ONZETRA XSAIL (sumatriptan succinate)
ONZETRA XSAIL is indicated for the treatment of Migraine.
How ONZETRA XSAIL Works
Sumatriptan functions by binding with high affinity to human cloned 5-HT 1B/1D receptors. It acts as an agonist at these receptors located on intracranial blood vessels and the sensory nerves of the trigeminal system. This activation results in the constriction of cranial blood vessels and the inhibition of pro-inflammatory neuropeptide release.
Details
- Status
- Prescription
- First Approved
- 2016-01-27
- Patent Cliff
- 2034
- Routes
- NASAL
- Dosage Forms
- POWDER
ONZETRA XSAIL Approval History
What ONZETRA XSAIL Treats
1 indicationsONZETRA XSAIL is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
ONZETRA XSAIL 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 ONZETRA XSAIL
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.
ONZETRA XSAIL FDA Label Details
Indications & Usage
FDA Label (PDF)ONZETRA XSAIL is indicated for the treatment of Migraine.
ONZETRA XSAIL Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for ONZETRA XSAIL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 18 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.