IMITREX STATDOSE (sumatriptan succinate)
Imitrex Statdose (sumatriptan succinate) is a subcutaneous injection indicated for the acute treatment of migraine, with or without aura, and cluster headache in adult patients. The medication is intended for use only after a clear diagnosis of these conditions has been established and is not indicated for prophylactic therapy. If a patient does not respond to the initial treatment of an attack, the diagnosis should be reconsidered before further administration.
How IMITREX STATDOSE Works
Sumatriptan is a serotonin receptor agonist that binds with high affinity to human cloned 5-HT1B/1D receptors. It exerts its therapeutic effects by acting on these receptors located on intracranial blood vessels and sensory nerves of the trigeminal system. This activation results in the constriction of cranial vessels and the inhibition of pro-inflammatory neuropeptide release.
Details
- Status
- Prescription
- First Approved
- 1992-12-28
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
IMITREX STATDOSE Approval History
What IMITREX STATDOSE Treats
2 indicationsIMITREX STATDOSE is approved for 2 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
- Cluster Headache
IMITREX STATDOSE 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.
Drugs Similar to IMITREX STATDOSE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01381796 | PROT-15-NP101-013 | Ph 1 | completed | Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults |
| NCT00723983 NP101-011 | PROT-15-NP101-011 | Ph 1 | completed | Phase I, Open Label, Single-Dose, Four Way Crossover Study to Compare the PK of NP101 With Oral Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period |
| NCT00920686 results posted | NXN-188-203 | Ph 2 | completed | Study of NXN 188 for the Treatment of Migraine With Aura |
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.
IMITREX STATDOSE FDA Label Details
Indications & Usage
FDA Label (PDF)IMITREX STATDOSE 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.