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clobetasol

Trade name: dermovate

mAbapproved

Approved

Dec 27, 1985

CLOBETASOL, a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than fluocinonide, it is used topically in the treatment of psoriasis but may cause marked adrenocortical suppression. For short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Like other topical corticosteroids, clobetasol has anti-inflammatory, antipruritic, and vasoconstrictive properties. It is a very high potency topical corticosteroid that should not be used with occlusive dressings. Topical corticosteroids share anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Initially, however, clobetasol, like other corticosteroids, bind to the glucocorticoid receptor, which complexes, enters the cell nucleus and modifies genetic transcription (transrepression/transactivation). — NCATS

Clinical trial activity

109 trials · 108 clinical orgs · 48 marketing orgs

Phase 1
22
Phase 2
46
Phase 3
27
Phase 4
25

Earliest trial started Aug 1, 2002 (NCT01453686)

Timeline

1980s

  1. Dec 27, 1985

    Glaxo — Earliest FDA Approval

  2. Dec 27, 1985

    Fougera — NDA Secondary Org

  3. Dec 27, 1985

    Glaxo — NDA Organization

1990s

  1. Feb 16, 1994

    ACP Nimble — Marketing Organization

  2. Feb 16, 1994

    G & W Laboratories Inc. — Marketing Organization

  3. Feb 16, 1994

    Teva — Marketing Organization

  4. Feb 16, 1994

    Cosette — Marketing Organization

  5. Aug 3, 1994

    Actavis — Marketing Organization

  6. Mar 31, 1995

    Hikma — Marketing Organization

  7. Jul 8, 1996

    Taro Pharmaceuticals — Marketing Organization

  8. Sep 30, 1996

    Fougera — Marketing Organization

  9. Oct 31, 1997

    Perrigo — Marketing Organization

  10. Oct 31, 1997

    Padagis Us — Marketing Organization

  11. Aug 12, 1998

    Aurobindo Pharma — Marketing Organization

  12. Aug 12, 1998

    Mylan — NDA Secondary Org

  13. Nov 13, 1998

    Wockhardt — Marketing Organization

2000s

  1. Aug 22, 2001

    Ani Pharmaceuticals — Marketing Organization

  2. Aug 22, 2001

    Novast Labs — Marketing Organization

  3. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  5. Feb 5, 2004

    Galderma — NDA Secondary Org

  6. Jan 1, 2005

    Actavis — Earliest Phase 1 Sponsor(trial)

  7. Aug 5, 2005

    Tolmar Inc. — Marketing Organization

2010s

  1. Jun 16, 2011

    Paddock Laboratories — Marketing Organization

  2. Jul 2, 2012

    Sun Pharmaceuticals — Marketing Organization

  3. Nov 23, 2015

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  4. Nov 29, 2016

    Teligent Pharmaceuticals — Marketing Organization

  5. Feb 16, 2017

    Zydus Discovery DMCC — Marketing Organization

  6. Mar 20, 2017

    Glenmark Pharmaceuticals — Marketing Organization

  7. Apr 28, 2017

    Akorn, Inc. — Marketing Organization

  8. Jul 31, 2017

    Ingenus Pharmaceuticals — Marketing Organization

  9. Sep 22, 2017

    Lupin — Marketing Organization

  10. Oct 25, 2017

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  11. Oct 25, 2017

    Neogen — Marketing Organization

  12. Oct 27, 2017

    Hi Tech Pharmaceuticals — Marketing Organization

  13. Nov 28, 2017

    Encore Dermatology — NDA Secondary Org

  14. Nov 28, 2017

    Primus Pharmaceuticals — Marketing Organization

  15. Nov 28, 2017

    Primus Pharmaceuticals — NDA Secondary Org

  16. Apr 17, 2018

    Apotex — Marketing Organization

  17. Apr 17, 2018

    Exeltis — Marketing Organization

  18. Aug 21, 2018

    Amneal Pharmaceuticals — Marketing Organization

  19. Oct 26, 2018

    Epic Pharma Llc — Marketing Organization

  20. Jan 11, 2019

    Rising Pharmaceuticals — Marketing Organization

  21. Jan 11, 2019

    Solaris Pharma Corp — Marketing Organization

  22. Mar 4, 2019

    Alembic — Marketing Organization

  23. Sep 24, 2019

    Cadila Healthcare — Marketing Organization

  24. Oct 2, 2019

    Saptalis Pharmaceuticals — Marketing Organization

  25. Oct 28, 2019

    Torrent Pharmaceuticals Limited — Marketing Organization

  26. Nov 15, 2019

    Encube Ethicals Pvt. Ltd. — Marketing Organization

2020s

  1. Feb 8, 2021

    Prinston Inc — Marketing Organization

  2. Mar 26, 2021

    Glasshouse Pharmaceuticals — Marketing Organization

  3. Mar 26, 2021

    Pharmaceutical Associates — Marketing Organization

  4. Mar 26, 2021

    Chartwell Pharmaceuticals — Marketing Organization

  5. Feb 17, 2022

    Quagen Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 27, 1985

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@@]1(O)C(=O)CCl
Mol. weight
410.907 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

