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Zolmitriptan

Phase 4FDA approved

Migraine | Small molecule | Neurology |AstraZeneca PLC|Trials Updated: Apr 6, 2009

Zolmitriptan development status

FDA approval on record Feb 13, 2001
Approval holderAstrazeneca
ApplicationNDA021231
Highest phase Phase 4 (NCT01211145)
Phase scored for AZNPhase 3
Registered trials 3 across 1 sponsor since Feb 2008

Zolmitriptan target and mechanism

Molecular targetHTR1B, HTR1D
Target classAgonist
ModalitySmall molecule

Also known as Zomig

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment2,114

FDA Designations

No designations recorded

Zolmitriptan clinical trials

Zolmitriptan · 1 trial · 1 indication

Phase 3 1
NCT00617747Efficacy and Tolerability of Zolmitriptan Nasal SprayMigraine
COMPLETED2,114 Analytics
PHASE3COMPLETED
Efficacy and Tolerability of Zolmitriptan Nasal Spray
MigraineUnlock trial analytics

Study Endpoints

Primary Endpoints

Improvement in migraine headache pain from severe or moderate to mild or none
15 minutes after the initial dose of trial treatment

Secondary Endpoints

Headache response rate
30 minutes and 1, 2 and 4 hours after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ZolmitriptanDRUG5mg Nasal Spray
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject has an established diagnosis of migraine headache, with or without aura * Subject has a medical history indicating the presence of migraine attacks for at least 1 year before the start of the trial or a minimum of 2 and maximum of 6 migraine attacks per month on averag...

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Competitive Landscape -Migraine 43 trials

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Frequently asked questions about Zolmitriptan

What is zolmitriptan used for?

Zolmitriptan is used for the treatment of migraine. It is a small molecule developed by AstraZeneca PLC under the ticker AZN and has been studied in a Phase 3 clinical program in neurology, with a completed trial enrolling 2,114 participants with migraine.

What does zolmitriptan target?

Zolmitriptan targets the serotonin receptors HTR1B and HTR1D, where it acts as an agonist. By activating these receptor subtypes, the drug is designed to produce its antimigraine effects. Both HTR1B and HTR1D are the molecular targets associated with this small molecule.

Who makes zolmitriptan?

Zolmitriptan is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor associated with the drug's clinical development program in migraine, a Phase 3 effort that includes a completed trial of 2,114 participants.

What phase is zolmitriptan in?

Zolmitriptan is in Phase 3 clinical development for migraine. Its development program includes one completed Phase 3 trial, and no trials are currently listed as active. The drug is investigational in this dataset and is not described here as approved by the FDA.

What clinical trials is zolmitriptan in?

Zolmitriptan has been studied in the Phase 3 trial NCT00617747, titled Efficacy and Tolerability of Zolmitriptan Nasal Spray. That trial is completed, enrolled 2,114 participants with migraine, was randomized, double blind, and placebo controlled, and included adults 18 years and older of all sexes.