TheraRadar
Data updated: May 26, 2026

ELETRIPTAN HYDROBROMIDE

CNS Approved 2017-06-16

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. It serves as a targeted therapy for managing active migraine attacks rather than a prophylactic measure.

Source: FDA Label • Teva

How ELETRIPTAN HYDROBROMIDE Works

Eletriptan hydrobromide functions by binding with high affinity to 5-HT 1B, 5-HT 1D, and 5-HT 1F receptors. Its therapeutic effect is attributed to agonist activity at the 5-HT 1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system. This activation leads to the constriction of cranial vessels and inhibits the release of pro-inflammatory neuropeptides that contribute to migraine symptoms. By addressing the local cranial vasodilatation and nerve signaling associated with the condition, the drug alleviates the migraine headache.

Source: FDA Label
9
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-06-16
Routes
ORAL
Dosage Forms
TABLET

ELETRIPTAN HYDROBROMIDE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
32 FDA actions from 2017 to 2025
Jul 2025 ORIGINAL
Update
Feb 2024 SUPPL
Label · Labeling
Jul 2022 ORIGINAL
Update

What ELETRIPTAN HYDROBROMIDE Treats

2 indications

ELETRIPTAN HYDROBROMIDE is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Migraine
  • Cluster Headache
Source: FDA Label

ELETRIPTAN HYDROBROMIDE Competitive Set

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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.

ELETRIPTAN HYDROBROMIDE FDA Label Details

Indications & Usage

ELETRIPTAN HYDROBROMIDE is indicated for the treatment of Migraine; Cluster Headache.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.