CDEK
← All drugs Report issue

tretinoin

Trade name: Retin-A

Small moleculeapproved

Approved

Oct 20, 1971

All-trans retinoic acid (ATRA) also known as tretinoin is an active metabolite of vitamin A that has been demonstrated to inhibit the growth of cancer cells, some types of epithelial cells, and vascular smooth muscles. It is medication used for the treatment of acne. Tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline based chemotherapy is contraindicated. Tretinoin is for the induction of remission only. For acne it is applied to the skin as a cream or ointment. For leukemia it is taken by mouth for up to three months. The exact mechanism of action of tretinoin in APL and acne treatment is unknown, but is known, that tretinoin activates three members of the retinoid acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation. It has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors, other mechanisms, or both. — NCATS

Clinical trial activity

206 trials · 219 clinical orgs · 27 marketing orgs

Phase 1
49
Phase 2
120
Phase 3
48
Phase 4
32

Earliest trial started Oct 1, 1991 (NCT00002479)

Timeline

1970s

  1. Oct 20, 1971

    Earliest FDA Approval

  2. Oct 20, 1971

    Bausch Health Companies — NDA Secondary Org

1990s

  1. Jan 1, 1991

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1993

    Earliest Phase 3 Sponsor(trial)

  3. Nov 22, 1995

    CheplaPharm — NDA Secondary Org

  4. Jan 29, 1998

    Mylan — NDA Secondary Org

  5. Jun 19, 1998

    Teva — Marketing Organization

  6. Dec 24, 1998

    Perrigo — Marketing Organization

  7. Dec 24, 1998

    Padagis Us — Marketing Organization

  8. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

  9. Jan 25, 1999

    Wockhardt — Marketing Organization

  10. Dec 10, 1999

    Almirall — Marketing Organization

  11. Dec 10, 1999

    Almirall — NDA Secondary Org

2000s

  1. Jan 18, 2002

    Galderma — Marketing Organization

  2. Sep 15, 2005

    Zo Skin Health — Marketing Organization

  3. Nov 7, 2006

    Medicis — Marketing Organization

  4. Jun 21, 2007

    Barr Laboratories — Marketing Organization

  5. Jul 26, 2007

    Dow Pharmaceutical Sciences — NDA Secondary Org

2010s

  1. Mar 22, 2010

    Allergan — Marketing Organization

  2. Mar 22, 2010

    GlaxoSmithKline — Marketing Organization

  3. Oct 24, 2012

    Anchen Pharmaceuticals, Inc — Marketing Organization

  4. Oct 24, 2012

    Par Pharmaceuticals — Marketing Organization

  5. Jul 17, 2013

    Mylan — Marketing Organization

  6. Jun 12, 2015

    Actavis — Marketing Organization

  7. Jun 12, 2015

    Allergan PLC (2015) — Marketing Organization

  8. Dec 23, 2016

    Glenmark Pharmaceuticals — Marketing Organization

  9. Jan 22, 2019

    Taro Pharmaceuticals — Marketing Organization

  10. Jan 22, 2019

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. Jul 26, 2021

    Sol-Gel Technologies, Ltd. — NDA Secondary Org

  2. Jul 26, 2021

    Nestle — NDA Secondary Org

  3. Feb 10, 2022

    Solaris Pharma Corp — Marketing Organization

  4. Feb 10, 2022

    Donaldson Company — Marketing Organization

  5. Aug 22, 2023

    Encube Ethicals Pvt. Ltd. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewOct 20, 1971

