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zolmitriptan

Trade name: zomig

Small moleculeapproved

Approved

Nov 25, 1997

Zolmitriptan (Zomig; formerly 311C90) is a novel 5-hydroxytryptamine (5HT)1B/1D receptor agonist with proven efficacy in the acute treatment of migraine with or without preceding aura. The N-desmethyl metabolite also has high affinity for 5-HT1B/1D and moderate affinity for 5-HT1A receptors. Migraines are likely due to local cranial vasodilatation and/or to the release of sensory neuropeptides (vasoactive intestinal peptide, substance P and calcitonin gene-related peptide) through nerve endings in the trigeminal system. The therapeutic activity of Zomig for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system, which result in cranial vessel constriction, and inhibition of pro-inflammatory neuropeptide release. — NCATS

Clinical trial activity

20 trials · 18 clinical orgs · 24 marketing orgs

Phase 1
8
Phase 2
4
Phase 3
5
Phase 4
5

Earliest trial started Sep 1, 2002 (NCT00617747)

Timeline

1990s

  1. Nov 25, 1997

    Earliest FDA Approval

  2. Nov 25, 1997

    Amneal Pharmaceuticals — NDA Secondary Org

2000s

  1. Feb 13, 2001

    AstraZeneca — First NDA Organization

  2. Feb 13, 2001

    AstraZeneca — NDA Organization

  3. Jan 1, 2002

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

  4. Sep 30, 2003

    Amneal Pharmaceuticals — Marketing Organization

2010s

  1. Jan 1, 2010

    AstraZeneca — Earliest Phase 1 Sponsor(trial)

  2. May 14, 2013

    Apotex — Marketing Organization

  3. May 14, 2013

    Glenmark Pharmaceuticals — Marketing Organization

  4. May 14, 2013

    Mylan — Marketing Organization

  5. May 14, 2013

    Natco Pharma — Marketing Organization

  6. Mar 4, 2014

    Ani Pharmaceuticals — Marketing Organization

  7. Mar 4, 2014

    Teva — Marketing Organization

  8. Apr 9, 2014

    Invagen Pharms — Marketing Organization

  9. Nov 13, 2014

    Sun Pharmaceuticals — Marketing Organization

  10. Nov 20, 2014

    Jubilant Innovation Ltd. — Marketing Organization

  11. Sep 30, 2015

    Alembic — Marketing Organization

  12. Sep 30, 2015

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  13. Sep 30, 2015

    Neogen — Marketing Organization

  14. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  15. May 11, 2016

    Aurobindo Pharma — Marketing Organization

  16. May 20, 2016

    Ajanta Pharma Ltd — Marketing Organization

  17. Feb 27, 2017

    Perrigo — Marketing Organization

  18. Jun 30, 2017

    Appco Pharma — Marketing Organization

  19. Jun 30, 2017

    TWi Biotechnology, Inc. — Marketing Organization

  20. Jul 11, 2018

    Zydus Discovery DMCC — Marketing Organization

  21. Sep 20, 2019

    Rising Pharmaceuticals — Marketing Organization

  22. Oct 21, 2019

    Orbion Pharms — Marketing Organization

  23. Oct 21, 2019

    Orchid Pharma — Marketing Organization

2020s

  1. Sep 30, 2021

    Padagis Us — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 25, 1997

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)CCC1=CNC2=C1C=C(C[C@H]3COC(=O)N3)C=C2
Mol. weight
287.3568 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

Sources

Also known as

  • 311c90
  • 311c90
  • 311c90
  • 311c90
  • 311c90
  • 4-((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)-2-oxazolidinone
  • 4-[[3-(2-dimethylaminoethyl)-1h-indol-5-yl]methyl]oxazolidin-2-one
  • 4-[[3-(2-dimethylaminoethyl)-1h-indol-5-yl]methyl]oxazolidin-2-one
  • ascotop
  • astra brand of zolmitriptan
  • astrazeneca brand of zolmitriptan
  • ferrer brand of zolmitriptan
  • flezol
  • (s)-4-({3-[2-(dimethylamino)ethyl]-1h-indol-5-yl}methyl)-1,3-oxazolidin-2-one
  • (s)-4-({3-[2-(dimethylamino)ethyl]-1h-indol-5-yl}methyl)-1,3-oxazolidin-2-one
  • zeneca brand of zolmitriptan
  • zipton
  • zolmitriptan
  • zolmitriptan
  • zolmitriptan
  • zolmitriptan
  • zolmitriptan
  • zolmitriptan
  • zolmitriptan
  • zolmitriptan
  • zolmitriptan
  • zolmitriptan
  • zolmitriptan
  • zolmitriptanum
  • zolmitriptanum
  • zomig
  • zomig
  • zomig
  • zomig
  • zomigoro
  • zomigoro
  • zomig-zmt
  • zomig-zmt
  • zominat

