Approval Probability
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TREXIMA · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TREXIMA tablet followed by IMITREX injection (4mg) | EXPERIMENTAL | TREXIMA™ (sumatriptan succinate / naproxen sodium) Tablet followed by IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System® |
| TREXIMA tablet followed by IMITREX injection (6mg) | EXPERIMENTAL | TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System® |
| IMITREX tablet (100mg) | ACTIVE_COMPARATOR | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
| Name | Type | Description |
|---|---|---|
| TREXIMA™ | DRUG | sumatriptan succinate / naproxen sodium tablet |
| IMITREX® (4mg) | DRUG | sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System® |
| IMITREX® (6mg) | DRUG | sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System® |
| IMITREX Tablet 100mg | DRUG | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
Inclusion Criteria: * Healthy adult males and females between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies and other tests. ...
TREXIMA is an investigational small molecule developed by GSK plc for migraine disorders. It combines sumatriptan succinate and naproxen sodium in a single tablet. TREXIMA is in Phase 1 clinical development and is not approved. It has been studied in one completed trial with 30 participants.
TREXIMA is being developed for the treatment of migraine disorders. It is a fixed-dose combination tablet containing sumatriptan succinate and naproxen sodium. Development is at the Phase 1 stage, so TREXIMA is investigational and has not been approved for prescribing in migraine or any other indication.
TREXIMA is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the sumatriptan succinate and naproxen sodium combination tablet in migraine disorders.
TREXIMA is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. Because it remains investigational, TREXIMA has not been approved by the FDA or any other regulatory authority for migraine disorders or any other use.
TREXIMA has been evaluated in one completed Phase 1 trial, NCT00875784. That open-label, randomized, three-period crossover study enrolled 30 healthy adult volunteers in the United States and assessed sumatriptan pharmacokinetics for a TREXIMA tablet followed by IMITREX (sumatriptan succinate). No TREXIMA trials are currently active.
Yes. TREXIMA and TREXIMA™ refer to the same investigational product from GSK plc. The trademark symbol is simply a stylized form of the name, so searches using either version point to the same sumatriptan succinate and naproxen sodium combination tablet being studied in migraine disorders.