RIZATRIPTAN BENZOATE
Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist indicated for the acute treatment of migraine with or without aura. The medication is approved for use in both adult and pediatric patients aged 6 to 17 years. It is intended specifically for the treatment of active migraine attacks rather than the prevention of future episodes and should only be administered after a clear diagnosis of migraine has been established. The drug is not indicated for the management of cluster headaches or hemiplegic and basilar migraines.
How RIZATRIPTAN BENZOATE Works
Rizatriptan benzoate exerts its therapeutic effect by binding with high affinity to human cloned 5-HT 1B/1D receptors. These receptors are located on the sensory nerves of the trigeminal system and on intracranial blood vessels. By activating these specific serotonin receptors, the drug addresses the physiological processes associated with migraine headaches.
Details
- Status
- Discontinued
- First Approved
- 2012-12-31
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, ORALLY DISINTEGRATING
RIZATRIPTAN BENZOATE Approval History
What RIZATRIPTAN BENZOATE Treats
1 indicationsRIZATRIPTAN BENZOATE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
RIZATRIPTAN BENZOATE 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.
Drugs Similar to RIZATRIPTAN BENZOATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06473597 | 2023-12-20 | Ph 4 | recruiting | A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache |
| NCT00812006 results posted | 0462-085 2008_597 | Ph 3 | completed | A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis |
| NCT01004263 results posted | 0462-086 2009_680 | Ph 3 | completed | A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3) |
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.
RIZATRIPTAN BENZOATE FDA Label Details
Indications & Usage
RIZATRIPTAN BENZOATE is indicated for the treatment of Migraine.
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RIZAFILM
Full clinical data, patents, trials, and competitive landscape for rizatriptan benzoate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.