cortisone acetate

Trade name: cortone

Small moleculeapproved

Approved

Jun 13, 1950

Cortisone is a hormone that is FDA approved for the treatment of primary and secondary adrenocortical deficiency, rheumatic disorders, psoriasis, exfoliative dermatitis, bronchial asthma, allergic conjunctivitis, hemolytic anemia, enteritis, tuberculosis, trichnosis. Cortisone acetate binds to the cytosolic glucocorticoid receptor. After binding the receptor, the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes. Common adverse reactions include convulsions, increased intracranial pressure with papilledema, vertigo, headache, psychic disturbances, hirsuitism, glaucoma, exophthalmos. Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Cortisone is a natural steroid hormone. Its sulfate analog has been detected in in umbilical vein blood fetus plasma between 19 and 32 weeks of gestation with a significant increase at 29-30 weeks and in amniotic fluid. Base on the experiments with rats it was suggested that cortisone sulfate in mammals could be hydrolyzed enzymatically liberating sulfate ions from cortisone. Cortisone sulfate has been proposed for use as one of the glycosaminoglycan compound materials in a cartilage prosthesis and biological nasal bridge implant manufacture as well as auxiliary agent in powder aerosol composition for use in baby powder, dry shampoo, water-eczema remedy and antiperspirant. — NCATS

Clinical trial activity

16 trials · 29 clinical orgs · 17 marketing orgs

Phase 1
3
Phase 2
4
Phase 3
2
Phase 4
3

Earliest trial started Jan 1, 2000 (NCT03558971)

Timeline

1950s

  1. Jun 13, 1950

    Merck — Earliest FDA Approval

  2. Jun 13, 1950

    Merck — NDA Organization

  3. Jun 13, 1950

    Merck — NDA Secondary Org

  4. Nov 2, 1951

    Pharmacia & Upjohn — NDA Secondary Org

  5. Jan 14, 1952

    Panray Corp. — NDA Secondary Org

1970s

  1. Jan 3, 1972

    Teva — Marketing Organization

  2. Jun 13, 1972

    Hikma — Marketing Organization

  3. Jun 20, 1973

    Whiteworth Towne Paulsen — Marketing Organization

  4. Aug 31, 1973

    Barr Laboratories — Marketing Organization

  5. Oct 17, 1974

    Chartwell Pharmaceuticals — Marketing Organization

  6. Oct 17, 1974

    Lannett Company, Inc. — Marketing Organization

  7. Jan 22, 1975

    Everylife Foundation for Rare Diseases — Marketing Organization

  8. Feb 23, 1977

    Impax Laboratories — Marketing Organization

  9. Mar 7, 1978

    Watson Pharmaceuticals — Marketing Organization

2000s

  1. Sep 17, 2001

    Impax Laboratories — NDA Secondary Org

  2. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedPriority reviewJun 13, 1950

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CC(=O)[C@H]3[C@@H](CCC4=CC(=O)CC[C@]34C)[C@@H]1CC[C@]2(O)C(=O)CO
Mol. weight
360.444 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Discontinued

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • adrenalex
  • cortelan
  • cortelan
  • cortisone
  • cortisone
  • cortisone
  • cortisone
  • cortisone acetate
  • cortisone acetate
  • cortisone acetate
  • cortisone acetate
  • cortisone acetate
  • cortisone acetate
  • cortisone acetate
  • cortisone acetate
  • cortisone acetate
  • cortisone acetate
  • cortistab
  • cortistab
  • cortisyl
  • cortisyl
  • cortisyl
  • cortone
  • cortone
  • cortone
  • cortone acetate
  • cortone acetate
  • irisone acetate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05409027Phase 1Aug 5, 2021Sparrow Pharmaceuticals
NCT04921189Phase 2Jun 4, 2021Catholic University of Korea, Chung-Ang University, Ewha Womans University, Hanil General Hospital, Hanyang University, Sungkyunkwan University, University of Ulsan, Wonju Christian Hospital
NCT03951480N/AJun 30, 2019Centre Hospitalier Departemental Vendee
NCT02918136Phase 1Dec 1, 2016InGeneron, Inc., Sanford Health
NCT03760835Phase 4Aug 11, 2016University of Naples Frederico II
NCT02196155N/AJul 1, 2016Luzerner Kantonsspital, University of Bern
NCT03580148Phase 2/Phase 3 (Phase 3)Oct 8, 2015University of Toronto
NCT02855866N/ASep 1, 2013University of Burgundy
NCT03195933N/AJul 31, 2013Brain & Behavior Research Foundation, National Institute of Mental Health (NIMH), University of Wisconsin
NCT01771328Phase 2Feb 1, 2013University of Bergen
NCT02639039Phase 4Feb 1, 2013Scott and White Healthcare
NCT01447160Phase 3Oct 1, 2011Federal University of Sao Paulo, University of Sao Paulo
NCT01154361Phase 2Jun 29, 2010Technical University of Munich
NCT00951236N/AMay 1, 2009Thomas Jefferson University
NCT00279903Phase 1Nov 1, 2005Mayo Clinic
NCT03558971Phase 4Jan 1, 2000Helen Foundation, University of North Dakota
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (29)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Brain & Behavior Research FoundationAcademic/Hospital1012013
Catholic University of KoreaAcademic/Hospital1012021
Centre Hospitalier Departemental VendeeAcademic/Hospital1112019
Chung-Ang UniversityAcademic/Hospital1012021
Ewha Womans UniversityAcademic/Hospital1012021
Federal University of Sao PauloAcademic/Hospital1012011
Hanil General HospitalAcademic/Hospital1012021
Hanyang UniversityAcademic/Hospital1012021
Helen FoundationAcademic/Hospital1112000
InGeneron, Inc.For profit1112016
Luzerner KantonsspitalAcademic/Hospital1012016
Mayo ClinicAcademic/Hospital1112005
National Institute of Mental Health (NIMH)Government1012013
Sanford HealthAcademic/Hospital1012016
Scott and White HealthcareAcademic/Hospital1112013
Sparrow PharmaceuticalsFor profit1112021
Sungkyunkwan UniversityAcademic/Hospital1012021
Technical University of MunichAcademic/Hospital1112010
Thomas Jefferson UniversityAcademic/Hospital1112009
University of BergenAcademic/Hospital1112013
29 organizations
Page 1 / 2

Marketing (19)

OrganizationOrg typeRelationshipDate
Barr LaboratoriesFor profitMKTGAug 31, 1973
Chartwell PharmaceuticalsFor profitMKTGOct 17, 1974
Elkins SinnFor profitMKTG
Everylife Foundation for Rare DiseasesAcademic/HospitalMKTGJan 22, 1975
Heather PharmaFor profitMKTG
HikmaFor profitMKTGJun 13, 1972
Impax LaboratoriesFor profitMKTGFeb 23, 1977
Impax LaboratoriesFor profitNDA2Sep 17, 2001
Inwood LaboratoriesFor profitMKTG
Lannett Company, Inc.For profitMKTGOct 17, 1974
MerckFor profitNDAJun 13, 1950
MerckFor profitNDA2Jun 13, 1950
Panray Corp.For profitNDA2Jan 14, 1952
Pharmacia & UpjohnFor profitNDA2Nov 2, 1951
Puracap PharmaceuticalFor profitMKTG
TevaFor profitMKTGJan 3, 1972
VitarineFor profitMKTG
Watson PharmaceuticalsFor profitMKTGMar 7, 1978
Whiteworth Towne PaulsenFor profitMKTGJun 20, 1973