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azelastine

Trade name: astelin

Small moleculeapproved

Approved

Nov 1, 1996

Azelastine, a phthalazine derivative, is an antihistamine and mast cell stabilizer. Azelastine is oxidatively metabolized to the principal active metabolite, desmethylazelastine, by the cytochrome P450 enzyme system. It is indicated for the relief of the symptoms of seasonal allergic rhinitis and perennial allergic rhinitis. The most common adverse reactions are: pyrexia, dysgeusia, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, upper respiratory infection, cough, rhinalgia, vomiting, otitis media, contact dermatitis, and oropharyngeal pain. Concurrent use of Azelastine with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur. — NCATS

Clinical trial activity

58 trials · 55 clinical orgs · 30 marketing orgs

Phase 1
5
Phase 2
33
Phase 3
25
Phase 4
18

Earliest trial started Mar 1, 2005 (NCT00117832)

Timeline

1990s

  1. Nov 1, 1996

    Mylan — Earliest FDA Approval

  2. Nov 1, 1996

    Mylan — NDA Organization

  3. Nov 1, 1996

    Mylan — NDA Secondary Org

  4. Nov 1, 1996

    Mylan — Marketing Organization

  5. Nov 1, 1996

    Rising Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

  3. Oct 15, 2008

    Viatris — Marketing Organization

  4. Apr 30, 2009

    Apotex — Marketing Organization

  5. Aug 31, 2009

    Meda Pharmaceuticals — Marketing Organization

  6. Aug 31, 2009

    Meda Pharmaceuticals — NDA Secondary Org

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jun 21, 2010

    Sun Pharmaceuticals — Marketing Organization

  3. May 31, 2012

    Sandoz — Marketing Organization

  4. May 31, 2012

    Novartis — Marketing Organization

  5. May 8, 2014

    Perrigo — Marketing Organization

  6. May 8, 2014

    Padagis Us — Marketing Organization

  7. Oct 24, 2014

    West-Ward Pharmaceutical — Marketing Organization

  8. Oct 24, 2014

    Hikma — Marketing Organization

  9. Jul 28, 2015

    Esteve Labs — Marketing Organization

  10. Jul 28, 2015

    Bionpharma Inc — Marketing Organization

  11. Nov 8, 2016

    Akorn, Inc. — Marketing Organization

  12. Nov 8, 2016

    Epic Pharma Llc — Marketing Organization

  13. Mar 17, 2017

    Upsher-Smith Laboratories — Marketing Organization

  14. Aug 14, 2017

    Zydus Discovery DMCC — Marketing Organization

  15. Aug 18, 2017

    Alkem Labs Ltd — Marketing Organization

  16. Aug 28, 2017

    Amneal Pharmaceuticals — Marketing Organization

  17. Mar 20, 2019

    Alembic — Marketing Organization

  18. Mar 29, 2019

    Somerset Pharmaceuticals — Marketing Organization

  19. May 17, 2019

    Hi Tech Pharmaceuticals — Marketing Organization

  20. Aug 23, 2019

    Saptalis Pharmaceuticals — Marketing Organization

  21. Aug 23, 2019

    Sciegen Pharmaceticals — Marketing Organization

2020s

  1. Feb 25, 2020

    Gland Pharma Ltd — Marketing Organization

  2. Feb 25, 2020

    Fosun — Marketing Organization

  3. May 8, 2020

    Aurobindo Pharma — Marketing Organization

  4. Jun 17, 2021

    Bayer — Marketing Organization

  5. Jun 17, 2021

    Bayer — NDA Secondary Org

  6. Apr 8, 2025

    Teva — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • dymista

    with fluticasone

    Also known as fluticasone nasal 50 mcg/inh nasal spray, azelastine nasal 140 mcg/inh nasal spray

