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desoximetasone

Trade name: topicort

Small moleculeapproved

Approved

Feb 28, 1977

Desoximetasone (Topicort®) is a topical anti-inflammatory glucocorticoid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and for the treatment of plaque psoriasis in patients 18 years of age or older. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. They play a role in cellular signaling, immune function, inflammation and protein regulation; however, the precise mechanism of action in psoriasis is unknown. The mechanism of anti-inflammatory activity of the topical corticosteroids is also unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. — NCATS

Clinical trial activity

21 trials · 8 clinical orgs · 26 marketing orgs

Phase 1
0
Phase 2
17
Phase 3
7
Phase 4
4

Earliest trial started Nov 1, 2009 (NCT01018134)

Timeline

1970s

  1. Feb 28, 1977

    Taro Pharmaceuticals — Earliest FDA Approval

  2. Feb 28, 1977

    Taro Pharmaceuticals — NDA Secondary Org

  3. Feb 28, 1977

    Taro Pharmaceuticals — NDA Organization

  4. Feb 28, 1977

    Taro Pharmaceuticals — Marketing Organization

1990s

  1. Apr 1, 1998

    Altana — Marketing Organization

2000s

  1. Jul 1, 2003

    Perrigo — Marketing Organization

  2. Jan 9, 2006

    Padagis Us — Marketing Organization

  3. Jan 1, 2009

    Taro Pharmaceuticals — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Taro Pharmaceuticals — Earliest Phase 3 Sponsor(trial)

  2. Jun 29, 2010

    Fougera — Marketing Organization

  3. Mar 10, 2011

    Akorn, Inc. — Marketing Organization

  4. Mar 10, 2011

    Epic Pharma Llc — Marketing Organization

  5. Sep 28, 2012

    Novartis — Marketing Organization

  6. Apr 11, 2013

    Sun Pharmaceuticals — NDA Secondary Org

  7. Sep 20, 2013

    Glenmark Pharmaceuticals — Marketing Organization

  8. Jun 12, 2015

    Sciegen Pharmaceticals — Marketing Organization

  9. Jun 12, 2015

    Saptalis Pharmaceuticals — Marketing Organization

  10. Sep 4, 2015

    Actavis — Marketing Organization

  11. Sep 4, 2015

    Allergan PLC (2015) — Marketing Organization

  12. Feb 25, 2016

    Pharmaceutical Associates — Marketing Organization

  13. Feb 25, 2016

    Teligent Pharmaceuticals — Marketing Organization

  14. May 10, 2016

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  15. Aug 12, 2016

    Rising Pharmaceuticals — Marketing Organization

  16. Aug 12, 2016

    ANDA Repository — Marketing Organization

  17. Dec 1, 2016

    Lupin — Marketing Organization

  18. Dec 23, 2016

    G & W Laboratories Inc. — Marketing Organization

  19. Dec 23, 2016

    ACP Nimble — Marketing Organization

  20. Sep 19, 2017

    Zydus Discovery DMCC — Marketing Organization

  21. Sep 28, 2018

    Cadila Healthcare — Marketing Organization

  22. Oct 23, 2018

    THE J MOLNER — Marketing Organization

2020s

  1. Mar 4, 2020

    Cosette — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFeb 28, 1977

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@H]1C(=O)CO
Mol. weight
376.4617 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • (11beta,16alpha)-9-fluoro-11,21-dihydroxy-16-methylpregna-1,4-diene-3,20-dione
  • (11beta,16alpha)-9-fluoro-11,21-dihydroxy-16-methylpregna-1,4-diene-3,20-dione
  • 9alpha-fluoro-16alpha-methyl-delta(1)-corticosterone
  • 9alpha-fluoro-16alpha-methyl-delta(1)-corticosterone
  • a-41-304
  • a-41-304
  • deoxymethasone
  • deoxymethasone
  • desoximetason
  • desoximetason
  • desoximetasona
  • desoximetasona
  • desoximetasone
  • desoximetasone
  • desoximetasone
  • desoximetasone
  • desoximetasone
  • desoximetasone
  • desoximetasone
  • desoximetasone
  • desoximetasone
  • desoximetasone
  • desoximetasone
  • désoximétasone
  • désoximétasone
  • desoximetasonum
  • desoximetasonum
  • desoximethasone
  • desoxymetasone
  • desoxymethasone
  • desoxymethasone
  • desoxymethasone
  • dsxs
  • hoe-304
  • hoe-304
  • r-2113
  • r-2113
  • stiedex
  • stiedex
  • stiedex lp
  • stiedex lpn
  • test product 10156
  • topicort
  • topicort
  • topicort
  • topicort lp
  • topicort lp

