TOSYMRA (sumatriptan)
TOSYMRA is a serotonin (5-HT 1B/1D) receptor agonist indicated for the acute treatment of migraine with or without aura in adults. It is intended for use only after a clear diagnosis of migraine has been established and is not indicated for the preventive treatment of migraine or for cluster headaches. If a patient does not respond to the initial treatment, the diagnosis should be reconsidered before further administration.
How TOSYMRA Works
Sumatriptan functions as an agonist that binds with high affinity to 5-HT 1B/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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-01-25
- Patent Cliff
- 2031
- Routes
- NASAL
- Dosage Forms
- SPRAY
TOSYMRA Approval History
What TOSYMRA Treats
1 indicationsTOSYMRA is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
TOSYMRA 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 TOSYMRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05108688 | FMASU MD 209/2021 | Ph 4 | completed | Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache |
| NCT01430442 results posted | CN170-003 | Ph 2 | completed | Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine |
| NCT00892203 | CBGG492A2204 2008-005392-10 | Ph 2 | completed | Efficacy and Safety of BGG492 in the Treatment of Migraine |
| NCT04197349 | ALD1910-CLIN-001 18902A | Ph 1 | completed | Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman |
| NCT04355845 | B7981025 | Ph 1 | completed | A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS. |
| NCT00804973 results posted | 12258 I2W-MC-DMAB | Ph 2 | terminated | Study in Participants With Acute Migraines Headaches |
| NCT03076970 results posted | 16885 COL MIG-118, H8H-CD-LAHI | Ph 1 | completed | Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Participants |
| NCT03310411 results posted | 16926 H8H-MC-LAHU | Ph 1 | completed | A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants |
| NCT02932488 | NP3 | Ph 1 | terminated | Cerebral Pharmacodynamic Effects of 5-HT1B Receptor Stimulation |
| NCT02741310 results posted | 20140255 2015-004537-28 | Ph 1 | completed | Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan |
| NCT01071317 results posted | 09-08-248 | Ph 4 | completed | Trial of Comprehensive Migraine Intervention |
| NCT01807234 KSPN results posted | NA00075486 | Ph 4 | completed | Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine |
| NCT01462812 results posted | OPN-SUM-MIG-3301 | Ph 3 | completed | Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine |
| NCT01579383 | ALD403-CLIN-001 | Ph 1 | completed | Safety Tolerability and Pharmacokinetics of ALD403 |
| NCT01248468 results posted | 176-P-401 | Ph 4 | completed | Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine |
| NCT01507610 | OPN-SUM-1302 | Ph 1 | completed | Bioavailability Study to Compare OPTINOSE SUMATRIPTAN With IMITREX® in Healthy Subjects |
| NCT01016834 results posted | ZX001-0901 | Ph 4 | completed | Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine |
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.
TOSYMRA FDA Label Details
Indications & Usage
FDA Label (PDF)TOSYMRA is indicated for the treatment of Migraine.
TOSYMRA Patents & Exclusivity
Patents (9 active)
Pro Intelligence Preview
Deep insights for TOSYMRA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 9 active patents
Trial Analysis
- • 17 total trials
- • Stage: Declining
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment