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Data updated: May 26, 2026

RELPAX (eletriptan hydrobromide)

CNS Approved 2002-12-26

RELPAX (eletriptan hydrobromide) is a serotonin (5-HT 1B/1D) receptor agonist indicated for the acute treatment of migraine with or without aura in adults. The medication is intended for use only after a clear diagnosis of migraine has been established and is not indicated for the preventive treatment of migraines or for cluster headaches. If a patient does not respond to the initial treatment, the diagnosis should be reconsidered before further administration.

Source: FDA Label • UPJOHN

How RELPAX Works

RELPAX functions as an agonist at 5-HT 1B/1D receptors located on intracranial blood vessels and sensory nerves within the trigeminal system. By activating these receptors, the drug promotes the constriction of cranial vessels and inhibits the release of pro-inflammatory neuropeptides. These actions counteract the local cranial vasodilation and neuropeptide release thought to be responsible for migraine symptoms.

1
Indication
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2002-12-26
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: ELETRIPTAN HYDROBROMIDE

RELPAX Approval History

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
28 FDA actions from 2002 to 2020
Mar 2020 SUPPL
Label · Labeling
Sep 2015 SUPPL
Mfg · Manufacturing (CMC)
Dec 2013 SUPPL
Mfg · Manufacturing (CMC)

What RELPAX Treats

1 indications

RELPAX is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Migraine
Source: FDA Label

RELPAX Competitive Set

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Active Pipeline

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Key Completed Trials

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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.

RELPAX FDA Label Details

Indications & Usage

FDA Label (PDF)

RELPAX 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.