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06074016Phase 1Jul 12, 2023Food and Drug Administration, Institut Hospital del Mar d'Investigacions Mèdiques
NCT06089356Phase 4Jan 1, 2023Kafrelsheikh University, Tanta University
NCT05019430Early Phase 1 (Phase 1)Oct 15, 2021National Institute on Drug Abuse (NIDA), University of Kentucky
NCT04969497Phase 1Jun 24, 2021Zosano Pharma Inc.
NCT03978403Phase 1May 29, 2019Zosano Pharma Inc.
NCT03708744Phase 1Nov 1, 2018Zosano Pharma Inc.
NCT03377257Phase 4Jan 1, 2018Xijing Hospital
NCT03275922Phase 3Dec 4, 2017AstraZeneca, Impax Laboratories
NCT02905227Phase 1Sep 1, 2016Acorda Therapeutics
NCT02745392Phase 2/Phase 3 (Phase 3)Jun 1, 2016Zosano Pharma Inc.
NCT03145467Phase 4Jan 1, 2016Pamukkale University
NCT02609945Phase 1Nov 1, 2015Acorda Therapeutics
NCT01619176N/AOct 1, 2012Chinese Academy of Medical Sciences, Jiao Tong University
NCT01211145Phase 4Sep 1, 2010AstraZeneca, Old Dominion University
NCT01085123Phase 1May 1, 2010AstraZeneca, IQVIA
NCT01276977N/AApr 1, 2008California Medical Clinic for Headache
NCT00442936Phase 3Feb 15, 2007Merck
NCT00637286Phase 4Jul 1, 2004AstraZeneca
NCT00617695Phase 3Sep 1, 2003AstraZeneca
NCT00617747Phase 3Sep 1, 2002AstraZeneca
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit6532002
Zosano Pharma Inc.For profit4422016
Acorda TherapeuticsFor profit2212015
California Medical Clinic for HeadacheAcademic/Hospital1112008
Chinese Academy of Medical SciencesAcademic/Hospital1112012
Food and Drug AdministrationGovernment1012023
Impax LaboratoriesFor profit1112017
Institut Hospital del Mar d'Investigacions MèdiquesAcademic/Hospital1112023
IQVIAFor profit1012010
Jiao Tong UniversityAcademic/Hospital1012012
Kafrelsheikh UniversityAcademic/Hospital1012023
MerckFor profit1112007
National Institute on Drug Abuse (NIDA)Government1012021
Old Dominion UniversityAcademic/Hospital1012010
Pamukkale UniversityAcademic/Hospital1112016
Tanta UniversityAcademic/Hospital1112023
University of KentuckyAcademic/Hospital1112021
Xijing HospitalAcademic/Hospital1112018
18 organizations
Page 1 / 1

Marketing (31)

OrganizationOrg typeRelationshipDate
Ajanta Pharma LtdFor profitMKTGMay 20, 2016
AlembicFor profitMKTGSep 30, 2015
AlembicFor profitSYNSep 30, 2015
Amneal PharmaceuticalsFor profitNDA2Nov 25, 1997
Amneal PharmaceuticalsFor profitMKTGSep 30, 2003
Ani PharmaceuticalsFor profitMKTGMar 4, 2014
Ani PharmaceuticalsFor profitSYNMar 4, 2014
ApotexFor profitMKTGMay 14, 2013
Appco PharmaFor profitMKTGJun 30, 2017
AstraZenecaFor profitNDAFeb 13, 2001
Aurobindo PharmaFor profitMKTGMay 11, 2016
Aurobindo PharmaFor profitSYNMay 11, 2016
Glenmark PharmaceuticalsFor profitMKTGMay 14, 2013
Invagen PharmsFor profitMKTGApr 9, 2014
Jubilant Innovation Ltd.For profitMKTGNov 20, 2014
Macleods Pharmaceuticals, LtdFor profitMKTGSep 30, 2015
MylanFor profitMKTGMay 14, 2013
MylanFor profitSYNSep 20, 2019
Natco PharmaFor profitMKTGMay 14, 2013
NeogenFor profitMKTGSep 30, 2015
Orbion PharmsFor profitMKTGOct 21, 2019
Orchid PharmaFor profitMKTGOct 21, 2019
Padagis UsFor profitMKTGSep 30, 2021
PerrigoFor profitMKTGFeb 27, 2017
Rising PharmaceuticalsFor profitMKTGSep 20, 2019
Rising PharmaceuticalsFor profitSYNSep 20, 2019
Sun PharmaceuticalsFor profitMKTGNov 13, 2014
TWi Biotechnology, Inc.For profitMKTGJun 30, 2017
TevaFor profitMKTGMar 4, 2014
Zydus Discovery DMCCFor profitMKTGJul 11, 2018
Zydus Discovery DMCCFor profitSYNMay 15, 2013