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desloratadine

Trade name: clarinex

Small moleculeapproved

Approved

Dec 21, 2001

Desloratadine is an active, descarboethoxy metabolite of loratadine. It acts by selective inhibition of H1 histamine receptor and thus provides relief to patients with allergic rhinitis and chronic idiopathic urticaria. Desloratadine was approved by FDA and it is currently marketed under the name Clarinex (among the others). — NCATS

Clinical trial activity

70 trials · 32 clinical orgs · 20 marketing orgs

Phase 1
6
Phase 2
31
Phase 3
26
Phase 4
27

Earliest trial started Feb 1, 2002 (NCT00867191)

Timeline

2000s

  1. Dec 21, 2001

    Schering-Plough — Earliest FDA Approval

  2. Dec 21, 2001

    Merck — NDA Secondary Org

  3. Dec 21, 2001

    Schering-Plough — NDA Organization

  4. Dec 21, 2001

    Organon — NDA Secondary Org

  5. Jan 1, 2002

    Merck — Earliest Phase 3 Sponsor(trial)

  6. Feb 8, 2002

    Schering — NDA Secondary Org

  7. Jan 1, 2005

    Dr. Reddy's Laboratories — Earliest Phase 1 Sponsor(trial)

  8. Jan 1, 2005

    Merck — Earliest Phase 2 Sponsor(trial)

  9. Aug 24, 2009

    Glenmark Pharmaceuticals — Marketing Organization

2010s

  1. Feb 19, 2010

    Orbion Pharms — Marketing Organization

  2. Feb 19, 2010

    Orchid Pharma — Marketing Organization

  3. Oct 25, 2010

    Lupin — Marketing Organization

  4. Nov 16, 2010

    Sun Pharmaceuticals — Marketing Organization

  5. Dec 3, 2010

    Sandoz — Marketing Organization

  6. Dec 3, 2010

    Novartis — Marketing Organization

  7. Dec 3, 2010

    Chartwell Pharmaceuticals — Marketing Organization

  8. Mar 8, 2011

    Dr. Reddy's Laboratories — Marketing Organization

  9. May 23, 2011

    Zydus Discovery DMCC — Marketing Organization

  10. Dec 22, 2011

    Perrigo — Marketing Organization

  11. Feb 10, 2012

    Mylan — Marketing Organization

  12. Feb 10, 2012

    Dash Pharms — Marketing Organization

  13. Apr 19, 2012

    Belcher Pharmaceuticals — Marketing Organization

  14. Apr 19, 2012

    AJENAT PHARMS — Marketing Organization

  15. May 26, 2016

    Taro Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • clarinex d 24 hour

    with pseudoephedrine

    Also known as clarinex-d 12 hour, desloratadine and pseudoephedrine sulfate 24 hour

Approval history

  • approvedDec 21, 2001

Chemistry & pharmacology

Loading structure…

SMILES

ClC1=CC=C2C(CCC3=C(N=CC=C3)C2=C4CCNCC4)=C1
Mol. weight
310.821 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 8-chloro-11-piperidin-4-ylidene-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine
  • 8-chloro-11-piperidin-4-ylidene-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine
  • 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo(5,6)cyclohepta(1,2-b)pyridine
  • 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo(5,6)cyclohepta(1,2-b)pyridine
  • aerius
  • aerius
  • aerius
  • aerius
  • azomyr
  • clarinex
  • clarinex
  • clarinex
  • clarinex
  • delopedil
  • descarboethoxyloratadine
  • descarboethoxyloratadine
  • descarboethoxyloratadine
  • descarboethoxyloratadine
  • descarboethoxyloratadine acetate
  • descarboethoxyloratidine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine
  • desloratadine / pseudophedrine sulphate
  • midetorin
  • neoclarityn
  • neoclarityn
  • neoclarityn
  • neoclarityn
  • sch 34117
  • sch 34117
  • sch-34117
  • sch-34117
  • sch-34117
  • sch-34117
  • sch-34117
  • sch-34117

