indications

Mechanism of action

Combination products

Approval history

  • approvedJun 13, 1997

Chemistry & pharmacology

Loading structure…

SMILES

CCOC(=O)C1=CN=C(C=C1)C#CC2=CC=C3SCCC(C)(C)C3=C2
Mol. weight
351.462 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Prodrug

Sources

Also known as

  • 3-pyridinecarboxylic acid, 6-((3,4-dihydro-4,4-dimethyl-2h-1-benzothiopyran-6-yl)ethynyl)-, ethyl ester
  • agn 190168
  • agn-190168
  • agn-190168
  • agn-190168
  • agn-190168
  • agn-190168
  • avage
  • avage
  • ethyl 6-(2-(4,4-dimethylthiochroman-6-yl)ethynyl)nicotinate
  • fabior
  • fabior
  • fabior
  • idp-123
  • tazaroc
  • tazarotene
  • tazarotene
  • tazarotene
  • tazarotene
  • tazarotene
  • tazarotene
  • tazarotene
  • tazarotene
  • tazarotene
  • tazarotene
  • tazarotene
  • tazaroteno
  • tazaroteno
  • tazarotenum
  • tazarotenum
  • tazorac
  • tazorac
  • tazorac
  • tazorac
  • tazorac
  • tazorac
  • zorac
  • zorac

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06042647Phase 4Jul 13, 2023Dermatology Consulting Services, High Point NC
NCT05872256Phase 4Jun 1, 2023Dermatology Consulting Services, High Point NC
NCT05555797Phase 4Oct 30, 2022Assiut University
NCT05608499Phase 3Oct 4, 2022Bausch Health Companies, Icahn School of Medicine at Mount Sinai
NCT06015152N/AAug 1, 2022Jinnah Postgraduate Medical Centre, University of Karachi
NCT05314127Phase 2Apr 15, 2022Zagazig University
NCT05203315Phase 3Jan 17, 2022Austin Institute for Clinical Research
NCT05282771Early Phase 1 (Phase 1)Apr 16, 2021Catawba Clinical Research, Taro Pharmaceuticals
NCT05704114Phase 4Feb 1, 2021The Dermatology Institute of Boston
NCT04720105Phase 4Nov 19, 2020Bausch Health Companies, Icahn School of Medicine at Mount Sinai
NCT05573425Phase 2/Phase 3 (Phase 3)Aug 22, 2020Jinnah Postgraduate Medical Centre
NCT04119102Phase 4Oct 1, 2019Bausch Health Companies, Windsor Dermatology
NCT04071756Phase 2Sep 30, 2019Bayer, Harvard University
NCT03988439Phase 4Jun 8, 2019Bausch Health Companies
NCT03599193Phase 2Oct 17, 2017Dr. Reddy's Laboratories
NCT03263624Phase 4Oct 1, 2017Assiut University
NCT03341910Phase 2Aug 21, 2017Dr. Reddy's Laboratories
NCT03290027Phase 3Jul 31, 2017Dr. Reddy's Laboratories
NCT03168334Phase 3Jul 11, 2017Bausch Health Companies
NCT03292640Phase 3Jul 6, 2017Dr. Reddy's Laboratories
Showing 20 of 60 trials
Page 1 / 3

Organizations

Research & Development (47)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bausch Health CompaniesFor profit10742015
GlaxoSmithKlineFor profit9042008
Stiefel LaboratoriesFor profit9942008
AllerganFor profit5322002
Dr. Reddy's LaboratoriesFor profit4422017
Icahn School of Medicine at Mount SinaiAcademic/Hospital3322011
Altman Dermatology AssociatesAcademic/Hospital2012014
Assiut UniversityAcademic/Hospital2212017
BayerFor profit2012008
Catawba Clinical ResearchFor profit2012014
Dermatology Consulting Services, High Point NCAcademic/Hospital2212023
FougeraFor profit2212016
GaldermaFor profit2222006
G & W Laboratories Inc.For profit2212014
Herbert Irving Comprehensive Cancer CenterAcademic/Hospital2012004
Jinnah Postgraduate Medical CentreAcademic/Hospital2222020
National Cancer Institute (NCI)Government2012004
Taro PharmaceuticalsFor profit2212014
University of California, San FranciscoAcademic/Hospital2212004
University of UtahAcademic/Hospital2212005
47 organizations
Page 1 / 3

Marketing (19)

OrganizationOrg typeRelationshipDate
ACP NimbleFor profitMKTGDec 22, 2017
AllerganFor profitNDAJun 13, 1997
AllerganFor profitNDA2Jun 13, 1997
Bausch Health CompaniesFor profitMKTGApr 25, 2019
Bausch Health CompaniesFor profitNDA2Apr 25, 2019
CosetteFor profitMKTGDec 22, 2017
Donaldson CompanyFor profitMKTGMar 20, 2023
Dow Pharmaceutical SciencesFor profitMKTGDec 18, 2019
FougeraFor profitMKTGJan 28, 2019
G & W Laboratories Inc.For profitMKTGDec 22, 2017
GlaxoSmithKlineFor profitNDA2Sep 29, 2000
Mayne PharmaFor profitNDA2May 11, 2012
NovartisFor profitMKTGJan 28, 2019
Padagis UsFor profitMKTGApr 25, 2023
SmithKline BeechamFor profitNDA2Jun 13, 1997
Solaris Pharma CorpFor profitMKTGMar 20, 2023
Sun PharmaceuticalsFor profitMKTGApr 3, 2017
Taro PharmaceuticalsFor profitMKTGApr 3, 2017
Taro PharmaceuticalsFor profitSYNApr 3, 2017