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Data updated: May 26, 2026

MAXALT (rizatriptan benzoate)

Trial Activity: Mature 1 active trials
CNS Approved 1998-06-29

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.

Source: FDA Label • Merck

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

Organon and Co conducting 2 trials (50%)
3 indications explored (Focused)
migraine (2 trials)
acute migraine with or without aura in adolescents (1 trials)
episodic migraine (1 trials)
5
Indications
--
Phase 3 Trials
1
Priority Reviews
27
Years on Market

Details

Status
Prescription
First Approved
1998-06-29
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: RIZATRIPTAN BENZOATE

MAXALT Approval History

1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
36 FDA actions from 1998 to 2019 · 2 indication expansions
Oct 2019 SUPPL
Label · Labeling
Jun 2015 SUPPL
Mfg · Manufacturing (CMC)
May 2014 SUPPL
Mfg · Manufacturing (CMC)

What MAXALT Treats

1 indications

MAXALT is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Migraine
Source: FDA Label

MAXALT Competitive Set

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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
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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