Approval history

  • approvedNov 1, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CN1CCCC(n2nc(Cc3ccc(Cl)cc3)c3ccccc3c2=O)CC1
Mol. weight
381.91 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 4-((4-chlorophenyl)methyl)-2- (hexahydro-1-methyl-1h-azepin-4-yl)-1(2h)- phthalazinone hcl
  • 4-(p-chlorobenzyl)-2-(hexahydro-1-methyl-1h-azepin-4-yl)-1-(2h)-phthalazinone
  • 4-(p-chlorobenzyl)-2-(hexahydro-1-methyl-1h-azepin-4-yl)-1-(2h)-phthalazinone
  • 4-(p-chlorobenzyl)-2-(n-methylperhydroazepinyl-(4))-1-(2h)-phthalazinone
  • a 5610
  • a-5610
  • a-5610
  • a-5610
  • afluon
  • allergodil
  • asta medica brand of azelastine hydrochloride
  • astelin
  • astelin
  • astelin
  • astelin
  • astepro
  • astepro
  • azelastina
  • azelastina
  • azelastine
  • azelastine
  • azelastine
  • azelastine
  • azelastine
  • azelastine
  • azelastine
  • azelastine
  • azelastine
  • azelastine
  • azelastine hcl
  • azelastine hcl
  • azelastine hcl
  • azelastine hydrochloride
  • azelastine hydrochloride
  • azelastine hydrochloride
  • azelastine hydrochloride
  • azelastine hydrochloride
  • azelastine hydrochloride
  • azelastinum
  • azelastinum
  • azeptin
  • bayer brand of azelastine hydrochloride
  • corifina
  • dagra brand of azelastine hydrochloride
  • dymista
  • e-0659
  • e-0659
  • loxin
  • mann brand of azelastine hydrochloride
  • muro brand of azelastine
  • optilast
  • optilast
  • optilast
  • optivar
  • optivar
  • optivar
  • orion brand of azelastine hydrochloride
  • rhinolast
  • rhinolast
  • rhinolast
  • rhinolast allergy
  • sanfer brand of azelastine hydrochloride
  • viatris brand of azelastine hydrochloride
  • vividrin akut azelastin
  • w-2979m
  • w-2979m
  • wallace brand of azelastine hydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06126952Phase 2Oct 30, 2023Cliantha Research Limited, Meda Pharmaceuticals
NCT05684380Phase 3Sep 30, 2023EMS S/A
NCT06008860Phase 4Jul 1, 2023University of Chicago
NCT05887843Phase 1Jun 8, 2023Sandoz
NCT06800274Phase 4Apr 21, 2023University of Brescia
NCT06180083Phase 1Mar 24, 2023Humanis Saglık Anonim Sirketi
NCT06212973Phase 3Mar 13, 2023Zhaoke (Guangzhou) Pharmaceutical Limited
NCT05590598Phase 3Jan 24, 2023Sandoz
NCT05626621Phase 4Dec 31, 2022University of Chicago
NCT05311475Phase 3Apr 4, 2022Sandoz
NCT05080322Phase 4Nov 1, 2021Hebei University, Huazhong University of Science and Technology, University of Barcelona, Xiamen University
NCT04729517Phase 3Apr 20, 2021Abdi Ibrahim Pharmaceuticals, Ankara Yildirim Beyazıt University, Antalya Training and Govermental Hospital, Dokuz Eylul University, Firat University, Istanbul University, Kahramanmaras Sutcu Imam University, Uludag University, University of Ankara
NCT04817800Phase 1/Phase 2 (Phase 2)Mar 25, 2021RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.
NCT04601324Phase 4Dec 15, 2020St. Paul's Sinus Centre
NCT04652245Phase 4Dec 14, 2020Cliantha Research Limited, Meda Pharmaceuticals
NCT06051786Phase 2Aug 20, 2020National Taiwan University, Synmosa Biopharma Corp.
NCT04264637Phase 3Feb 20, 2020Bayer
NCT04561687N/AJan 16, 2020Shiraz University
NCT03599791Phase 3Jun 29, 2018Meda Pharmaceuticals
NCT03004131Phase 4Jan 7, 2017Meda
Showing 20 of 58 trials
Page 1 / 3

