SUMATRIPTAN · REGCON HOLDINGS
Sumatriptan nasal spray is a serotonin (5-HT 1B/1D) receptor agonist indicated for the acute treatment of migraine with or without aura in adult patients. The medication is intended for use only after a clear diagnosis of migraine has been established and is not indicated for the prophylactic prevention of migraine attacks. It is specifically used for active migraine episodes rather than cluster headaches. If a patient does not respond to the initial treatment, the diagnosis of migraine should be reevaluated before further administration.
How SUMATRIPTAN Works
Sumatriptan functions as an agonist that binds with high affinity to human 5-HT 1B/1D receptors. By activating these receptors on intracranial blood vessels and sensory nerves within the trigeminal system, the drug promotes the constriction of cranial vessels. Additionally, this process inhibits the release of pro-inflammatory neuropeptides. These combined actions are the mechanism through which the drug exerts its therapeutic effects on migraine headaches.
Details
- Status
- Prescription
- First Approved
- 2016-02-19
- Routes
- NASAL
- Dosage Forms
- SPRAY
SUMATRIPTAN Approval History
What SUMATRIPTAN Treats
2 indicationsSUMATRIPTAN is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
- Cluster Headache
SUMATRIPTAN 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 SUMATRIPTAN
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.
SUMATRIPTAN FDA Label Details
Indications & Usage
Sumatriptan nasal spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan nasal spray, reconsider the diagnosis of migraine before Sumatriptan nasal spray is administered to treat any subsequent attacks. Sumatriptan is not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan nasal spray have not been established for cluster headache. Sumatriptan is a ser...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.