MAXALT-MLT (rizatriptan benzoate)
MAXALT-MLT (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 between the ages of 6 and 17 years. It is intended specifically for the treatment of active migraine attacks rather than the prevention of future episodes. Use of this therapy requires a confirmed diagnosis of migraine and is not indicated for cluster headaches or certain specific types of migraine, such as hemiplegic or basilar migraine.
How MAXALT-MLT Works
Rizatriptan functions by binding with high affinity to human cloned 5-HT 1B/1D receptors. The drug is believed to exert its therapeutic effects by acting on these receptors located on intracranial blood vessels and sensory nerves of the trigeminal system. By activating these specific serotonin receptors, the medication helps manage the symptoms associated with acute migraine attacks.
Details
- Status
- Prescription
- First Approved
- 1998-06-29
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
MAXALT-MLT Approval History
What MAXALT-MLT Treats
1 indicationsMAXALT-MLT is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
MAXALT-MLT 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 |
|---|---|---|---|---|
| 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.
MAXALT-MLT FDA Label Details
Indications & Usage
FDA Label (PDF)MAXALT-MLT 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.