MAXALT (rizatriptan benzoate)
MAXALT (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 adults and pediatric patients aged 6 to 17 years. It is intended for use only after a clear diagnosis of migraine has been established and is not indicated for the preventive therapy of migraine or the treatment of cluster headaches. Furthermore, the drug is not indicated for the management of hemiplegic or basilar migraine.
How MAXALT Works
Rizatriptan functions by binding with high affinity to human cloned 5-HT 1B/1D receptors. The drug's therapeutic effects are presumably exerted by binding to these receptors located on intracranial blood vessels and sensory nerves of the trigeminal system. By acting as an agonist at these specific serotonin receptor sites, the medication addresses the physiological pathways involved in an acute migraine attack.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-06-29
- Routes
- ORAL
- Dosage Forms
- TABLET
MAXALT Approval History
What MAXALT Treats
1 indicationsMAXALT is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
MAXALT 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
4 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) |
| NCT00719134 results posted | 2007-P-000220 | Ph 4 | completed | The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache |
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.
MAXALT FDA Label Details
Indications & Usage
FDA Label (PDF)MAXALT is indicated for the treatment of Migraine.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment