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ciclesonide

Trade name: alvesco

Small moleculeapproved

Approved

Oct 20, 2006

Ciclesonide is a glucocorticoid receptor agonist indicated for the treatment of allergic rhinitis (Omnaris nasal spray) and asthma (Alvesco). It was also developed by Byk Gulden for chronic obstructive pulmonary disease (COPD), but no development had been reported for this indication since 1999. Ciclesonide is a pro-drug and rapidly metabolized to C21-desisobutyryl-ciclesonide which is more potent toward GR receptor than the parent drug. — NCATS

Clinical trial activity

77 trials · 55 clinical orgs · 6 marketing orgs

Phase 1
4
Phase 2
59
Phase 3
53
Phase 4
11

Earliest trial started Dec 1, 2000 (NCT00270348)

Timeline

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  3. Oct 20, 2006

    Earliest FDA Approval

  4. Oct 20, 2006

    Covis — Marketing Organization

  5. Oct 20, 2006

    AstraZeneca — NDA Secondary Org

  6. Oct 20, 2006

    Covis — NDA Secondary Org

  7. Oct 20, 2006

    Azurity — Marketing Organization

  8. Nov 21, 2007

    Nycomed — NDA Secondary Org

  9. Nov 21, 2007

    Hafslund — NDA Secondary Org

  10. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  11. Jan 10, 2008

    Altana — First NDA Organization

  12. Jan 10, 2008

    Altana — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedOct 20, 2006

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)C(=O)OCC(=O)[C@@]12O[C@@H](O[C@@H]1C[C@H]3[C@@H]4CCC5=CC(=O)C=C[C@]5(C)[C@H]4[C@@H](O)C[C@]23C)C6CCCCC6
Mol. weight
540.6876 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Prodrug

Sources

Also known as

  • alvesco
  • alvesco
  • alvesco
  • alvesco
  • alvesco
  • alvesco 160
  • alvesco 80
  • ave2635a
  • ciclesonide
  • ciclesonide
  • ciclesonide
  • ciclesonide
  • ciclesonide
  • ciclesonide
  • ciclesonide
  • ciclesonide
  • ciclesonide
  • ciclesonide
  • ciclesonide
  • omnaris
  • omnaris
  • omnaris
  • omnaris
  • (r)-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with cyclohexanecarboxaldehyde, 21-isobutyrate
  • rpr-251526
  • rpr-251526
  • zetonna
  • zetonna

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06589245Phase 1Feb 1, 2025National Institutes of Health (NIH), University of Kansas, University of Pittsburgh
NCT04920838Phase 2/Phase 3 (Phase 3)Apr 12, 2021Alliance for International Medical Action, Centre Muraz, Government of France, Institut National de la Santé Et de la Recherche Médicale, France, Programme PACCI Abidjan, University of Barcelona, University of Bordeaux
NCT04435795Phase 2/Phase 3 (Phase 3)Jun 25, 2020McGill University
NCT04416399Phase 2May 30, 2020University of Oxford
NCT04377711Phase 3May 26, 2020Covis
NCT04381364Phase 2May 15, 2020Danderyds Hospital, Karolinska Institute
NCT04330586Phase 2Apr 1, 2020Korea University
NCT02665754Phase 1Jul 1, 2016Gachon University, Korea Research Foundation
NCT02665806Phase 3Jan 1, 2016Isfahan University, University of Tehran
NCT02155881Phase 3Aug 1, 2014AstraZeneca
NCT01654536Phase 4Sep 1, 2012Sunovion
NCT01550471Phase 4Mar 1, 2012Allegheny Health Network
NCT01455194Phase 3Nov 1, 2011AstraZeneca
NCT01458275Phase 3Nov 1, 2011Sunovion
NCT01451541Phase 3Oct 1, 2011Sunovion
NCT01401465Phase 3Jul 1, 2011Sunovion
NCT01378429Phase 3Jul 1, 2011Sunovion
NCT01371786Phase 1Jun 1, 2011Sunovion
NCT01248065Phase 3Apr 1, 2011Case Western Reserve University, Duke University, Emory University, Harvard University, National Heart, Lung, and Blood Institute (NHLBI), North Carolina Clinical Research, Northwestern University, Pennsylvania State University, Rush University, University of California, San Francisco, University of Chicago, University of Colorado, Denver, University of Illinois at Chicago, University of Pittsburgh, University of Virginia, University of Wisconsin, Wake Forest University, Washington University in St. Louis
NCT02273817Phase 3Mar 1, 2011Apotex
Showing 20 of 77 trials
Page 1 / 4

Organizations

Research & Development (55)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit383832002
SunovionFor profit131232008
SanofiFor profit5522000
TakedaFor profit4022000
Boehringer IngelheimFor profit2222007
University of ChicagoAcademic/Hospital2122009
University of PittsburghAcademic/Hospital2022011
Allegheny Health NetworkAcademic/Hospital1112012
Allergy & Asthma Medical Group & Research CenterAcademic/Hospital1112006
Alliance for International Medical ActionAcademic/Hospital1012021
ApotexFor profit1112011
Case Western Reserve UniversityAcademic/Hospital1012011
Centre MurazAcademic/Hospital1012021
CovisFor profit1112020
Danderyds HospitalAcademic/Hospital1012020
Duke UniversityAcademic/Hospital1012011
Emory UniversityAcademic/Hospital1012011
Gachon UniversityAcademic/Hospital1112016
Government of FranceGovernment1112021
GrunenthalFor profit1112010
55 organizations
Page 1 / 3

Marketing (7)

OrganizationOrg typeRelationshipDate
AltanaFor profitNDAJan 10, 2008
AstraZenecaFor profitNDA2Oct 20, 2006
AzurityFor profitMKTGOct 20, 2006
CovisFor profitMKTGOct 20, 2006
CovisFor profitNDA2Oct 20, 2006
HafslundFor profitNDA2Nov 21, 2007
NycomedFor profitNDA2Nov 21, 2007