Chemistry & pharmacology

Loading structure…

SMILES

CC(\C=C\C1=C(C)CCCC1(C)C)=C/C=C/C(C)=C/C(O)=O
Mol. weight
300.4351 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexene-1-yl)-2,4,6,8-nonatetraenoic acid (ecl)
  • 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexene-1-yl)-2,4,6,8-nonatetraenoic acid (ecl)
  • 8-(3',4'-dihydro-1'(2'h)-naphthalen-1'-ylidene)-3,7-dimethyl-2,4,6-octatrienoic acid
  • 9-cis-uab30
  • 9cuab30
  • 9cuab30
  • 9cuab30
  • (9z)-uab30
  • acide retinoique (french) (dsl)
  • acide retinoique (french) (dsl)
  • acticin
  • acticin
  • agn 100335
  • agn 100335
  • (all-e)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid
  • (all-e)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid
  • all-(e)-retinoic acid
  • all-(e)-retinoic acid
  • all-trans-beta-retinoic acid
  • all-trans-beta-retinoic acid
  • all trans retinoic acid
  • all trans retinoic acid
  • all trans retinoic acid
  • all trans-retinoic acid
  • all trans-retinoic acid
  • all-trans retinoic acid
  • all-trans retinoic acid
  • all-trans-retinoic acid
  • all-trans-retinoic acid
  • all-trans-retinoic acid
  • all-trans-tretinoin
  • all-trans-tretinoin
  • all-trans-vitamin a1 acid
  • all-trans-vitamin a1 acid
  • all-trans-vitamin a acid
  • all-trans-vitamin a acid
  • atra
  • atra
  • atralin
  • atralin
  • avita
  • avita
  • beta-retinoic acid
  • beta-retinoic acid
  • eudyna
  • eudyna
  • idp 121
  • idp-121
  • olcenon
  • renova
  • renova
  • retin-a
  • retin-a
  • retin-a
  • retinal
  • retinal
  • retin-a micro
  • retin-a micro
  • retinoic acid
  • retinoic acid
  • retinoic acid
  • retinoid 9cuab30
  • retinoid 9cuab30
  • retinoid 9cuab30
  • retionic acid
  • retionic acid
  • ro 1-5488
  • ro 1-5488
  • solage
  • solage
  • stieva-a
  • stieva-a
  • tocoretinate
  • tocoretinate
  • tocoretinate
  • tocoretinate
  • trans-retinoic acid
  • trans-retinoic acid
  • trans-retinoic acid
  • tretin m
  • tretin m
  • tretinoin
  • tretinoin
  • tretinoin
  • tretinoin
  • tretinoin
  • tretinoin
  • tretinoin
  • tretinoin
  • tretinoin
  • tretinoina
  • tretinoina
  • trétinoïne
  • trétinoïne
  • tretinoine (french) (einecs)
  • tretinoine (french) (einecs)
  • tretinoin potassium
  • tretinoin sodium
  • tretinoin tocoferil
  • tretinoin tocoferil
  • tretinoinum
  • tretinoinum
  • tretin-x
  • uab 30
  • uab-30
  • vesanoid
  • vesanoid
  • vesanoid
  • vitamin a acid
  • vitamin a acid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07296445Phase 3Jan 31, 2026SDK Therapeutics, Inc.
NCT07278908Phase 2/Phase 3 (Phase 3)Dec 31, 2025China Academy of Chinese Medical Sciences
NCT07079696Phase 2Sep 1, 2025Zhejiang University
NCT07084116Phase 2/Phase 3 (Phase 3)Jul 14, 2025Stanford University
NCT07187505N/AJul 1, 2025Anhui Medical University
NCT06841952N/AFeb 15, 2025Soochow University
NCT06706401Phase 3Jan 31, 2025Centre Leon Berard
NCT06528769Phase 2Dec 1, 2024Ohio State University
NCT06646666Phase 2Dec 1, 2024Jiao Tong University
NCT06703047Phase 2Nov 20, 2024Fudan University
NCT06787222Phase 2/Phase 3 (Phase 3)Nov 3, 2024University of Hasanuddin
NCT06484920Phase 2Oct 31, 2024Indiana University
NCT06371274N/AOct 15, 2024Zhejiang University
NCT06636981Phase 2Oct 10, 2024Fudan University
NCT06536413Phase 1/Phase 2 (Phase 2)Jul 29, 2024Methodist Cancer Center, Houston, Texas, State of Texas, The University of Texas, Dallas
NCT06728631Phase 2Jul 15, 2024Jiao Tong University
NCT06439888Phase 1/Phase 2 (Phase 2)Jul 11, 2024Institut Gustave Roussy
NCT06358677Phase 2Jun 21, 2024University of Utah
NCT07012811Phase 4Feb 12, 2024Tishreen University
NCT06213987Phase 3Feb 1, 2024Srinakharinwirot University
Showing 20 of 206 trials
Page 1 / 11