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07109817Phase 2Nov 30, 2025Yeshiva University
NCT06272409Phase 3Feb 15, 2025EMS S/A
NCT06916884Phase 3Nov 11, 2024Laboratorios Silanes S.A. de C.V., Unidad de Medicina Especializada SMA
NCT06217367Phase 4Dec 5, 2023Lakehead University
NCT05214911Phase 3Oct 1, 2023Eurofarma Laboratorios S.A.
NCT05446480N/AJul 31, 2022University of Victoria
NCT05232825Phase 3May 2, 2022Roche
NCT04399525N/AOct 28, 2019Katholieke Universiteit Leuven
NCT04399148N/AJun 11, 2019Katholieke Universiteit Leuven
NCT06268470Phase 2Jun 1, 2018Chulalongkorn University
NCT02904304Phase 3Jan 1, 2018Ache Laboratorios Farmaceuticos S.A.
NCT02646020Phase 2Dec 1, 2015Sun Yat-Sen University
NCT02320396Phase 3Jan 1, 2015Merck
NCT01529242Phase 3Feb 1, 2014EMS S/A, University of Sao Paulo
NCT01529229Phase 3Nov 1, 2013EMS S/A, University of Sao Paulo
NCT01985789Phase 4Nov 1, 2013University of Saskatchewan
NCT01720485Phase 3Oct 1, 2013EMS S/A
NCT01916967Phase 3Aug 1, 2013Merck
NCT01918033Phase 3Aug 1, 2013Merck
NCT01916980Phase 3Aug 1, 2013Merck
Showing 20 of 70 trials
Page 1 / 4

Organizations

Research & Development (32)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit343432002
Dr. Reddy's LaboratoriesFor profit6612005
EMS S/AFor profit4412013
SFBC AnapharmFor profit4012006
Humboldt UniversityAcademic/Hospital3322006
ALK-Abello, S.A.For profit2212006
Katholieke Universiteit LeuvenAcademic/Hospital2212019
PharmaNet (2006)For profit2012005
University of Sao PauloAcademic/Hospital2012013
University of SaskatchewanAcademic/Hospital2222007
Ache Laboratorios Farmaceuticos S.A.For profit1112018
Chulalongkorn UniversityAcademic/Hospital1112018
Essex PharmaFor profit1012007
Eurofarma Laboratorios S.A.For profit1112023
Faes Farma, S.A.For profit1112003
GenentechFor profit1112009
Grupo de Alergología Clínica y ExperimentalAcademic/Hospital1112013
Hoosier Cancer Research NetworkAcademic/Hospital1112005
Iuliu Hatieganu University of Medicine and PharmacyAcademic/Hospital1112009
Johannes Gutenburg UniversityAcademic/Hospital1012009
32 organizations
Page 1 / 2

Marketing (25)

OrganizationOrg typeRelationshipDate
AJENAT PHARMSFor profitMKTGApr 19, 2012
Belcher PharmaceuticalsFor profitMKTGApr 19, 2012
Chartwell PharmaceuticalsFor profitMKTGDec 3, 2010
Dash PharmsFor profitMKTGFeb 10, 2012
Dr. Reddy's LaboratoriesFor profitMKTGMar 8, 2011
Dr. Reddy's LaboratoriesFor profitSYNJul 12, 2010
Glenmark PharmaceuticalsFor profitMKTGAug 24, 2009
LupinFor profitMKTGOct 25, 2010
MerckFor profitNDA2Dec 21, 2001
MylanFor profitMKTGFeb 10, 2012
NovartisFor profitMKTGDec 3, 2010
Orbion PharmsFor profitMKTGFeb 19, 2010
Orchid PharmaFor profitMKTGFeb 19, 2010
OrganonFor profitNDA2Dec 21, 2001
OrganonFor profitSYNFeb 1, 2006
PerrigoFor profitMKTGDec 22, 2011
PerrigoFor profitSYNDec 22, 2011
SandozFor profitMKTGDec 3, 2010
ScheringFor profitNDA2Feb 8, 2002
Schering-PloughFor profitNDADec 21, 2001
Sun PharmaceuticalsFor profitMKTGNov 16, 2010
Taro PharmaceuticalsFor profitMKTGMay 26, 2016
Taro PharmaceuticalsFor profitSYNJun 30, 2015
Taro PharmaceuticalsFor profitSYNMay 26, 2016
Zydus Discovery DMCCFor profitMKTGMay 23, 2011