ZOLMITRIPTAN
Zolmitriptan is a serotonin (5-HT) 1B/1D receptor agonist indicated for the acute treatment of migraine with or without aura in adults. It is intended for use only after a clear diagnosis of migraine has been established and is not indicated for the prevention of migraine attacks. The medication is specifically for the treatment of active migraine symptoms rather than cluster headaches or prophylactic therapy. If a patient does not respond to the initial treatment, the diagnosis of migraine should be reevaluated before further administration.
How ZOLMITRIPTAN Works
Zolmitriptan functions as an agonist that binds with high affinity to human 5-HT 1B and 5-HT 1D receptors. Its therapeutic effect is believed to stem from activating these receptors on intracranial blood vessels and sensory nerves within the trigeminal system. This activation leads to the constriction of cranial vessels and the inhibition of pro-inflammatory neuropeptide release, addressing the vasodilation and nerve signaling associated with migraine attacks. The drug's N-desmethyl metabolite also contributes to this activity through similar receptor binding.
Details
- Status
- Discontinued
- First Approved
- 2013-05-14
- Routes
- ORAL, NASAL
- Dosage Forms
- TABLET, TABLET, ORALLY DISINTEGRATING, SPRAY
Companies
ZOLMITRIPTAN Approval History
What ZOLMITRIPTAN Treats
1 indicationsZOLMITRIPTAN is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
ZOLMITRIPTAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03145467 | 2015TPF039 | Ph 4 | completed | Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine in Emergency Department |
| NCT02609945 | TRIP-AM-1035 | Ph 1 | completed | Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults |
| NCT01211145 TEENZ results posted | D1220C00001 | Ph 4 | completed | Zomig - Treatment of Acute Migraine Headache in Adolescents |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZOLMITRIPTAN FDA Label Details
Indications & Usage
ZOLMITRIPTAN is indicated for the treatment of Migraine.
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ZOMIG
Full clinical data, patents, trials, and competitive landscape for zolmitriptan.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.