Organizations

Research & Development (219)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government251041991
Bausch Health CompaniesFor profit131142008
GaldermaFor profit7632006
Jiao Tong UniversityAcademic/Hospital7742012
Peking UniversityAcademic/Hospital7632012
CelgeneFor profit6022005
Cornell UniversityAcademic/Hospital6621999
GlaxoSmithKlineFor profit6132004
Gruppo Italiano Malattie EMatologiche dell'AdultoAcademic/Hospital6431993
Johnson and JohnsonFor profit6031998
University of Texas at HoustonAcademic/Hospital6621999
Harvard UniversityAcademic/Hospital5531997
University of UlmAcademic/Hospital5521998
Capital Medical UniversityAcademic/Hospital4012012
Government of ChinaGovernment4022012
Johns Hopkins UniversityAcademic/Hospital4432000
Medical Research CouncilGovernment4231994
PETHEMA FoundationAcademic/Hospital4411999
Shandong UniversityAcademic/Hospital4122012
Stiefel LaboratoriesFor profit4432007
219 organizations
Page 1 / 11

Marketing (36)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGJun 12, 2015
AllerganFor profitMKTGMar 22, 2010
AllerganFor profitSYNMar 22, 2010
Allergan PLC (2015)For profitMKTGJun 12, 2015
AlmirallFor profitMKTGDec 10, 1999
AlmirallFor profitNDA2Dec 10, 1999
Anchen Pharmaceuticals, IncFor profitMKTGOct 24, 2012
Barr LaboratoriesFor profitMKTGJun 21, 2007
Bausch Health CompaniesFor profitSYNNov 7, 2006
Bausch Health CompaniesFor profitSYNOct 20, 1971
Bausch Health CompaniesFor profitSYNJul 19, 1974
Bausch Health CompaniesFor profitNDA2Oct 20, 1971
Bausch Health CompaniesFor profitSYNJan 26, 1973
CheplaPharmFor profitNDA2Nov 22, 1995
Donaldson CompanyFor profitMKTGFeb 10, 2022
Dow Pharmaceutical SciencesFor profitNDA2Jul 26, 2007
Encube Ethicals Pvt. Ltd.For profitMKTGAug 22, 2023
GaldermaFor profitMKTGJan 18, 2002
GaldermaFor profitNDA—
GlaxoSmithKlineFor profitMKTGMar 22, 2010
Glenmark PharmaceuticalsFor profitMKTGDec 23, 2016
MedicisFor profitMKTGNov 7, 2006
MylanFor profitNDA2Jan 29, 1998
MylanFor profitSYNJan 14, 1997
MylanFor profitMKTGJul 17, 2013
NestleFor profitNDA2Jul 26, 2021
Padagis UsFor profitMKTGDec 24, 1998
Par PharmaceuticalsFor profitMKTGOct 24, 2012
PerrigoFor profitMKTGDec 24, 1998
Sol-Gel Technologies, Ltd.For profitNDA2Jul 26, 2021
Solaris Pharma CorpFor profitMKTGFeb 10, 2022
Sun PharmaceuticalsFor profitMKTGJan 22, 2019
Taro PharmaceuticalsFor profitMKTGJan 22, 2019
TevaFor profitMKTGJun 19, 1998
WockhardtFor profitMKTGJan 25, 1999
Zo Skin HealthFor profitMKTGSep 15, 2005