No

Topical

Yes

Black box warning

Sources

Also known as

  • 21-chloro-11-dehydrobetamethasone
  • 21-chloro-11-dehydro-betamethasone-17-butyrate
  • 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate
  • 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate
  • cci-4725
  • cci-4725
  • cci 5537
  • cci 5537
  • clarelux
  • clarelux
  • clobaderm
  • clobavate
  • clobet
  • clobetasol
  • clobetasol
  • clobetasol
  • clobetasol
  • clobetasol
  • clobetasol 17-propanoate
  • clobetasol 17-propanoate
  • clobetasol 17-propionate
  • clobetasol 17-propionate
  • clobetasol 17-propionate
  • clobetasol 17-propionate
  • clobetasol 17-propionate
  • clobetasol 17-propionate
  • clobetasol propionate
  • clobetasol propionate
  • clobetasol propionate
  • clobetasol propionate
  • clobetasol propionate
  • clobetasol propionate
  • clobetasol propionate
  • clobetasol propionate
  • clobetasol propionate e
  • clobetasol propionate e
  • clobetasol propionate (emollient)
  • clobetasol propionate (emollient)
  • clobetasone
  • clobetasone
  • clobetasone
  • clobetasone
  • clobetasone 17-butyrate
  • clobetasone 17-butyrate
  • clobetasone butyrate
  • clobetasone butyrate
  • clobetasone butyrate
  • clobetasone butyrate
  • clobetasone butyrate
  • clobetasone butyrate
  • clobetasone butyrate
  • clobex
  • clobex
  • clobex
  • cloburate
  • cloburate-n
  • clofenazon
  • cormax
  • cormax
  • dermovate
  • dermovate
  • dermovate nn
  • dfd06
  • embeline
  • embeline
  • embeline e
  • embeline e
  • emovate
  • etrivex
  • eumovate
  • eumovate
  • eumovate
  • eumovate n
  • gr 2/1214
  • gr 2/1214
  • gr 2/925
  • gr 2/925
  • m195
  • m195
  • olux
  • olux
  • olux e
  • olux e
  • temovate
  • temovate
  • temovate
  • temovate e
  • temovate e
  • trimovate
  • trimovate
  • trimovate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07276802Phase 4Dec 5, 2025Research Insight LLC
NCT07278999N/ADec 1, 2025Silesian University of Medicine
NCT06856590N/AFeb 20, 2025Gazi University
NCT06504160Phase 2Dec 15, 2024National Institute of Allergy and Infectious Diseases (NIAID), National Jewish Health, Rho, Inc., University of California, San Diego
NCT06230757Phase 2Jul 8, 2024University of Colorado, University of Colorado, Denver
NCT06135402N/ANov 10, 2023Cantonal Hospital Winterthur
NCT06042647Phase 4Jul 13, 2023Dermatology Consulting Services, High Point NC
NCT05724446Phase 3Dec 12, 2022Salvat
NCT05706870Phase 2Dec 7, 2022GEN ILAC, GEN İlaç ve Sağlık Ürünleri A.Ş., MonitorCRO
NCT05364515Phase 3Oct 31, 2022Fundación Eduardo Anitua
NCT05243563Phase 2/Phase 3 (Phase 3)Apr 13, 2022University of South Alabama
NCT05428202Phase 1Mar 28, 2022Erciyes University, MonitorCRO
NCT06555497Early Phase 1 (Phase 1)Jan 1, 2022Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
NCT05010421Phase 3Nov 2, 2021Ruhr University Bochum
NCT04951206Phase 4Oct 1, 2021Georgetown University, Patty Brisben Foundation For Women's Sexual Health, Society of Gynecologic Surgeons
NCT04810962Phase 3Mar 16, 2021Formosa Pharmaceuticals, Inc.
NCT04685031Phase 1/Phase 2 (Phase 2)Feb 1, 2021Komar University of Science and Technology
NCT04739709Phase 3Jan 11, 2021Formosa Pharmaceuticals, Inc.
NCT04649697Phase 3Dec 1, 2020Cairo University
NCT04364555Phase 2/Phase 3 (Phase 3)May 31, 2020Lund University, Malmö University
Showing 20 of 109 trials
Page 1 / 6

Organizations

Research & Development (108)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GaldermaFor profit111022006
GlaxoSmithKlineFor profit8242004
Leo PharmaFor profit8732008
Dr. Reddy's LaboratoriesFor profit4422014
Stiefel LaboratoriesFor profit4412007
BayerFor profit3312013
Formosa Pharmaceuticals, Inc.For profit3322019
Mahidol UniversityAcademic/Hospital3322010
SalvatFor profit3312020
University of ParisAcademic/Hospital3332008
ActavisFor profit2212005
AmgenFor profit2212010
Cairo UniversityAcademic/Hospital2222016
Fifth Avenue Eye AssociatesAcademic/Hospital2012020
Georgetown UniversityAcademic/Hospital2222015
Icahn School of Medicine at Mount SinaiAcademic/Hospital2022009
Mayo ClinicAcademic/Hospital2122007
MonitorCROFor profit2022022
National Cancer Institute (NCI)Government2112012
NeoStrata Company, Inc.For profit2212007
108 organizations
Page 1 / 6

