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Label indication TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use : Use only if a clear diagnosis of migraine has been established ( 1 ) Not indicated for the preventive treatment of migraine ( 1 ) Not indicated for the treatment… FDA label
Sumatriptan · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sumatriptan Succinate Tablets 100 mg |
| 2 | ACTIVE_COMPARATOR | Imitrex® Tablets 100 mg |
| Name | Type | Description |
|---|---|---|
| Sumatriptan Succinate Tablets 100 mg | DRUG | 100mg, single dose fasting |
| Imitrex® Tablets 100 mg | DRUG | 100mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ev...
Sumatriptan is a small molecule drug developed by Viatris Inc. (ticker VTRS), also known as Sumatriptan Succinate Tablets 100 mg. It is being studied in Phase 1 clinical development. The specific medical condition it is intended to treat has not been disclosed.
Sumatriptan targets the serotonin receptors HTR1B and HTR1D, where it acts as an agonist. By binding and activating these receptor subtypes, the drug exerts its pharmacological effect. Both HTR1B and HTR1D are the molecular targets identified for this small molecule compound.
Sumatriptan is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor responsible for the clinical development program of Sumatriptan Succinate Tablets 100 mg.
Sumatriptan is in Phase 1 clinical development. It is an investigational drug and is not approved. Two Phase 1 trials have been completed, and no trials are currently active. The program has enrolled a total of 112 participants across its completed studies.
Sumatriptan has been evaluated in two completed Phase 1 trials. NCT00650247 was a food-effect study comparing Sumatriptan Succinate Tablets 100 mg to Imitrex Tablets 100 mg in 57 healthy volunteers. NCT00648466 was a fasting study of the same comparison in 55 healthy volunteers. Both were conducted in the United States.