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03050294Phase 4Feb 1, 2017Wake Forest University
NCT02932878Phase 2Sep 2, 2016Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02985736Phase 4Sep 1, 2016Taro Pharmaceuticals, Windsor Dermatology
NCT02932891Phase 2Aug 1, 2016Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02933528Phase 2Jul 11, 2016Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02933502Phase 2Jul 11, 2016Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02933866Phase 3Mar 11, 2016Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02932462Phase 3Mar 1, 2016Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02983981Phase 4Mar 1, 2016Taro Pharmaceuticals, Windsor Dermatology
NCT02749656Phase 3Jan 1, 2016Mahidol University, Siriraj Hospital, SPS MEDICAL CO.,LTD.
NCT02601469Phase 2Sep 4, 2015Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02595073Phase 3Sep 4, 2015Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02618759Phase 3Aug 28, 2015Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02595008Phase 2Aug 28, 2015Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02413229Phase 2Apr 1, 2015Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT02340169Phase 4Jan 23, 2015Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT01703793Phase 2Sep 1, 2012Medicis
NCT01206660Phase 3Aug 1, 2010Taro Pharmaceuticals
NCT01206387Phase 3Aug 1, 2010Novum Pharmaceutical Research Services, Taro Pharmaceuticals
NCT01043393Phase 2Feb 1, 2010Taro Pharmaceuticals
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (8)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Taro PharmaceuticalsFor profit181632009
Novum Pharmaceutical Research ServicesFor profit13032010
Windsor DermatologyAcademic/Hospital2212016
Mahidol UniversityAcademic/Hospital1012016
MedicisFor profit1112012
Siriraj HospitalAcademic/Hospital1112016
SPS MEDICAL CO.,LTD.For profit1012016
Wake Forest UniversityAcademic/Hospital1112017
8 organizations
Page 1 / 1

Marketing (37)

OrganizationOrg typeRelationshipDate
ACP NimbleFor profitMKTGDec 23, 2016
ANDA RepositoryFor profitMKTGAug 12, 2016
ActavisFor profitMKTGSep 4, 2015
Akorn, Inc.For profitMKTGMar 10, 2011
Allergan PLC (2015)For profitMKTGSep 4, 2015
AltanaFor profitMKTGApr 1, 1998
Cadila HealthcareFor profitMKTGSep 28, 2018
CosetteFor profitMKTGMar 4, 2020
CosetteFor profitSYNMar 4, 2020
Epic Pharma LlcFor profitMKTGMar 10, 2011
FougeraFor profitMKTGJun 29, 2010
G & W Laboratories Inc.For profitMKTGDec 23, 2016
Glenmark PharmaceuticalsFor profitMKTGSep 20, 2013
Glenmark PharmaceuticalsFor profitSYNSep 20, 2013
LupinFor profitMKTGDec 1, 2016
LupinFor profitSYNDec 1, 2016
NovartisFor profitMKTGSep 28, 2012
Novel Anti-Infective Technologies, LLCFor profitMKTGMay 10, 2016
Padagis UsFor profitMKTGJul 1, 2003
Padagis UsFor profitMKTGJan 9, 2006
PerrigoFor profitSYNApr 20, 2015
PerrigoFor profitMKTGJul 1, 2003
Pharmaceutical AssociatesFor profitMKTGFeb 25, 2016
Rising PharmaceuticalsFor profitMKTGAug 12, 2016
Rising PharmaceuticalsFor profitSYNAug 12, 2016
Saptalis PharmaceuticalsFor profitMKTGJun 12, 2015
Sciegen PharmaceticalsFor profitMKTGJun 12, 2015
Sun PharmaceuticalsFor profitNDA2Apr 11, 2013
THE J MOLNERFor profitMKTGOct 23, 2018
Taro PharmaceuticalsFor profitNDA2Feb 28, 1977
Taro PharmaceuticalsFor profitSYNApr 11, 2013
Taro PharmaceuticalsFor profitNDAFeb 28, 1977
Taro PharmaceuticalsFor profitMKTGFeb 28, 1977
Teligent PharmaceuticalsFor profitMKTGFeb 25, 2016
Teligent PharmaceuticalsFor profitSYNFeb 25, 2016
Zydus Discovery DMCCFor profitMKTGSep 19, 2017
Zydus Discovery DMCCFor profitSYNSep 19, 2017