Marketing (67)

OrganizationOrg typeRelationshipDate
ACP NimbleFor profitMKTGFeb 16, 1994
ActavisFor profitMKTGAug 3, 1994
Akorn, Inc.For profitMKTGApr 28, 2017
AlembicFor profitMKTGMar 4, 2019
AlembicFor profitSYNMar 4, 2019
Amneal PharmaceuticalsFor profitSYNAug 21, 2018
Amneal PharmaceuticalsFor profitMKTGAug 21, 2018
Ani PharmaceuticalsFor profitSYNAug 22, 2001
Ani PharmaceuticalsFor profitMKTGAug 22, 2001
ApotexFor profitSYNApr 17, 2018
ApotexFor profitMKTGApr 17, 2018
Aurobindo PharmaFor profitMKTGAug 12, 1998
Cadila HealthcareFor profitMKTGSep 24, 2019
Chartwell PharmaceuticalsFor profitMKTGMar 26, 2021
CosetteFor profitMKTGFeb 16, 1994
Encore DermatologyFor profitNDA2Nov 28, 2017
Encube Ethicals Pvt. Ltd.For profitMKTGNov 15, 2019
Epic Pharma LlcFor profitMKTGOct 26, 2018
ExeltisFor profitMKTGApr 17, 2018
ExeltisFor profitSYNApr 17, 2018
FougeraFor profitNDA2Dec 27, 1985
FougeraFor profitMKTGSep 30, 1996
G & W Laboratories Inc.For profitMKTGFeb 16, 1994
GaldermaFor profitNDA2Feb 5, 2004
GaldermaFor profitSYNJul 24, 2003
Glasshouse PharmaceuticalsFor profitMKTGMar 26, 2021
GlaxoFor profitNDADec 27, 1985
Glenmark PharmaceuticalsFor profitMKTGMar 20, 2017
Glenmark PharmaceuticalsFor profitSYNApr 18, 2018
Hi Tech PharmaceuticalsFor profitSYNMar 31, 1995
Hi Tech PharmaceuticalsFor profitMKTGOct 27, 2017
HikmaFor profitMKTGMar 31, 1995
Ingenus PharmaceuticalsFor profitMKTGJul 31, 2017
LupinFor profitMKTGSep 22, 2017
Macleods Pharmaceuticals, LtdFor profitMKTGOct 25, 2017
MylanFor profitSYNAug 12, 1998
MylanFor profitNDA2Aug 12, 1998
MylanFor profitSYNMay 19, 2020
NeogenFor profitMKTGOct 25, 2017
Novast LabsFor profitMKTGAug 22, 2001
Novel Anti-Infective Technologies, LLCFor profitMKTGNov 23, 2015
Padagis UsFor profitMKTGMar 10, 2008
Padagis UsFor profitMKTGOct 31, 1997
Paddock LaboratoriesFor profitMKTGJun 16, 2011
PerrigoFor profitMKTGOct 31, 1997
PerrigoFor profitSYNMar 10, 2008
PerrigoFor profitSYNAug 14, 2012
Pharmaceutical AssociatesFor profitMKTGMar 26, 2021
Primus PharmaceuticalsFor profitMKTGNov 28, 2017
Primus PharmaceuticalsFor profitNDA2Nov 28, 2017
Prinston IncFor profitMKTGFeb 8, 2021
Quagen PharmaFor profitMKTGFeb 17, 2022
Rising PharmaceuticalsFor profitMKTGJan 11, 2019
Saptalis PharmaceuticalsFor profitMKTGOct 2, 2019
Solaris Pharma CorpFor profitMKTGJan 11, 2019
Sun PharmaceuticalsFor profitMKTGJul 2, 2012
Taro PharmaceuticalsFor profitSYNMar 25, 2021
Taro PharmaceuticalsFor profitMKTGJul 8, 1996
Taro PharmaceuticalsFor profitSYNOct 4, 2018
Teligent PharmaceuticalsFor profitSYNNov 29, 2016
Teligent PharmaceuticalsFor profitMKTGNov 29, 2016
TevaFor profitMKTGFeb 16, 1994
Tolmar Inc.For profitMKTGAug 5, 2005
Torrent Pharmaceuticals LimitedFor profitMKTGOct 28, 2019
WockhardtFor profitMKTGNov 13, 1998
Zydus Discovery DMCCFor profitMKTGFeb 16, 2017
Zydus Discovery DMCCFor profitSYNSep 24, 2019