Organizations

Research & Development (55)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MedaFor profit201942006
University of ChicagoAcademic/Hospital4422005
AlconFor profit3312008
Meda PharmaceuticalsFor profit3332018
SandozFor profit3322022
BayerFor profit2222007
Cliantha Research LimitedFor profit2022020
ClinResearch, GmbHFor profit2012010
GlaxoSmithKlineFor profit2122005
Prolytic GmbHFor profit2012010
University of DundeeAcademic/Hospital2212010
Abdi Ibrahim PharmaceuticalsFor profit1112021
Allied Research InternationalFor profit1012008
Ankara Yildirim Beyazıt UniversityAcademic/Hospital1012021
Antalya Training and Govermental HospitalAcademic/Hospital1012021
ApotexFor profit1112013
Association Asthma, BulgariaAcademic/Hospital1112015
AstraZenecaFor profit1112006
Dokuz Eylul UniversityAcademic/Hospital1012021
EMS S/AFor profit1112023
55 organizations
Page 1 / 3

Marketing (46)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGNov 8, 2016
AlembicFor profitMKTGMar 20, 2019
AlembicFor profitSYNMar 20, 2019
Alkem Labs LtdFor profitMKTGAug 18, 2017
Amneal PharmaceuticalsFor profitMKTGAug 28, 2017
Amneal PharmaceuticalsFor profitSYNAug 28, 2017
ApotexFor profitMKTGApr 30, 2009
ApotexFor profitSYNApr 28, 2017
Aurobindo PharmaFor profitMKTGMay 8, 2020
Aurobindo PharmaFor profitSYNJan 27, 2025
BayerFor profitMKTGJun 17, 2021
BayerFor profitMKTGJun 17, 2021
BayerFor profitNDA2Jun 17, 2021
Bionpharma IncFor profitMKTGJul 28, 2015
Epic Pharma LlcFor profitMKTGNov 8, 2016
Esteve LabsFor profitMKTGJul 28, 2015
Esteve LabsFor profitSYNJul 28, 2015
FosunFor profitMKTGFeb 25, 2020
Gland Pharma LtdFor profitMKTGFeb 25, 2020
Gland Pharma LtdFor profitSYNFeb 25, 2020
Hi Tech PharmaceuticalsFor profitMKTGMay 17, 2019
HikmaFor profitMKTGOct 24, 2014
HikmaFor profitMKTGOct 24, 2014
Meda PharmaceuticalsFor profitMKTGAug 31, 2009
Meda PharmaceuticalsFor profitNDA2Aug 31, 2009
MylanFor profitNDANov 1, 1996
MylanFor profitNDA2Nov 1, 1996
MylanFor profitMKTGNov 1, 1996
NovartisFor profitMKTGMay 31, 2012
Padagis UsFor profitMKTGMay 8, 2014
Padagis UsFor profitSYNMar 17, 2017
PerrigoFor profitMKTGMay 8, 2014
PerrigoFor profitSYNFeb 18, 2021
Rising PharmaceuticalsFor profitMKTGNov 1, 1996
SandozFor profitMKTGMay 31, 2012
SandozFor profitSYNMay 31, 2012
Saptalis PharmaceuticalsFor profitMKTGAug 23, 2019
Sciegen PharmaceticalsFor profitMKTGAug 23, 2019
Somerset PharmaceuticalsFor profitMKTGMar 29, 2019
Sun PharmaceuticalsFor profitMKTGJun 21, 2010
Sun PharmaceuticalsFor profitSYNJun 21, 2010
TevaFor profitMKTGApr 8, 2025
Upsher-Smith LaboratoriesFor profitMKTGMar 17, 2017
ViatrisFor profitMKTGOct 15, 2008
West-Ward PharmaceuticalFor profitMKTGOct 24, 2014
Zydus Discovery DMCCFor profitMKTGAug 14, 2017