ELETRIPTAN HYDROBROMIDE · REGCON HOLDINGS
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.
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.
Details
- Status
- Prescription
- First Approved
- 2002-12-26
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
ELETRIPTAN HYDROBROMIDE Approval History
What ELETRIPTAN HYDROBROMIDE Treats
2 indicationsELETRIPTAN 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
ELETRIPTAN HYDROBROMIDE 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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Active Pipeline
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Key Completed Trials
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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.
ELETRIPTAN HYDROBROMIDE FDA Label Details
Indications & Usage
Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been establish...
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Full clinical data, patents, trials, and competitive landscape for eletriptan hydrobromide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.